血糖检测仪论文中英文资料对照外文翻译文献
医院 POCT 血糖仪应用现状分析论文
５．统计学分析：应用 ＳＰＳＳ 软件对所测数据进行 统计，结果以 ｘ-±ｓ 表示。
结果
一、便携式血糖仪数量和品牌 ３ 次调查数据显示，院内便携式血糖仪共涉及 ５ 个品牌，有些临床科室的血糖仪数量和品牌经常发 生变化（表 １）。 二、卫计委临检中心室间质评样本检测结果 ２０１３ 年我院开始参加卫计委临检中心的便携 式血糖仪室间质评活动。 对 ４ 个品牌的 ４８ 台血糖 仪进行了室间质控品的检测，并做统计分析。 根据 卫计委 ２０１０ 年颁发的《 试行》 规范要求：葡萄糖浓 度 ＜５．５ ｍｍｏｌ ／Ｌ， ＣＶ ＜１０．０％； 葡 萄 糖 浓 度 ＞ ５．５ｍｍｏｌ ／Ｌ，ＣＶ ＜７．５％，品牌Ⅲ的便携式血糖仪有 ３ 个浓度的检测结果精密度均未达到要求；余 ３ 个 品牌均符合要求（表 ２）。 三、便携式血糖仪与全 自 动 生 化 分 析 仪 比 对 结果
材料与方法
一、材料 １．仪器：参加室间质评的便携式血糖仪品牌包 括 罗 氏 ＡＣＣＵ－ＣＨＥＫ、 雅 培 Ｏｐｔｉｕｍ Ｘｃｅｅｄ、 贝 朗 Ｏｍｎｉｔｅｓｔ ｐｌｕｓ、拜尔康 Ｃｏｎｔｏｕｒ ＴＳ；参加比对的便携 式血糖仪品牌包括罗氏 ＡＣＣＵ－ＣＨＥＫ、雅培 Ｏｐｔｉｕｍ Ｘｃｅｅｄ、贝朗 Ｏｍｎｉｔｅｓｔ ｐｌｕｓ、拜尔康 Ｃｏｎｔｏｕｒ ＴＳ、强生 ＵｌｔｒａＶｕｅ。 比对仪器为日本日立 ７６００－１１０ 型全自动 生化分析仪。 ２．质控品和试剂：室间质评样本由卫计委临检 中心提供，共 ５ 个浓度；试剂干片、室内质控由相应 的仪器厂商提供。 生化仪血糖试剂、室内质控品、校 准品由北京利德曼生化公司提供。 二、方法 １．调查问卷：分别于 ２０１３ 年 ３、６、９ 月份对军事 医学科学院附属医院的便携式血糖仪的数量、品牌 及使用情况进行问卷调查。 ２．精密度评估：２０１３ 年 ３ 月，采用卫计委临检
NovaStatStrip血糖仪在葡萄糖钳夹试验中进行实时血糖确定的精密度与可靠性
Technology）2010年9月第4卷第5期©糖尿病技术协会（Diabetes Technology Society）NOVAStatStrip®血糖仪在葡萄糖钳夹试验中进行实时血糖测定的准确度和可靠性Atoosa Rabiee, M.D.,1,2J. Trent Magruder, B.S.,1Crystal Grant, M.D., Ph.D.,1 Rocio Salas-Carrillo, M.D.,1 Audrey Gillette, ,3 Jeffrey DuBois, Ph.D.,4 Richard P. Shannon, M.D.,5 Dana K. Andersen, M.D.,1 and Dariush Elahi, Ph.D.,1,2作者联系方式：1 Department of Surgery, Johns Hopkins University School of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; 2 Department of Medicine, Johns Hopkins University School of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; 3Department of Pathology, Johns Hopkins University School of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; 4Nova Biomedical, Waltham, Massachusetts; and 5Department of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania缩写：EGA 误差栅格分析（error grid analysis），PG 血浆葡萄糖（plasma glucose），SMT 标准膳食耐量试验（standardized meal tolerance test），YSI Yellow Springs Instruments公司关键词：贝克曼，葡萄糖钳夹试验，血糖仪，血浆葡萄糖，YSI通讯作者：Dariush Elahi, Ph.D., Departments of Surgery and Medicine, Johns Hopkins Bayview Medical Center, 4940 Eastern Ave., Baltimore, MD 21224-2780; Email：前言葡萄糖钳夹技术首先由Andres及其同事于1966年论述，1被认为是现今最新的葡萄糖稳态的测量技术。
毕业论文文献内容编排中文与英文对照
毕业论文文献内容编排中文与英文对照在毕业论文的写作过程中，文献内容的编排是非常重要的一环。
其中，中文与英文对照是必不可少的部分。
在撰写毕业论文时，如何合理地安排中文和英文文献内容，是需要认真考虑的问题。
下面将从文献引用、文献列表和文献翻译等方面进行详细介绍。
一、文献引用在毕业论文中，引用文献是非常常见的做法。
当引用中文文献时，应在引用的文献后标注中文作者姓名和出版年份，如“张三，2000”。
而引用英文文献时，则需要标注英文作者姓名和出版年份，如“Smith, 2010”。
在引用文献时，要注意中英文对照的一致性，确保中英文作者姓名和出版年份的对应准确无误。
二、文献列表在毕业论文的文献部分，通常会列出所有引用过的文献。
在文献列表中，中文文献和英文文献的排列顺序可以根据引用的先后顺序或按照作者姓氏的字母顺序排列。
对于中文文献，应按照作者姓名的汉语拼音首字母顺序排列；对于英文文献，则按照作者姓氏的字母顺序排列。
在文献列表中，中文文献和英文文献之间可以用空行或其他方式进行区分，以便读者清晰地识别。
三、文献翻译在撰写毕业论文时，有时会需要引用外文文献。
对于外文文献的引用，需要进行准确的翻译。
在翻译文献时，要确保翻译的准确性和流畅性。
对于中文文献，如果需要引用英文文献的内容，可以在引用的内容后附上英文原文，以便读者查阅。
同样，对于英文文献，如果需要引用中文文献的内容，也可以在引用的内容后附上中文原文。
这样做不仅可以提高文献内容的可读性，还可以确保翻译的准确性。
总之，在毕业论文的文献内容编排中，中文与英文对照是非常重要的一环。
合理地安排中英文文献内容，不仅可以提高论文的质量，还可以让读者更好地理解论文的内容。
希望以上介绍对你在撰写毕业论文时有所帮助。
毕业设计论文 电子秤 中英文 外文资料 文献 翻译
外文参考资料二：Abstract: In order to solve the weight problem often encountered in measuring the low-mass objects in the trade and daily life of the modern business, the design of a new pocket-sized electronic scales. This pocket-sized electronic scales Force Sensor gravity signals into electrical signals to measure, and measuring the results of the digital display. The pocket-sized electronic scales with a small size, light weight, easy to carry, intuitive display, measurement and high precision; complex structure, the cost disadvantages. This article focuses on the load cell works, error compensation, the main parameters of selection. And the technical and economic analysis.Keywords: pocket-sized electronic scales; weighing; sensor; error compensationCLC number: TH715. 1] sign code: A Article ID: 100 522 895 (2007) 022*******1 A needs analysisIn modern commerce and trade and everyday life, often encounter the problem of measuring the weight of the low-mass objects. Although the traditional steelyard can solve this problem, but inconvenient to carry, the efficiency is not high, the display is not intuitive and low measurement accuracy; mechanical spring balance can solve this problem, but the inertia inherent low frequency, high sensitivity, measurement accuracy is not high. With the progress and update of the micro-computer technology, integrated circuit technology, sensor technology, electronic scales rapiddevelopment, it has a responsive, high accuracy, fully functional, the display is intuitive, compact, easy to use and so on.For these reasons, in order to solve the low-mass objects weighing problem, if a small size, light weight, portable, digital display electronic scales, will be popular. Discussed below, that is, the scope of a weighing 5 kg compact electronic scales.2 DesignThe principle of the structure of the pocket-sized electronic scales shown in Figure 1. The main task is to design compact electronic scales weighing the choice of the force sensors. Dynamometer sensor types to achieve the weighing and digital display, the key is to want to force (gravity) signals into electrical signals to measure method is mainly divided into two categories: one is the direct method, namely the use of pressure magnetic sensor, piezoelectric sensor, Piezoresistive sensors directly to the force signal converted into electrical signals; the other is the indirect method, the elastic element as the sensor will pull, pressure changes in strain, displacement, or frequency, and then strain sensors, displacement sensors, or frequency sensor strain, displacement or frequency changes for power. Comprehensive comparison of a variety of sensors, use the indirect method of strain gauge force transducer.Pocket-sized electronic scale structural principle:Sensor → amplifier → CPU→ display → AöD converter3 sensor device design3.1 worksThe working principle of the strain gauge force transducer strain gauge pasted into force, force-sensitive elasticelement, the corresponding strain when the elastic element force deformation, the strain gauge into a resistance change, which led to the voltage measuring circuit changes by measuring the output voltage value, and then through the conversion can be obtained by the measurement of body weight. Since the pocket-sized electronic scales require small size, weighing in scope, precision and angle even consistency, sensor and display integration, it is selected parallel to the two holes cantilever beam strain gauge load-bearing sensor. Its characteristics are: high precision, ease of processing, simple and compact structure, strong resistance to partial load, high natural frequency.Strain gauge choice of a metal palisade metal mooring paste on the insulating substrate parked strain gages, mechanical strain resistance strain gauge feelings generally 10 - 10 - 2mm, the resistance rate of change of the attendant about 10 - 6 10 - 2 orders of magnitude, such a small change in resistance measured using the general resistance of the instrument is hard to measure out, you must use some form of measurement.Circuit into small changes in resistance rates to changes in voltage or current, in order to secondary instrument display. Bridge measurement circuit to meet this requirement. In the load cell, R 1, R 2, R 3, R 44 strain gauge resistor bridge measurement circuit shown in Figure 3. R m is the temperature compensation resistor, e is the excitation voltage, V is the output voltage.外文参考资料三：The load cell is a quality signal into a measurable electrical signal outputdevice. Must consider the actual working environment of the sensor which sensor Yin, this is essential for the correct selection of the load cell, and it is related to the sensor can work as well as its safety and service life, and the whole weighing the reliability and safety sex. On the basic concepts and methods of evaluation of the major technical indicators of the load cell, the new and old GB qualitative differences.The traditional concept, the load sensor weighing sensors, force sensors, collectively referred to using a single parameter to evaluate its measurement properties. Old GB will be completely different application objects and the use of environmental conditions "weighing" and "measured force" two sensors into one to consider, not given to distinguish between the test and evaluation methods. Old GB total of 21 indicators, were tested at room temperature; and non-linearity, hysteresis error, repeatability error, creep, the additional error of the zero temperature and the maximum error in the six indicators of the rated output additional temperature error, to determine said The level of accuracy of the weight sensor, respectively 0.02,0.03,0.05 said.Proportion to convert the output signal can be measured. Taking into account the different place of use of the acceleration due to gravity and air buoyancy on the conversion, the main performance indicators of the load cell linearity error, hysteresis error, repeatability error, creep, zero-temperature characteristics and temperature sensitivity characteristics. In a variety of weighing and measuring the quality of the system, usually the integrated error accuracy of the integrated control sensors, and integrated error band or scale error band (Figure 1) linked so that selection corresponds to a certain accuracy weighing weighing sensors. International Organization of Legal Metrology(OIML) requirements, sensor error with total weighing instrument error δ with Δ of 70% of the load cell linearity error, hysteresis error within the specified temperature range due to the effect of temperature on the sensitivity of the error the sum can not exceed the error band of δ. This allows the manufacturer of the components that make up the total measurement error adjustment to obtain the desired accuracy.The load cell conversion method is divided into photoelectric, hydraulic, electromagnetic force type, capacitive, magnetic poles change the form of vibratory gyroscope ceremony, resistance strain type, to the most extensive use of resistance strain.Electromagnetic force sensorIt uses a load-bearing stage load and the principle of electromagnetic force Equilibrium (Figure 5). Put the loading stage, the measured object at one end of the lever upward tilt; photoelectric detect the tilt signal, amplified into the coil, the electromagnetic force, so that the lever to return to equilibrium. Currents produce electromagnetic counterweight digital converter, you can determine the quality of the measured object. The electromagnetic force sensor accuracy, up to 1/2000 ~ 1/60000, but the weighing range is only tens of mg to 10 kg.Capacitive sensorsItcapacitor oscillator circuit of the oscillation frequency f and the plate spacing d is directly proportional relationship between the work (Figure 6). There are two plates, one fixed and the other one can move. Bearing load measured object, the leaf spring deflection, the distance between the twoplates changes, the oscillation frequency of the circuit also changes. The measured frequency change can be calculated to the quality of the load-bearing stage, the measured object. Capacitive sensor power consumption, low cost, accuracy of 1/200 to 1/500.Pole change the form of sensorFerromagneticcomponents in the measured object gravity under mechanical deformation, internal stress and cause changes in permeability, and also changes so that the induced voltage of the secondary coil wound on both sides of the ferromagnetic component (pole). Measure the voltage variation can be calculated added to the force on the pole, and then determine the quality of the measured object. Pole to change the form of sensor accuracy is not high, usually 1/100, applicable to the large tonnage weighing, weighing ranging from tens to tens of thousands of kilograms.Vibration sensorThe force of the elastic element, the natural vibration frequency of the force is proportional to the square root of. Measure the natural frequency changes, you can find the measured object role in the elastic component of the force, and then calculate the quality. The vibration sensor vibrating wire and tuning fork.The elastic component of the vibrating wire sensor string wire. When the load-bearing stage, plus the measured object, the intersection of the V-shaped string wire is pulled down, and left strings of tension increases, the right string tension decreases. The natural frequency of the two strings of different changes. Calculate the frequency difference between the two strings, you can find the quality of the measured object. The higher the accuracy of the vibrating wire sensor, up to 1/1000 ~ 1/10000, weighing 100 g to hundreds of kilograms, but the structure is complex anddifficult process, and high cost.The elastic component of the tuning fork sensor is a tuning fork. Fixed tuning fork end of the piezoelectric element, the natural frequency of oscillation of a tuning fork, it can be measured oscillation frequency. When the load-bearing stage and the measured object, the tuning fork direction of tensile force while the increase in natural frequency, increasing levels of applied force is proportional to the square root. Measure the changes of natural frequency can be calculated heavy loads imposed on the tuning fork on the force, and then calculate the quality of heavy objects. The tuning fork sensor power consumption, measurement accuracy up to 1/10000 to 1/200 000, weighing range of 500g ~ 10kg.外文参考文献中文翻译参考资料二：摘要: 为解决现代商业贸易和日常生活中经常遇到的测量小质量物体的重量问题, 介绍了一种新型的袖珍式电子秤的设计。
生物科学论文中英文资料外文翻译文献
生物科学论文中英文资料外文翻译文献Carotenoid Biosynthetic Pathway in the Citrus Genus: Number of Copies and Phylogenetic Diversity of Seven GeneThe first objective of this paper was to analyze the potential role of allelic variability of carotenoid biosynthetic genes in the interspecifi diversity in carotenoid composition of Citrus juices. The second objective was to determine the number of copies for each of these genes. Seven carotenoid biosynthetic genes were analyzed using restriction fragment length polymorphism (RFLP) and simple sequence repeats (SSR) markers. RFLP analyses were performed with the genomic DNA obtained from 25 Citrus genotypes using several restriction enzymes. cDNA fragments of Psy, Pds, Zds, Lcyb, Lcy-e, Hy-b, and Zep genes labeled with [R-32P]dCTP were used as probes. For SSR analyses, two primer pairs amplifying two SSR sequences identified from expressed sequence tags (ESTs) of Lcy-b and Hy-b genes were designed. The number of copies of the seven genes ranged from one for Lcy-b to three for Zds. The genetic diversity revealed by RFLP and SSR profiles was in agreement with the genetic diversity obtained from neutral molecμLar markers. Genetic interpretation of RFLP and SSR profiles of four genes (Psy1, Pds1, Lcy-b, and Lcy-e1) enabled us to make inferences on the phylogenetic origin of alleles for the major commercial citrus species. Moreover, the resμLts of our analyses suggest that the allelic diversity observed at the locus of both of lycopene cyclase genes, Lcy-b and Lcy-e1, is associated with interspecific diversity in carotenoid accumμLation in Citrus. The interspecific differences in carotenoid contents previously reported to be associated withother key steps catalyzed by PSY, HY-b, and ZEP were not linked to specific alleles at the corresponding loci.KEYWORDS: Citrus; carotenoids; biosynthetic genes; allelic variability; phylogeny INTRODUCTIONCarotenoids are pigments common to all photosynthetic organisms. In pigment-protein complexes, they act as light sensors for photosynthesis but also prevent photo-oxidat ion induced by too strong light intensities. In horticμLtural crops, they play a major role in fruit, root, or tuber coloration and in nutritional quality. Indeed some of these micronutrients are precursors of vitamin A, an essential component of human and animal diets. Carotenoids may also play a role in chronic disease prevention (such as certain cancers), probably due to their antioxidant properties. The carotenoid biosynthetic pathway is now well established. Carotenoids are synthesized in plastids by nuclear-encoded enzymes. The immediate precursor of carotenoids (and also of gibberellins, plastoquinone, chlorophylls,phylloquinones, and tocopherols) is geranylgeranyl diphosphate (GGPP). In light-grown plants, GGPP is mainly derivedcarotenoid, 15-cis-phytoene. Phytoene undergoes four desaturation reactions catalyzed by two enzymes, phytoene desaturase (PDS) and β-carotene desaturase (ZDS), which convert phytoene into the red-colored poly-cis-lycopene. Recently, Isaacson et al. and Park et al. isolated from tomato and Arabidopsis thaliana, respectively, the genes that encode the carotenoid isomerase (CRTISO) which, in turn, catalyzes the isomerization of poly-cis-carotenoids into all-trans-carotenoids. CRTISO acts on prolycopene to form all-trans lycopene, which undergoes cyclization reactions. Cyclization of lycopene is abranching point: one branch leads to β-carotene (β, β-carotene) and the other toα-carotene (β, ε-carotene). Lycopene β-cyclase (LCY-b) then converts lycopene intoβ-carotene in two steps, whereas the formation of α-carotene requires the action of two enzymes, lycopene ε- cyclase (LCY-e) and lycopene β-cyclase (LCY-b). α- carotene is converted into lutein by hydroxylations catalyzed by ε-carotene hydroxylase (HY-e) andβ-carotene hydroxylase (HY-b). Other xanthophylls are produced fromβ-carotene with hydroxylation reactions catalyzed by HY-b and epoxydation catalyzed by zeaxanthin epoxidase (ZEP). Most of the carotenoid biosynthetic genes have been cloned and sequenced in Citrus varieties . However, our knowledge of the complex regμLation of carotenoid biosynthesis in Citrus fruit is still limited. We need further information on the number of copies of these genes and on their allelic diversity in Citrus because these can influence carotenoid composition within the Citrus genus.Citrus fruit are among the richest sources of carotenoids. The fruit generally display a complex carotenoid structure, and 115 different carotenoids have been identified in Citrus fruit. The carotenoid richness of Citrus flesh depends on environmental conditions, particμLarly on growing conditions and on geogr aphical origin . However the main factor influencing variability of caro tenoid quality in juice has been shown to be genetic diversity. Kato et al. showed that mandarin and orange juices accumμLated high levels of β-cryptoxanthin and violaxanthin, respectively, whereas mature lemon accumμLated extremely low levels of carotenoids. Goodner et al. demonstrated that mandarins, oranges, and their hybrids coμLd be clearly distinguished by theirβ-cryptoxanthin contents. Juices of red grapefruit contained two major carotenoids: lycopene and β-carotene. More recently, we conducted a broad study on the organization of the variability of carotenoid contents in different cμLtivated Citrus species in relation with the biosynthetic pathway . Qualitative analysis of presence or absence of the different compounds revealed three main clusters: (1) mandarins, sweet oranges, and sour oranges;(2) citrons, lemons, and limes; (3) pummelos and grapefruit. Our study also enabled identification of key steps in the diversification of the carotenoid profile. Synthesis of phytoene appeared as a limiti ng step for acid Citrus, while formation of β-carotene and R-carotene from lycopene were dramatically limited in cluster 3 (pummelos and grapefruit). Only varieties in cluster 1 were able to produce violaxanthin. In the same study , we concluded that there was a very strong correlation between the classification of Citrus species based on the presence or absence of carotenoids (below,this classification is also referred to as the organization of carotenoid diversity) and genetic diversity evaluated with bi ochemical or molecμLar markers such as isozymes or randomLy amplified polymorphic DNA (RAPD). We also concluded that, at the interspecific level, the organization of the diversity of carotenoid composition was linked to the global evolution process of cμLt ivated Citrus rather than to more recent mutation events or human selection processes. Indeed, at interspecific level, a correlation between phenotypic variability and genetic diversity is common and is generally associated with generalized gametic is common and is generally associated with generalized gametic disequilibrium resμLting from the history of cμLtivated Citrus. Thus from numerical taxonomy based on morphologicaltraits or from analysis of molecμLar markers , all authors agreed on the existence o f three basic taxa (C. reticμLata, mandarins; C. medica, citrons; and C. maxima, pummelos) whose differentiation was the resμLt of allopatric evolution. All other cμLtivated Citrus specie s (C. sinensis, sweet oranges; C. aurantium, sour oranges;C. paradi si, grapefruit; and C. limon, lemons) resμLted from hybridization events within this basic pool except for C. aurantifolia, which may be a hybrid between C. medica and C. micrantha .Our p revious resμLts and data on Citrus evolution lead us to propose the hypothesis that the allelic variability supporting the organization of carotenoid diversity at interspecific level preceded events that resμLted in the creation of secondary species. Such molecμLar variability may have two different effects: on the one hand, non-silent substitutions in coding region affect the specific activity of corresponding enzymes of the biosynthetic pathway, and on the other hand, variations in untranslated regions affect transcriptional or post-transcriptional mechanisms.There is no available data on the allelic diversity of Citrus genes of the carotenoid biosynthetic pathway. The objective of this paper was to test the hypothesis that allelic variability of these genes partially determines phenotypic variability at the interspecific level. For this purpose, we analyzed the RFLPs around seven genes of the biosynthetic pathway of carotenoids (Psy, Pds, Zds, Lcy-b, Lcy-e, Hy-b, Zep) and the polymorphism of two SSR sequences found in Lcy-b and Hy-b genes in a representative set of varieties of the Citrus genus already analyzed for carotenoid constitution. Our study aimed to answer the following questions: (a) are those genes mono- or mμLtilocus, (b) is the polymorphism revealed by RFLP and SSR markers inagreement with the general histor y of cμLtivated Citrus thus permitting inferences about the phylogenetic origin of genes of the secondary species, and (c) is this polymorphism associated with phenotypic (carotenoid compound) variations.RESΜLTS AND DISCUSSIONGlobal Diversity of the Genotype Sample Observed by RFLP Analysis. RFLP analyses were performed using probes defined from expressed sequences of seven major genes of the carotenoid biosynthetic pathway . One or two restriction enzymes were used for each gene. None of these enzymes cut the cDNA probe sequence except HindIII for the Lcy-e gene. Intronic sequences and restriction sites on genomic sequences werescreened with PCR amplification using genomic DNA as template and with digestion of PCR products. The resμLts indicated the absence of an intronic sequence for Psy and Lcy-b fragments. The absence of intron in these two fragments was checked by cloning and sequencing corresponding genomic sequences (data not shown). Conversely, we found introns in Pds, Zds, Hy-b, Zep, and Lcy-e genomic sequences corresponding to RFLP probes. EcoRV did not cut the genomic sequences of Pds, Zds, Hy-b, Zep, and Lcy-e. In the same way, no BamHI restriction site was found in the genomic sequences of Pds, Zds, and Hy-b. Data relative to the diversity observed for the different genes are presented in Table 4. A total of 58 fragments were identified, six of them being monomorphic (present in all individuals). In the limited sample of the three basic taxa, only eight bands out of 58 coμLd not be observed. In the basic taxa, the mean number of bands per genotype observed was 24.7, 24.7, and 17 for C. reticμLata, C. maxima, and C. medica, respectively. It varies from28 (C. limettioides) to 36 (C. aurantium) for the secondary species. The mean number of RFLP bands per individual was lower for basic taxa than for the group of secondary species. This resμLt indicates that secondary species are much more heterozygous than the basic ones for these genes, which is logical if we assume that the secondary species arise from hybridizations between the three basic taxa. Moreover C. medica appears to be the least heterozygous taxon for RFLP around the genes of the carotenoid biosynthetic pathway, as already shown with isozymes, RAPD, and SSR markers.The two lemons were close to the acid Citrus cluster and the three sour oranges close to the mandarins/sweet oranges cluster. This organization of genetic diversity based on the RFLP profiles obtained with seven genes of the carotenoid pathway is very similar to that previously obtained with neutral molecμLar markers such as genomic SSR as well as the organization obtained with qualitative carotenoid compositions. All these resμLts suggest that the observed RFLP and SSR fragments are good phylogenetic markers. It seems consistent with our basic hypothesis that major differentiation in the genes involved in the carotenoid biosynthetic pathway preceded the creation of the secondary hybrid species and thus that the allelic structure of these hybrid species can be reconstructed from alleles observed in the three basic taxa.Gene by Gene Analysis: The Psy Gene. For the Psy probe combined with EcoRV or BamHI restriction enzymes, five bands were identified for the two enzymes, and two to three bands were observed for each genotype. One of these bands was present in all individuals. There was no restriction site in the probe sequence. These resμLts lead us to believe that Psy is present at two loci,one where no polymorphism was found with the restriction enzymes used, and one that displayed polymorphism. The number of different profiles observed was six and four with EcoRV and BamHI, respectively, for a total of 10 different profiles among the 25 individuals .Two Psy genes have also been found in tomato, tobacco, maize, and rice . Conversely, only one Psy gene has been found in Arabidopsis thaliana and in pepper (Capsicum annuum), which also accumμLates carotenoids in fruit. According to Bartley and Scolnik, Psy1 was expressed in tomato fruit chromoplasts, while Psy2 was specific to leaf tissue. In the same way, in Poaceae (maize, rice), Gallagher et al. found that Psy gene was duplicated and that Psy1 and notPsy2 transcripts in endosperm correlated with endosperm carotenoid accumμLation. These resμLts underline the role of gene duplication and the importance of tissue-specific phytoene synthase in the regμLation of carotenoid accumμLation.All the polymorphic bands were present in the sample of the basic taxon genomes. Assuming the hypothesis that all these bands describe the polymorphism at the same locus for the Psy gene, we can conclude that we found allelic differentiation between the three basic taxa with three alleles for C. reticμLata, four for C. maxima, and one for C. medica.The alleles observed for the basic taxa then enabled us to determine the genotypes of all the other species. The presumed genotypes for the Psy polymorphic locus are given in Table 7. Sweet oranges and grapefruit were heterozygous with one mandarin and one pummelo allele. Sour oranges were heterozygous; they shared the same mandarin allele with sweet oranges but had a different pummelo allele. Clementine was heterozygous with two mandarin alleles; one shared with sweetoranges and one with “Willow leaf” mandarin. “Meyer” lemon was heterozygous, with the mandarin allele also found in sweet oranges, and the citron allele. “Eureka”lemon was also heterozygous with the same pummelo allele as sour oranges and the citron allele. The other acid Citrus were homozygous for the citron allele.The Pds Gen. For the Pds probe combined with EcoRV, six different fragments were observed. One was common to all individuals. The number of fragments per individual was two or three. ResμLts for Pds led us to believe that this gene is present at two loci, one where no polymorphism was found with EcoRV restriction, and one displaying polymorphism. Conversely, studies on Arabidopsis, tomato, maize, and rice showed that Pds was a single copy gene. However, a previous study on Citrus suggests that Pds is present as a low-copy gene family in the Citrus genome, which is in agreement with our findings.The Zds Gene. The Zds profiles were complex. Nine and five fragments were observed with EcoRV and BamHI restriction, respectively. For both enzymes, one fragment was common to all individuals. The number of fragments per individual ranged from two to six for EcoRV and three to five for BamHI. There was no restriction site in the probe sequence. It can be assumed that several copies (at least three) of the Zds gene are present in the Citrus genome with polymorphism for at least two of them. In Arabidopsis, maize, and rice, like Pds, Zds was a single-copy gene .In these conditions and in the absence of analysis of controlled progenies, we are unable to conduct genetic analysis of profiles. However it appears that some bands differentiated the basic taxa: one for mandarins, one for pummelos, and one for citrons with EcoRV restriction and one for pummelos and onefor citrons with BamHI restriction. Two bands out of the nine obtained with EcoRV were not observed in the samples of basic taxa. One was rare and only observed in “Rangpur” lime. The other was found in sour oranges, “V olkamer” lemon,and “Palestine sweet” lime suggesting a common ancestor for these three genotypes.This is in agreement with the assumption of Nicolosi et al. that “V olkamer” lemon resμLts from a complex hybrid combination with C. aurantium as one parent. It will be necessary to extend the analysis of the basic taxa to conclude whether these specific bands are present in the diversity of these taxa or resμLt from mutations after the formation of the secondary species.The Lcy-b Gene with RFLP Analysis.After restriction with EcoRV and hybridization with the Lcy-b probe, we obtained simple profiles with a total of four fragments. One to two fragments were observed for each individual, and seven profiles were differentiated among the 25 genotypes. These resμLts provide evidence that Lcy-b is present at a single locus in the haploid Citrus genome. Two lycopene β-cyclases encoded by two genes have been identified in tomato. The B gene encoded a novel type of lycopene β-cyclase whose sequence was similar to capsanthin-capsorubin synthase. The B gene expressed at a high level in βmutants was responsible for strong accumμLation ofβ-carotene in fruit, while in wild-type tomatoes, B was expressed at a low level.The Lcy-b Gene with SSR Analysis. Four bands were detected at locus 1210 (Lcy-b gene). One or two bands were detected per variety confirming that this gene is mono locus. Six different profiles were observed among the 25 genotypes. As with RFLPanalysis, no intrataxon molecμLar polymorphism was found within C. Paradisi, C. Sinensis, and C. Aurantium.Taken together, the information obtained from RFLP and SSR analyses enabled us to identify a complete differentiation among the three basic taxon samples. Each of these taxons displayed two alleles for the analyzed sample. An additional allele was identified for “Mexican” l ime. The profiles for all secondary species can be reconstructed from these alleles. Deduced genetic structure is given in. Sweet oranges and clementine were heterozygous with one mandarin and one pummelo allele. Sour oranges were also heterozygous sharing the same mandarin allele as sweet oranges but with another pummelo allele. Grapefruit were heterozygous with two pummelo alleles. All the acid secondary species were heterozygous, having one allele from citrons and the other one from mandarins except for “Mexican” lime, which had a specific allele.柑桔属类胡萝卜素生物合成途径中七个基因拷贝数目及遗传多样性的分析摘要：本文的首要目标是分析类胡萝卜素生物合成相关等位基因在发生变异柑橘属类胡萝卜素组分种间差异的潜在作用；第二个目标是确定这些基因的拷贝数。
智能控制系统毕业论文中英文资料对照外文翻译文献
智能控制系统中英文资料对照外文翻译文献附录一：外文摘要The development and application of Intelligence controlsystemModern electronic products change rapidly is increasingly profound impact on people's lives, to people's life and working way to bring more convenience to our daily lives, all aspects of electronic products in the shadow, single chip as one of the most important applications, in many ways it has the inestimable role. Intelligent control is a single chip, intelligent control of applications and prospects are very broad, the use of modern technology tools to develop an intelligent, relatively complete functional software to achieve intelligent control system has become an imminent task. Especially in today with MCU based intelligent control technology in the era, to establish their own practical control system has a far-reaching significance so well on the subject later more fully understanding of SCM are of great help to.The so-called intelligent monitoring technology is that:" the automatic analysis and processing of the information of the monitored device". If the monitored object as one's field of vision, and intelligent monitoring equipment can be regarded as the human brain. Intelligent monitoring with the aid of computer data processing capacity of the powerful, to get information in the mass data to carry on the analysis, some filtering of irrelevant information, only provide some key information. Intelligent control to digital, intelligent basis, timely detection system in the abnormal condition, and can be the fastest and best way to sound the alarm and provide usefulinformation, which can more effectively assist the security personnel to deal with the crisis, and minimize the damage and loss, it has great practical significance, some risk homework, or artificial unable to complete the operation, can be used to realize intelligent device, which solves a lot of artificial can not solve the problem, I think, with the development of the society, intelligent load in all aspects of social life play an important reuse.Single chip microcomputer as the core of control and monitoring systems, the system structure, design thought, design method and the traditional control system has essential distinction. In the traditional control or monitoring system, control or monitoring parameters of circuit, through the mechanical device directly to the monitored parameters to regulate and control, in the single-chip microcomputer as the core of the control system, the control parameters and controlled parameters are not directly change, but the control parameter is transformed into a digital signal input to the microcontroller, the microcontroller according to its output signal to control the controlled object, as intelligent load monitoring test, is the use of single-chip I / O port output signal of relay control, then the load to control or monitor, thus similar to any one single chip control system structure, often simplified to input part, an output part and an electronic control unit ( ECU )Intelligent monitoring system design principle function as follows: the power supply module is 0~220V AC voltage into a0 ~ 5V DC low voltage, as each module to provide normal working voltage, another set of ADC module work limit voltage of 5V, if the input voltage is greater than 5V, it can not work normally ( but the design is provided for the load voltage in the 0~ 5V, so it will not be considered ), at the same time transformer on load current is sampled on the accused, the load current into a voltage signal, and then through the current - voltage conversion, and passes through the bridge rectification into stable voltage value, will realize the load the current value is converted to a single chip can handle0 ~ 5V voltage value, then the D2diode cutoff, power supply module only plays the role of power supply. Signal to the analog-to-digital conversion module, through quantization, coding, the analog voltage value into8bits of the digital voltage value, repeatedly to the analog voltage16AD conversion, and the16the digital voltage value and, to calculate the average value, the average value through a data bus to send AT89C51P0, accepted AT89C51 read, AT89C51will read the digital signal and software setting load normal working voltage reference range [VMIN, VMAX] compared with the reference voltage range, if not consistent, then the P1.0 output low level, close the relay, cut off the load on the fault source, to stop its sampling, while P1.1 output high level fault light, i.e., P1.3 output low level, namely normal lights. The relay is disconnected after about 2minutes, theAT89C51P1.0outputs high level ( software design), automatic closing relay, then to load the current regular sampling, AD conversion, to accept the AT89C51read, comparison, if consistent, then the P1.1 output low level, namely fault lights out, while P1.3 output high level, i.e. normal lamp ( software set ); if you are still inconsistent, then the need to manually switch S1toss to" repair" the slip, disconnect the relay control, load adjusting the resistance value is: the load detection and repair, and then close the S1repeatedly to the load current sampling, until the normal lamp bright, repeated this process, constantly on the load testing to ensure the load problems timely repair, make it work.In the intelligent load monitoring system, using the monolithic integrated circuit to the load ( voltage too high or too small ) intelligent detection and control, is achieved by controlling the relay and transformer sampling to achieve, in fact direct control of single-chip is the working state of the relay and the alarm circuit working state, the system should achieve technical features of this thesis are as follows (1) according to the load current changes to control relays, the control parameter is the load current, is the control parameter is the relay switch on-off and led the state; (2) the set current reference voltage range ( load normal working voltage range ), by AT89C51 chip the design of the software section, provide a basis for comparison; (3) the use of single-chip microcomputer to control the light-emitting diode to display the current state of change ( normal / fault / repair ); specific summary: Transformer on load current is sampled, a current / voltage converter, filter, regulator, through the analog-digital conversion, to accept the AT89C51chip to read, AT89C51 to read data is compared with the reference voltage, if normal, the normal light, the output port P.0high level, the relay is closed, is provided to the load voltage fault light; otherwise, P1.0 output low level, The disconnecting relay to disconnect the load, the voltage on the sampling, stop. Two minutes after closing relay, timing sampling.System through the expansion of improved, can be used for temperature alarm circuit, alarm circuit, traffic monitoring, can also be used to monitor a system works, in the intelligent high-speed development today, the use of modern technology tools, the development of an intelligent, function relatively complete software to realize intelligent control system, has become an imminent task, establish their own practical control system has a far-reaching significance. Micro controller in the industry design and application, no industry like intelligent automation and control field develop so fast. Since China and the Asian region the main manufacturing plant intelligence to improve the degree of automation, new technology to improve efficiency, have important influence on the product cost. Although the centralized control can be improved in any particular manufacturing process of the overall visual, but not for those response and processingdelay caused by fault of some key application.Intelligent control technology as computer technology is an important technology, widely used in industrial control, intelligent control, instrument, household appliances, electronic toys and other fields, it has small, multiple functions, low price, convenient use, the advantages of a flexible system design. Therefore, more and more engineering staff of all ages, so this graduate design is of great significance to the design of various things, I have great interest in design, this has brought me a lot of things, let me from unsuspectingly to have a clear train of thought, since both design something, I will be there a how to design thinking, this is very important, I think this job will give me a lot of valuable things.中文翻译：智能控制系统的开发应用现代社会电子产品日新月异正在越来越深远的影响着人们的生活，给人们的生活和工作方式带来越来越大的方便，我们的日常生活各个方面都有电子产品的影子，单片机作为其中一个最重要的应用，在很多方面都有着不可估量的作用。
毕业论文文献外文翻译----危机管理：预防,诊断和干预文献翻译-中英文文献对照翻译
第1页 共19页中文3572字毕业论文（设计）外文翻译标题：危机管理-预防，诊断和干预一、外文原文标题：标题：Crisis management: prevention, diagnosis and Crisis management: prevention, diagnosis andintervention 原文：原文：The Thepremise of this paper is that crises can be managed much more effectively if the company prepares for them. Therefore, the paper shall review some recent crises, theway they were dealt with, and what can be learned from them. Later, we shall deal with the anatomy of a crisis by looking at some symptoms, and lastly discuss the stages of a crisis andrecommend methods for prevention and intervention. Crisis acknowledgmentAlthough many business leaders will acknowledge thatcrises are a given for virtually every business firm, many of these firms do not take productive steps to address crisis situations. As one survey of Chief Executive officers of Fortune 500 companies discovered, 85 percent said that a crisisin business is inevitable, but only 50 percent of these had taken any productive action in preparing a crisis plan(Augustine, 1995). Companies generally go to great lengths to plan their financial growth and success. But when it comes to crisis management, they often fail to think and prepare for those eventualities that may lead to a company’s total failure.Safety violations, plants in need of repairs, union contracts, management succession, and choosing a brand name, etc. can become crises for which many companies fail to be prepared untilit is too late.The tendency, in general, is to look at the company as a perpetual entity that requires plans for growth. Ignoring the probabilities of disaster is not going to eliminate or delay their occurrences. Strategic planning without inclusion ofcrisis management is like sustaining life without guaranteeinglife. One reason so many companies fail to take steps to proactively plan for crisis events, is that they fail to acknowledge the possibility of a disaster occurring. Like an ostrich with its head in the sand, they simply choose to ignorethe situation, with the hope that by not talking about it, it will not come to pass. Hal Walker, a management consultant, points out “that decisions will be more rational and better received, and the crisis will be of shorter duration, forcompanies who prepare a proactive crisis plan” (Maynard, 1993) .It is said that “there are two kinds of crises: those that thatyou manage, and those that manage you” (Augustine, 1995). Proactive planning helps managers to control and resolve a crisis. Ignoring the possibility of a crisis, on the other hand,could lead to the crisis taking a life of its own. In 1979, theThree-Mile Island nuclear power plant experienced a crisis whenwarning signals indicated nuclear reactors were at risk of a meltdown. The system was equipped with a hundred or more different alarms and they all went off. But for those who shouldhave taken the necessary steps to resolve the situation, therewere no planned instructions as to what should be done first. Hence, the crisis was not acknowledged in the beginning and itbecame a chronic event.In June 1997, Nike faced a crisis for which they had no existi existing frame of reference. A new design on the company’s ng frame of reference. A new design on the company’s Summer Hoop line of basketball shoes - with the word air writtenin flaming letters - had sparked a protest by Muslims, who complained the logo resembled the Arabic word for Allah, or God.The council of American-Islamic Relations threatened aa globalNike boycott. Nike apologized, recalled 38,000 pairs of shoes,and discontinued the line (Brindley, 1997). To create the brand,Nike had spent a considerable amount of time and money, but hadnever put together a general framework or policy to deal with such controversies. To their dismay, and financial loss, Nike officials had no choice but to react to the crisis. This incident has definitely signaled to the company that spending a little more time would have prevented the crisis. Nonetheless,it has taught the company a lesson in strategic crisis management planning.In a business organization, symptoms or signals can alert the strategic planners or executives of an eminent crisis. Slipping market share, losing strategic synergy anddiminishing productivity per man hour, as well as trends, issues and developments in the socio-economic, political and competitive environments, can signal crises, the effects of which can be very detrimental. After all, business failures and bankruptcies are not intended. They do not usually happen overnight. They occur more because of the lack of attention to symptoms than any other factor.Stages of a crisisMost crises do not occur suddenly. The signals can usuallybe picked up and the symptoms checked as they emerge. A company determined to address these issues realizes that the real challenge is not just to recognize crises, but to recognize themin a timely fashion (Darling et al., 1996). A crisis can consistof four different and distinct stages (Fink, 1986). The phasesare: prodromal crisis stage, acute crisis stage, chronic crisisstage and crisis resolution stage.Modern organizations are often called “organic” due tothe fact that they are not immune from the elements of their surrounding environments. Very much like a living organism, organizations can be affected by environmental factors both positively and negatively. But today’s successfulorganizations are characterized by the ability to adapt by recognizing important environmental factors, analyzing them, evaluating the impacts and reacting to them. The art of strategic planning (as it relates to crisis management)involves all of the above activities. The right strategy, in general, provides for preventive measures, and treatment or resolution efforts both proactively and reactively. It wouldbe quite appropriate to examine the first three stages of acrisis before taking up the treatment, resolution or intervention stage.Prodromal crisis stageIn the field of medicine, a prodrome is a symptom of the onset of a disease. It gives a warning signal. In business organizations, the warning lights are always blinking. No matter how successful the organization, a number of issues andtrends may concern the business if proper and timely attentionis paid to them. For example, in 1995, Baring Bank, a UK financial institution which had been in existence since 1763,ample opportunitysuddenly and unexpectedly failed. There wasfor the bank to catch the signals that something bad was on thehorizon, but the company’s efforts to detect that were thwarted by an internal structure that allowed a single employee both to conduct and to oversee his own investment trades, and the breakdown of management oversight and internalcontrol systems (Mitroff et al., 1996). Likewise, looking in retrospect, McDonald’s fast food chain was given the prodromalsymptoms before the elderly lady sued them for the spilling ofa very hot cup of coffee on her lap - an event that resulted in a substantial financial loss and tarnished image of thecompany. Numerous consumers had complained about thetemperature of the coffee. The warning light was on, but the company did not pay attention. It would have been much simplerto pick up the signal, or to check the symptom, than facing the consequences.In another case, Jack in the Box, a fast food chain, had several customers suffer intestinal distress after eating at their restaurants. The prodromal symptom was there, but the company took evasive action. Their initial approach was to lookaround for someone to blame. The lack of attention, the evasiveness and the carelessness angered all the constituent groups, including their customers. The unfortunate deaths thatptoms,occurred as a result of the company’s ignoring thesymand the financial losses that followed, caused the company to realize that it would have been easier to manage the crisis directly in the prodromal stage rather than trying to shift theblame.Acute crisis stageA prodromal stage may be oblique and hard to detect. The examples given above, are obvious prodromal, but no action wasWebster’s New Collegiate Dictionary, an acute stage occursacutewhen a symptom “demands urgent attention.” Whether the acutesymptom emerges suddenly or is a transformation of a prodromalstage, an immediate action is required. Diverting funds and other resources to this emerging situation may cause disequilibrium and disturbance in the whole system. It is onlythose organizations that have already prepared a framework forthese crises that can sustain their normal operations. For example, the US public roads and bridges have for a long time reflected a prodromal stage of crisis awareness by showing cracks and occasionally a collapse. It is perhaps in light of the obsessive decision to balance the Federal budget that reacting to the problem has been delayed and ignored. This situation has entered an acute stage and at the time of this writing, it was reported that a bridge in Maryland had just collapsed.The reason why prodromes are so important to catch is thatit is much easier to manage a crisis in this stage. In the caseof most crises, it is much easier and more reliable to take careof the problem before it becomes acute, before it erupts and causes possible complications (Darling et al., 1996). In andamage. However, the losses are incurred. Intel, the largest producer of computer chips in the USA, had to pay an expensiveprice for initially refusing to recall computer chips that proved unreliable o n on certain calculations. The f irmfirm attempted to play the issue down and later learned its lesson. At an acutestage, when accusations were made that the Pentium Chips were not as fast as they claimed, Intel quickly admitted the problem,apologized for it, and set about fixing it (Mitroff et al., 1996). Chronic crisis stageDuring this stage, the symptoms are quite evident and always present. I t isIt is a period of “make or break.” Being the third stage, chronic problems may prompt the company’s management to once and for all do something about the situation. It may be the beginning of recovery for some firms, and a deathknell for others. For example, the Chrysler Corporation was only marginallysuccessful throughout the 1970s. It was not, however, until the company was nearly bankrupt that amanagement shake-out occurred. The drawback at the chronic stage is that, like in a human patient, the company may get used to “quick fixes” and “band “band--aid”approaches. After all, the ailment, the problem and the crisis have become an integral partoverwhelmed by prodromal and acute problems that no time or attention is paid to the chronic problems, or the managers perceive the situation to be tolerable, thus putting the crisison a back burner.Crisis resolutionCrises could be detected at various stages of their development. Since the existing symptoms may be related todifferent problems or crises, there is a great possibility thatthey may be misinterpreted. Therefore, the people in charge maybelieve they have resolved the problem. However, in practicethe symptom is often neglected. In such situations, the symptomwill offer another chance for resolution when it becomes acute,thereby demanding urgent care. Studies indicate that today anincreasing number of companies are issue-oriented and searchfor symptoms. Nevertheless, the lack of experience in resolvinga situation and/or inappropriate handling of a crisis can leadto a chronic stage. Of course, there is this last opportunityto resolve the crisis at the chronic stage. No attempt to resolve the crisis, or improper resolution, can lead to grim consequences that will ultimately plague the organization or even destroy it.It must be noted that an unsolved crisis may not destroy the company. But, its weakening effects can ripple through the organization and create a host of other complications.Preventive effortsThe heart of the resolution of a crisis is in the preventiveefforts the company has initiated. This step, similar to a humanbody, is actually the least expensive, but quite often the mostoverlooked. Preventive measures deal with sensing potential problems (Gonzales-Herrero and Pratt, 1995). Major internalfunctions of a company such as finance, production, procurement, operations, marketing and human resources are sensitive to thesocio-economic, political-legal, competitive, technological, demographic, global and ethical factors of the external environment. What is imminently more sensible and much more manageable, is to identify the processes necessary forassessing and dealing with future crises as they arise (Jacksonand Schantz, 1993). At the core of this process are appropriate information systems, planning procedures, anddecision-making techniques. A soundly-based information system will scan the environment, gather appropriate data, interpret this data into opportunities and challenges, and provide a concretefoundation for strategies that could function as much to avoid crises as to intervene and resolve them.Preventive efforts, as stated before, require preparations before any crisis symptoms set in. Generally strategic forecasting, contingency planning, issues analysis, and scenario analysis help to provide a framework that could be used in avoiding and encountering crises.出处：出处：Toby TobyJ. Kash and John R. Darling . Crisis management: prevention, diagnosis 179-186二、翻译文章标题：危机管理：预防，诊断和干预译文：本文的前提是，如果该公司做好准备得话，危机可以更有效地进行管理。
BS EN ISO 15197：2015 体外诊断检验系统-糖尿病管理中自测用血糖监测系统的要求(英文版)
BS EN ISO 15197:2015In vitro diagnostic test systems — Requirements for blood-glucose monitoring systemsfor self-testing in managing diabetes mellitusBS EN ISO 15197:2015BRITISH STANDARDNational forewordThis British Standard is the UK implementation ofEN ISO15197:2015.It is identical to ISO 15197:2013. Itsupersedes BS EN ISO 15197:2013which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication.© The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 90800 2ICS 11.040.55; 11.100.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORMEN ISO 15197 June2015ICS 11.100.10Supersedes EN ISO 15197:2013English VersionIn vitro diagnostic test systems - Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus(ISO 15197:2013)Systèmes d'essais de diagnostic in vitro - Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré (ISO15197:2013) Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung bei Diabetesmellitus (ISO 15197:2013)This European Standard was approved by CEN on 3 June 2015.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONC O M I TÉ E U R OPÉE NDE N O R M A LI S A T I O NEUR O PÄIS C HES KOM I TE E FÜR NOR M UNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels© 2015 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15197:2015 EBS EN ISO 15197:2015EN ISO 15197:2015 (E)ForewordThe text of ISO 15197:2013 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 15197:2015 by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by June 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 15197:2013.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex ZA’, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.BS EN ISO 15197:2015 EN ISO 15197:2015 (E)Table — Correlation between undated normative references and dated EN and ISO standardsNormative references as listedin Clause 2Equivalent dated standardEN ISOISO 13485 EN ISO 13485:2012 + AC:2012 ISO 13485:2003 + Cor. 1:2009ISO 14971 EN ISO 14971:2012 ISO 14971:2007, Corrected version2007-10-01ISO 17511 EN ISO 17511:2003 ISO 17511:2003ISO 18113-1 EN ISO 18113-1:2011 ISO 18113-1:2009ISO 18113-4 EN ISO 18113-4:2011 ISO 18113-4:2009ISO 18113-5 EN ISO 18113-5:2011 ISO 18113-5:2009ISO 23640 EN ISO 23640:2014 ISO 23640:2011IEC 60068-2-64 EN 60068-2-64:2008 IEC 60068-2-64:2008IEC 61010-1 EN 61010-1:2010 IEC 61010-1:2010 + Cor. :2011IEC 61010-2-101 EN 61010-2-101:2002 IEC 61010-2-101:2002IEC 61326-1 EN 61326-1:2013 IEC 61326-1:2012IEC 61326-2-6 EN 61326-2-6:2013 IEC 61326-2-6:2012IEC 62366 EN 62366:2008 IEC 62366:2007EN 13612 EN 13612:2002According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 15197:2013 has been approved by CEN as EN ISO 15197:2015 without any modification.BS EN ISO 15197:2015EN ISO 15197:2015 (E)Annex ZA(informative)Relationship between this European Standard and the EssentialRequirements of EU Directive 98/79/ECThis European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of Directive 98/79/EC in vitro diagnostic medical devices.Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA Regulations.NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential requirement.NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text.NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.Table ZA.1 — Correspondence between this European Standard and Directive 98/79/ECClause(s)/sub-clause(s) of this EN Essential Requirements(ERs) ofDirective 98/79/ECQualifying remarks/notes4.3 A.2 Referenced clause covers only the firstbullet point of the ER.Risk management of blood glucosemonitoring instrument is not covered bythe referenced clause.Directive 98/79/EC requiresmanufacturers to eliminate or reduce risksas far as possible.For managing risks associated with invitro diagnostic medical devices ENISO 14971:2012 should be applied.5.11, 5.12 B.3.3 Referenced clauses cover only thetemperature (5.11) and humidity (5.12)aspects of the ER (in second bullet)4.4 B.3.66, 7.2 B.4.1 This ER is covered when accuracy limitsare stated by the manufacturer in the IFU.4.5 B.7.2WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.BS EN ISO 15197:2015ISO 15197:2013(E) Contents PageForeword (iv)Introduction (v)1 Scope (1)2 Normative references (1)3 Terms and definitions (2)4 Design and development (8)4.1 General requirements (8)4.2 Metrological traceability (8)4.3 Safety and risk management (9)4.4 Ergonomics and human factors (10)4.5 User verification requirements (10)5 Safety and reliability testing (10)5.1 General requirements (10)5.2 Protection against electric shock (11)5.3 Protection against mechanical hazards (11)5.4 Electromagnetic compatibility (11)5.5 Resistance to heat (11)5.6 Resistance to moisture and liquids (11)5.7 Protection against liberated gases, explosion and implosion (12)5.8 Meter components (12)5.9 Performance test (12)5.10 Mechanical resistance to vibration and shock (12)5.11 Equipment temperature exposure limits for storage (13)5.12 Equipment humidity exposure limits for storage (13)6 Analytical performance evaluation (14)6.1 General requirements (14)6.2 Measurement precision (16)6.3 System accuracy (19)6.4 Influence quantities (25)6.5 Stability of reagents and materials (30)7 Information supplied by the manufacturer (30)7.1 General requirements (30)7.2 Performance characteristics (31)7.3 Options for supplying instructions for use (31)8 User performance evaluation (31)8.1 General requirements (31)8.2 Acceptance criteria and evaluation of results (32)8.3 Selection and preparation of subjects (32)8.4 Execution of study protocol (32)8.5 Glucose reference values (33)8.6 Human factors (33)8.7 Data analysis and presentation of results (33)8.8 Evaluation of instructions for use (34)Annex A (informative) Possible interfering substances (35)Annex B (informative) Traceability chain (36)Annex C (informative) Rationale for the analytical performance requirements (38)Bibliography (45)BS EN ISO 15197:2015ISO 15197:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15197 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first edition (ISO 15197:2003), the clauses, subclauses and annexes of which have been technically revised.BS EN ISO 15197:2015ISO 15197:2013(E) IntroductionBlood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. Diabetes mellitus is caused by a deficiency in insulin secretion or by insulin resistance leading to abnormally high concentrations of glucose in the blood, which may result in acute and chronic health complications. When used properly, a glucose monitoring system allows the user to monitor and take action to control the concentration of glucose present in the blood. This International Standard is intended for blood-glucose monitoring systems used by lay persons. The primary objectives are to establish requirements that result in acceptable performance and to specify procedures for demonstrating conformance to this International Standard. Minimum performance criteria for blood-glucose monitoring systems were established from the analytical requirements (precision and trueness) for individual glucose measurement results. “System accuracy” is the term used in this International Standard to communicate the analytical capability of a blood-glucose monitoring system to the intended users (i.e. lay persons), who would not be familiar with metrological terms commonly used in laboratory medicine. System accuracy describes the ability of a glucose monitoring system to produce measurement results that agree with true glucose values when the system is used as intended. The concept of “system accuracy” includes measurement bias and measurement precision.The requirements for system accuracy are based on three considerations:— the effectiveness of current technology for monitoring patients with diabetes mellitus;— recommendations of diabetes researchers as well as existing product standards and regulatory guidelines; and— the state-of-the-art of blood-glucose monitoring technology.In arriving at the performance requirements specified in the second edition of this International Standard, desirable goals had to be weighed against the capabilities of existing blood-glucose monitoring technology. The revised performance criteria in this edition are the result of improvements in technology since publication of the first edition. The considerations that formed the basis for the minimum acceptable analytical performance of a blood-glucose measuring device intended for self-monitoring are described in Annex C.Requirements that are unique to self-monitoring devices for blood-glucose are addressed in this International Standard. Requirements that apply in general to all in vitro diagnostic medical devices are incorporated by reference to other standards where appropriate.Although this International Standard does not apply to glucose monitoring systems that provide measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures) or medical devices that measure blood-glucose continuously for self-monitoring, it may be useful as a guide for developing procedures to evaluate the performance of such systems.BS EN ISO 15197:2015BS EN ISO 15197:2015 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus1 ScopeThis International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.This International Standard does not:— provide a comprehensive evaluation of all possible factors that could affect the performance of these systems,— pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,— address the medical aspects of diabetes mellitus management,— apply to measurement procedures with measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures), or to continuous glucose monitoring systems,— apply to glucose meters intended for use in medical applications other than self-testing for the management of diabetes mellitus2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes ISO 14971, Medical devices — Application of risk management to medical devices ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materialsISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirementsISO 18113-4, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testingISO 18113-5, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testingISO 23640, In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and guidanceINTERNATIONAL STANDARD ISO 15197:2013(E)© ISO 2013 – All rights reserved 1British Standards InstitutionProvided by IHS under license with BSI - Uncontrolled CopyLicensee=Chongqing Institute of quality and Standardization 5990390Not for Resale, 2015/8/27 08:52:05 No reproduction or networking permitted without license from IHSBS EN ISO 15197:2015 ISO 15197:2013(E)IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1: General requirementsIEC 61010-2-101, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmentIEC 61326-1, Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirementsIEC 61326-2-6, Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipmentIEC 62366, Medical devices — Application of usability engineering to medical devices EN 13612, Performance evaluation of in vitro diagnostic medical devices 3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18113-1 and the following apply.3.1blood-glucose monitoring system measuring system consisting of a portable instrument and reagents used for the in vitro monitoring of glucose concentrations in blood Note 1 to entry: Blood-glucose monitoring systems measure glucose in capillary blood samples, but can express measured values as either the glucose concentration in capillary blood or the equivalent glucose concentration in capillary plasma. Concentrations in this International Standard refer to the type of measured values reported by the system.3.2blood-glucose meter component of a blood-glucose monitoring system that converts the product of a chemical reaction into the glucose concentration of the sample 3.3capillary blood-sample blood sample collected by skin puncture Note 1 to entry: A finger punctured by a lancet is commonly called a “fingerstick”.3.4commutability of a reference material property of a reference material, demonstrated by the closeness of agreement between the relation among the measurement results for a stated quantity in this material, obtained according to two given measurement procedures, and the relation obtained among the measurement results for other specified materials Note 1 to entry: The reference material in question is usually a calibrator and the other specified materials are usually routine samples.Note 2 to entry: The measurement procedures referred to in the definition are the one preceding and the one following the reference material (calibrator) in question in a calibration hierarchy. See ISO 17511 for further information.Note 3 to entry: The stability of commutable reference materials is monitored regularly.[ISO/IEC Guide 99:2007, definition 5.15]Note 4 to entry: Although blood would be the ideal matrix for reference materials for blood-glucose monitoring devices, such materials are not available at this time.2 © ISO 2013 – All rights reservedBritish Standards InstitutionProvided by IHS under license with BSI - Uncontrolled CopyLicensee=Chongqing Institute of quality and Standardization 5990390Not for Resale, 2015/8/27 08:52:05 No reproduction or networking permitted without license from IHSBS EN ISO 15197:2015 ISO 15197:2013(E)3.5consecutive selection method sampling method for a research study in which all subjects that meet the enrolment criteria are accepted in the order they volunteer for the study Note 1 to entry: This method will provide unbiased samples as long as no confounding variables are introduced during the trial period. For example, if a study lasts one morning, study subjects might not be representative of the target population, since subjects who visit the clinic in the morning might not be representative of all subjects who visit the clinic.Note 2 to entry: Adapted from Reference.[5]3.6disinfection process of destroying pathogenic organisms or rendering them inert Note 1 to entry: Adapted from Reference.[6]3.7influence quantity quantity that, in a direct measurement, does not affect the quantity that is actually measured, but affects the relation between the measurement indication and the measurement result EXAMPLE 1 Frequency in the direct measurement with an ammeter of the constant amplitude of an alternating current.EXAMPLE 2 Amount-of-substance concentration of bilirubin in a direct measurement of haemoglobin amount-of-substance concentration in human blood plasma.EXAMPLE 3 Temperature of a micrometer used for measuring the length of a rod, but not the temperature of the rod itself which can enter into the definition of the measurand.EXAMPLE 4 Background pressure in the ion source of a mass spectrometer during a measurement of amount-of-substance fraction.Note 1 to entry: An indirect measurement involves a combination of direct measurements, each of which may be affected by influence quantities.Note 2 to entry: Adapted from ISO/IEC Guide 99:2007, definition 2.52.3.8intermediate measurement precision intermediate precision measurement precision under a set of conditions of measurement that includes the same measurement procedure, same location and replicate measurements on the same or similar objects over an extended period of time, and can include other conditions involving changes Note 1 to entry: Interpretation of intermediate measurement precision requires that the changed and unchanged conditions be specified, particularly variables such as calibrations, reagent lots, measuring systems, operators and environmental conditions.Note 2 to entry: In evaluating IVD medical devices, the intermediate precision conditions are generally selected to represent the actual use conditions of the IVD medical device over an extended period of time.Note 3 to entry: Relevant statistical concepts are given in ISO 5725-3.Note 4 to entry: Intermediate precision can be expressed quantitatively in terms of the dispersion characteristics of the measured values, such as standard deviation, variance, and coefficient of variation.Note 5 to entry: Adapted from ISO/IEC Guide 99:2007, definitions 2.22 and 2.23.© ISO 2013 – All rights reserved 3British Standards InstitutionProvided by IHS under license with BSI - Uncontrolled CopyLicensee=Chongqing Institute of quality and Standardization 5990390Not for Resale, 2015/8/27 08:52:05 No reproduction or networking permitted without license from IHSBS EN ISO 15197:2015 ISO 15197:2013(E)3.9lay person individual without formal training in a relevant field or disciplineNote 1 to entry: For the purposes of this International Standard, a lay person is a user of a blood-glucose monitoring device who does not have specific medical, scientific or technical knowledge related to blood-glucose monitoring.Note 2 to entry: Adapted from ISO 18113-1, definition 3.34.3.10manufacturer’s selected measurement procedure measurement procedure that is calibrated by one or more primary or secondary calibrators and validated for its intended use Note 1 to entry: ISO 17511:2003, Figure 1 shows the manufacturer’s selected measurement procedure in thetraceability chain.Note 2 to entry: See ISO 17511:2003, 4.2.2 f).3.11manufacturer’s standing measurement procedure measurement procedure that is calibrated by one or more of the manufacturer’s working calibrators or higher types of calibrator and validated for its intended use Note 1 to entry: ISO 17511:2003, Figure 1 shows the manufacturer’s standing measurement procedure in the traceability chain.Note 2 to entry: See ISO 17511:2003, 4.2.2 h).3.12measurement accuracy accuracy closeness of agreement between a measured quantity value and a true quantity value of the measurand Note 1 to entry: The concept “measurement accuracy” is not a quantity and is not given a numerical quantity value. A measurement is said to be more accurate when it offers a smaller measurement error.Note 2 to entry: The term “measurement accuracy” is not used for measurement trueness and the term “measurement precision” is not used for measurement accuracy, which, however, is related to both these concepts.Note 3 to entry: “Measurement accuracy” is sometimes understood as closeness of agreement between measured quantity values that are being attributed to a measurand.[ISO/IEC Guide 99:2007, definition 2.13]3.13measurement bias bias estimate of a systematic measurement error Note 1 to entry: Bias is inversely related to trueness.Note 2 to entry: An estimation of bias is the average value of a series of measurements minus a reference quantity value.Note 3 to entry: Adapted from ISO/IEC Guide 99:2007, definition 2.18.4 © ISO 2013 – All rights reserved British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Chongqing Institute of quality and Standardization 5990390Not for Resale, 2015/8/27 08:52:05 No reproduction or networking permitted without license from IHS。
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血糖检测仪论文中英文资料英文原文SICE Annual Conference 2011September 13-18, 2011, Waseda University, Tokyo, JapanBlood Glucose Level Measurement by Confocal ReflectionPhotodetection SystemYuki Miyauchi，Takuro Horiguchi, Hiroaki Ishizawa, Shin-ichirou Tezuka and Hitoshi Hara Interdisciplinary Graduate School of Science and Technology, Shinshu University, Nagano, Japan(Tel : +81-268-21-5400; E-mail: f09a212@shinshu-u.ac.jp)Graduate School of Science and Technology, Shinshu University, Nagano, Japan (Tel : +81-268-21-5400; E-mail: 10fa221b@shinshu-u.ac.jp)Faculty of Textile Science and Technology, Shinshu University, Nagano, Japan (Tel : +81-268-21-5400; E-mail: zawa@shinshu-u.ac.jp)Yokogawa Electric Corporation, Nagano, Japan(Tel : +81-265-85-5620; E-mail: Shin-ichirou.Tezuka@) Yokogawa Electric Corporation, Nagano, Japan(Tel : +81-265-85-5620; E-mail: Hitoshi.Hara@)Abstract:In the present study, the confocal optical system has been constructed by using the near-infrared laser, and the reflection photodetection system of the living body has been developed. This system reduces the influence of a complex light scatter by the skin tissue and achieves a highly accurate measurement byconfocal optical system. And the initial experiment for the development of the non-invasive blood glucose meter that presumed the blood glucose level by thenear-infrared absorption of the living body has been done. In this report, the principle of the blood glucose level measurement of this system has been confirmed. The light intensity of the reflection in the living body skin tissue has been measured in the constructed system, and it has been compared with the blood glucose level reference value. As a result, the absorption of the reflected light that depended on the blood glucose level has been confirmed. The possibility of measuring the blood glucose level has been shown.Keywords: Confocal Optical System, Non-invasive, Blood Glucose, Near-infrared.1. INTRODUCTIONRecently, the diabetic increases remarkably [1, 2]. The self-monitoring of blood glucose (SMBG) is necessary and indispensable to treat the diabetic. However, present SMBG has been limited to the measurement that needs collecting blood. The patient has loads of pain, stress, and costs, etc. Therefore, the non-invasive blood glucose meter to be able to measure the blood glucose level is strongly expected [3-5]. In the present study, the confocal optical system has been constructed by using the near-infrared laser, and the reflection photodetection system of the living body has been developed. And the initial experiment for the development of the non-invasive blood glucose meter that presumed the blood glucose level by the near-infrared absorption of the living body has been done. This system reduces the influence of a complex light scatter by the skin tissue and achieves a highly accurate measurement by confocal optical system [6, 7]. In this report, the focus depth by the confocal optical system of this system has been confirmed. And the principle of the blood glucose level measurement of this system was confirmed. The light intensity of the reflection in the living body skin tissue has been measured in the constructed system, and it has been compared with the blood glucose level reference value. As a result, the absorption of the reflected light that depended on the blood glucose level has been confirmed. The possibility of measuring the blood glucose level has been shown.2. EXPERIMENTAL METHOD2.1 Measuring systemFig. 1 shows the optical system for the system constructed in the present study.A near-infrared ray VCSEL (Vertical Cavity Surface Emitting Laser) [8] of wavelength 1.55 μm was used for the light source of this system, and PD (InGaAsPIN photodiode, FGA21; THORLABS) was used for the photo detector. This system is a confocal optical system [9] that has the depth resolution and high plane resolution. Intensity of the reflected light from the sample surface side to the inside of sample can be detected by moving the window up and down. The source of light has stabilized by the APC (Auto Power Control) circuit [10].Fig. 2 Appearance of the polycarbonate plate measurementFig. 3 Appearance of a living body blood glucose level measurement2.2 Polycarbonate plate measurementThe polycarbonate plate was set up in the vicinity of the focus of object lens. The thickness of the polycarbonate plate is 5.0 mm and refractive indexes are n = 1.5. The focus of object lens from the sample surface side to the bottom side was scanned at intervals of 0.1 mm, and the reflected light of each point was acquired. The aluminum plate was set up in the polycarbonate plate bottom as a reflector. When measuring it, the state to remove the confocal pinhole to compare it with the image optics system was measured.2.3 Living body blood glucose level measurementThe present study was approved because of regulations of the Shinshu University ethics committee. And it won consent from the subject by the document. The relation between the amount of near-infrared absorption measurements of this system and the reference value that depended on the living body blood glucose level was examined.The measuring object was made a palmar side of the left hand thumb root. The depth of the measurement skin tissue was assumed to be 0.5 mm, 1.0 mm, 1.5 mm, and the surface. And the living body was made to stick to the window material of this system, and the reflection light intensity in each depth was measured. Moreover, the blood glucose level reference value was measured by the enzyme electrode method at the same time.A male in his twenties and an able-bodied person were made a subject. They were measured twice when they were hungry, and they were measured 9 times at intervals of 5 minutes after glucose load.1.EXPERIMENTAL RESULT1.1Reflection light intensity through the polycarbonate plateFig. 4 The focus depth of the confocal reflection photodetection systemFig. 4 showed the reflection light intensity in each point from the vicinity of the surface of the polycarbonate plate to the bottom. The peak of the scanning distance about 4.8 mm is a reflected light of the sample bottom. And it was confirmed by both of the image optics system and the confocal optical system. Moreover, the reflected light on the sample surface seen in the scanning distanceabout 1.4 mm was able to be confirmed only in the confocal optical system.3.2 Near-infrared absorption of a skin tissueThe logarithm value and the concentration of glucose of the skin tissue reflection light intensity are assumed to show a negative correlation from the Lambert-Beer law [11]. The reflection light intensity ratio on the inside and the surface of the skin tissue was used for the reflection light intensity. As a result, the fluctuation of the light intensity of the source of light is corrected. Fig. 5 showed the relation between the logarithm value and the blood glucose level reference value of the reflection light intensity ratio of each depth of 0.5 mm, 1.0 mm, and 1.5 mm. And the correlation coefficient and the standard error of each depth were shown in Table 1.Fig. 5 Near-infrared absorption of the skin tissue of each depth2.DISCUSSIO4.1 The focus depth of the confocal reflection photodetection systemThe reflection light intensity of the scanning in each point was overall large in the image optics system. Therefore, the reflection light peak on the sample surface was not able to be confirmed（Fig. 4）. It is shown that the reflection light intensity on the sample surface can be confirmed in the confocal optical system, and there is a depth resolution. Moreover, the distance between peaks of the reflected light of the sample surface and the bottom is about 3.4 mm. It is almost corresponding to optical distance t / n = 3.3 mm of t = 5.0 mm in thickness in refractive index n = 1.5. It was shown to be able to select the measurement depth according to the refractive index. The full width at half maximum of the peak of the reflected light in the confocal optical system is about 1mm. It can be said that the focus depth of the confocal reflection photodetection system is about 1.0 mm.Fig. 6 EGA result in relation between the reference values and the predictive values4.2 Near-infrared absorption of a skin tissueThe attenuation of the logarithm value of the reflection light intensity ratio that depended on the blood glucose level was confirmed in 0.5 mm and 1.5 mm in the depth of the measurement skin tissue. The possibility of presuming the blood glucose level from the reflection light intensity ratio logarithm value was shown from the logarithm value of the reflection light intensity ratio and the correlation of the bloodglucose level. However, the attenuation of the logarithm value of the reflection light intensity ratio thatdepended on the blood glucose level was not able to be confirmed by the depth of 1.0 mm. It is thought that this is because a steady measurement was not able to be done because the scattered structure of the skin tissue is organizing and it is not uniform. It will be necessary to examine the best measurement depth in detail in the future. The single regression analysis was done to the data of 1.5mm that the relation of the attenuation of the blood glucose reference value and the reflection light intensity was good in depth. Fig.6 showed the relation of the predictive value forecast by the reference value and the single regression analysis. And we used Error Grid Analysis (EGA). The EGA is developed a system for the evaluation of the clinical implications of patient generated blood glucose value, which takes into account the factors. A and B zone are clinical safety. C zone is a little danger. D and E zone are danger [12]. As a result of the single regression analysis, it was in the correlation with high blood glucose reference value and blood glucose forecast value. Moreover, all data was included in A and B zone in the result of EGA. The plot was distributed clinical within the effective range. Therefore, it was shown that the validity of the blood glucose level measurement by this system. And it is necessary to increase the number of measurements and to confirm the stability of the measurement.5. CONCLUSIONThe confocal optical system has been constructed by using the near-infrared laser, and the reflection photodetection system of the living body has been developed. The depth resolution of the system has been confirmed by measuring the polycarbonate plate. And it has been shown to be able to select the depth when the living body was measured. The possibility of presuming the blood glucose level from the reflection lightintensity ratio logarithm value has been shown from the logarithm value of the reflection light intensity ratio and the correlation of the blood glucose level. And EGA plot has been built by these data. The measurement of this system has been shown an effective possibility clinical. Therefore, the possibility of measuring the blood glucose level has been shown. However, the attenuation of the logarithm value of the reflection light intensity ratio that depended on the blood glucose level according to depth has been not able to be confirmed. This is because a steady measurement was not able to be done because the scattered structure of the skin tissue is organizing and it is not uniform. It will be necessary to examine the best measurement depth in detail in the future. And it is necessary to increase the number of measurements and to confirm the stability of the measurement. It is necessary to increase the number of subjects and to confirm the interindividual variation.REFERENCES[1] WHO 2010 Web Site, “http://www.who.int/diabetes/en/” [Accessed July 18, 2010].[2] 2009 International Diabetes Web Site, “http:/content/foreword/”. [Accessed July 18, 2010].[3] M. R. Robinson, R. P. Eaton, D. M. Haaland, G. W. Koepp, E. V. Thomas, B. R. Stallard, and P. L. Robinson, “Noninvasive Glucose Monitoring in Diabetic Patients: A Preliminary Evaluation”, CLIN. CHEM,38-9, pp.1618-1622,1992.[4] S. Koyama, Y. Miyauchi, H. Ishizawa, “Clinical Application of Non-invasive Blood Glucose Monitoring System”, J. Illum. Engng. Inst. Jpn., vol.95, no.5, 2011.[5] S. Koyama, Y. Miyauchi, T. Horiguchi, H. 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