AMR.287-290.2725
CODEX STAN 295R-2009 Regional Standard for Ginseng Products(人参制品区域标准)英文版

REGIONAL STANDARD FOR GINSENG PRODUCTS(Asia1)CODEX STAN 295R-20091. SCOPE1.1This standard applies to the ginseng products as defined in Section 2 below and offered for directconsumption, including for catering purposes or for repacking if required. It does not apply to the product when indicated as being intended for further processing. This standard applies to ginseng products2used as a food or food ingredient and does not apply to products used for medicinal purposes.1.2 This Standard applies only in those jurisdictions where products defined in2.1 are regulated as foods.2. DESCRIPTION2.1 P RODUCT D EFINITIONThe compulsory ingredient of ginseng product is fresh ginseng roots suitable to eating, derived from Panax ginseng C.A. Meyer and P. quinquefolius L., cultivated for commercial purposes and used for foods. Ginseng products should be packaged in such a manner as to safeguard the hygienic, nutritional, technological and organoleptic quality of the products.2.2 T YPES OF G INSENG P RODUCTS2.2.1 Dried Ginseng2.2.1.1 Dried Raw GinsengDried Raw Ginseng is manufactured when fresh ginseng roots are sun dried or hot air dried or dried using other recognized methods. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced.2.2.1.2 Dried Steamed GinsengDried Steamed Ginseng is manufactured when fresh ginseng roots are prepared using the steaming method or other recognized methods, and dried. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced.2.2.2 Ginseng Extract2.2.2.1 Raw Ginseng ExtractRaw Ginseng Extract is manufactured when soluble components of fresh ginseng roots or Dried Raw Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. This product has a dark brown colour and a high viscosity when much of the water is removed from it. The product may be also presented as a powdered type through spray- or freeze-drying.2.2.2.2 Steamed Ginseng ExtractSteamed Ginseng Extract is manufactured when soluble components of Dried Steamed Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. This product has a dark brown colour and a high viscosity when much of the water is removed from it. The product may be also presented as a powdered type through spray- or freeze-drying.3. ESSENTIAL COMPOSITION AND QUALITY FACTORS3.1 I NGREDIENTSFresh ginseng roots as defined in Section 2.1.1Members of the Codex Alimentarius Commission in the Region of Asia are indicated on the Codex website at /web/members_area.jsp?lang=EN.2Any health claims should comply with the Codex Guideleines for Use of Nutrition and Health Claims (CAC/GL 23-1997)3.2 Q UALITY F ACTORSGinseng products shall have normal flavour, colour, taste and a ginsenoside pattern3unique to ginseng as well as be free from foreign matters.3.2.1 Dried Ginseng(a)Moisture: no more than 14.0% (Powdered type: no more than 9.0%)(b)Ash: no more than 6.0%(c)Water-saturated 1-butanol extracts: no less than 20 mg/g(d)Ginsenoside Rb1: to be identifiedIn addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified.3.2.2 Ginseng Extracts3.2.2.1 Ginseng Extracts (liquid form)(a)Solids: no less than 60.0%(b)Water-insoluble solids: no more than 3.0%(c)Water-saturated 1-butanol extracts: no less than 70 mg/g(d)Ginsenoside Rb1: to be identifiedIn addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified.3.2.2.2 Ginseng Extracts (powdered form)(a)Moisture: no more than 8.0%(b)Water-insoluble solids: no more than 3.0%(c)Water-saturated 1-butanol extracts: no less than 70 mg/g(d)Ginsenoside Rb1: to be identifiedIn addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified.3.3 D EFINITION OF D EFECTSThe following defects shall be applied to the dried ginseng.(a)Insect-damaged ginseng: Ginseng that is visibly damaged by insects or contains dead insects(b)Mouldy ginseng: Ginseng that is visibly affected by mould3.4 C LASSIFICATION OF "D EFECTIVES"A container that fails to meet one or more of the applicable quality requirements, set out in Sections 3.2 and3.3, shall be considered a "defective".3.5 L OT A CCEPTANCEA lot can be considered as meeting the applicable quality requirements referred to in Sections 3.2 and 3.3, when the number of "defectives", defined in Section 3.4, does not exceed the acceptance number (c) of the appropriate sampling plan.3The unique constituents of ginseng are found to be a complex mixture of saponins often referred to as ginsenosides, and more than 30 ginsenosides are known. Ginsenoside Rb1 or ginsenoside Rf is one of the major ginsenosides. Ginsenoside Rb1 is identified in all ginseng species in quantities, while ginsenoside Rf is identified mainly in Panax ginseng C.A. Meyer.4. CONTAMINANTSThe products covered by this Standard shall comply with the maximum levels of the Codex General Standard for Contaminants and Toxins in Foods (CODEX/STAN 193-1995).The products covered by this Standard shall comply with the maximum residue limits for pesticides established by the Codex Alimentarius Commission.5. HYGIENE5.1 It is recommended that the products covered by the provisions of this Standard be prepared andhandled in accordance with the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969), and other relevant Codex texts, such as Codes of Hygienic Practice and Codes of Practice.5.2 The products should comply with any microbiological criteria established in accordance with thePrinciples for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997).6. LABELLINGThe products covered by this Standard shall be labelled in accordance with the Codex General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985). In addition, the following specific provisions apply:6.1 N AME OF THE P RODUCTThe name of the products defined in subsections 2.2.1.1, 2.2.1.2, 2.2.2.1 and 2.2.2.2 shall be “Dried Raw Ginseng”, “Dried Steamed Ginseng”, “Raw Ginseng Extract”, and “Steamed Ginseng Extract”, respectively. In this case, the products manufactured with P. ginseng C.A. Meyer can be named “White Ginseng”, “Red Ginseng”, “W hite Ginseng Extract”, and “Red Ginseng Extract”.6.2 N AME OF THE G INSENG S PECIESAll ginseng products shall be labelled the scientific or common name of the ginseng that is used as raw material. The common names of the ginseng shall be declared in accordance with the law and custom of the country where the product is consumed, in a manner not to mislead the consumer.6.3 C OUNTRY OF ORIGINThe country of origin of the product and/or raw material shall be declared if its omission is likely to mislead or deceive the consumer.6.4 L ABELLING OF N ON-R ETAIL C ONTAINERSInformation about non-retail containers shall be given on the container or in accompanying documents, except that the name of the product, lot identification and the name and address of the manufacturer, packer or distributor, as well as storage instructions, shall appear on the container. However, lot identification, and the name and address of the manufacturer, packer or distributor may be replaced by an identification mark, provided that such a mark is clearly shown in the accompanying documents.6.5 O THER L ABELLING R EQUIREMENTSExcept when otherwise specified by national legislation, the products should have a clear marking to indicate that they are not intended for medicinal purposes, including other labelling(s) stipulated by any country where ginseng products are distributed.7. METHODS OF ANALYSIS AND SAMPLING7.1 D ETERMINATION OF M OISTUREAccording to AOAC 925.45.7.2 D ETERMINATION OF S OLIDAccording to AOAC 925.45 and calculated by subtracting the content of water from 100%.7.3 D ETERMINATION OF A SHAccording to AOAC 923.03.7.4 D ETERMINATION OF W ATER-INSOLUBLE S OLIDSAccording to the method described in Annex A.7.5 D ETERMINATION OF W ATER-SATURATED 1-BUTANOL EXTRACTS According to the method described in Annex B.7.6 I DENTIFICATION OF G INSENOSIDES Rb1 AND RfAccording to the method described in Annex C.Determination of Water-insoluble Solid ContentPlace ca 1 g sample in 25 ml centrifugal tube with constant weight. Add 15 ml of distilled water and dissolve the sample. Centrifuge for 15 min at 3000 rpm and discard supernatant. Repeat twice this centrifugation. Dry centrifugal tube and residue to constant weight at 105°C. Report results in percent.water-insoluble solid content (%) = (W1-W0)/ S × 100S: weight of sample (g)W1: weight of centrifugal tube and residue after drying (g)W0: weight of centrifugal tube (g)* The method mentioned in Annex A is stipulated in the Korean Food Standards Law and modifies the “AOAC Official Method 950.66.”Determination of water-saturated 1-butanol extracts1. Preparation of water-saturated 1-butanolMix 1-butanol with water in separatory funnel in the ratio of 70:30 and shake it vigorously. Let stand until the upper and lower phases are separated. Discard lower layer (water layer).2. Analysismethod2.1 Dried ginsengWeigh ca 5 g test portion, ground to pass 80 mesh or finer sieve, into 250 ml erlenmeyer flask and reflux with 50 ml water saturated 1-butanol on a water bath at 80°C for 1 hour. Decant 1-butanol into another 250ml erlenmeyer flask. Repeat twice the above extraction. Combine the solvent and filter into a 250 ml separatory funnel. Add 50 ml of distilled water. Shake and stand until the upper and lower layer are separated completely into two layers. Collect 1-butanol layer (upper layer) in an evaporation flask, vacuum-evaporate to dryness. Add 50 ml of diethyl ether, re-flux it on a water bath approximately at 46°C for 30 minutes, and decant the diethyl ether. Dry flask and contents to constant weight at 105°C. Report increase in weight flask as "1-butanol extracts in ginseng". Express the result as mg per gram on dried ginseng.water-saturated 1-butanol extracts (mg/g) = (A-B) / SS: weight of sample (g)A: weight of flask after concentrating and drying extracts (mg)B: weight of flask (mg)2.2 Ginseng extract (including a powered type)Place 1~2 g sample in 250 ml erlenmeyer flask, dissolve in 60ml water and transfer into separating funnel. Add 60ml of diethyl ether. Shake and stand until the upper and lower layer are separated. Collect lower layer and extract with 60 ml water saturated 1-butanol for three times. Combine the solvent into a 250 ml separatory funnel. Add 50 ml of distilled water. Shake and stand until the upper and lower layers are separated completely into two layers. Collect 1-butanol layer (upper layer) in an evaporation flask with constant weight, vacuum-evaporate to dryness. Dry flask and contents to constant weight at 105°C. Report increase in weight flask as "1-butanol extracts in ginseng extract". Express the result as mg per gram on ginseng extract.References1. Planta Medica, Vol. 25, pp 194-202, 19742. Chem. Pharm Bull., Vol. 14, pp 595-600, 19663. Korean J. Ginseng Sci., Vol. 10(2), pp 193-199, 1986Identification of ginsenosides Rb1 and RfGinsenosides in ginseng products can be identified either by thin layer chromatography (TLC) or high performance liquid chromatography (HPLC).1. Preparation of sample solutionDilute the dried 1-butanol extract of Annex B with ten-fold volume of methanol, dissolve completely, and filter through 0.45 µm membrane filter.2. Preparation of standard solutionDissolve standard ginsenosides, such as ginsenoside-Rb1 and -Rf, in methanol to make a 1% solution and filter through 0.45 µm membrane filter.3. Identification3.1 Thin layer chromatographySpot 2-5 µl of the standard and sample solutions, as indicated in the above, on TLC plate (silica gel), previously dried at 110°C for 15 minutes in dry oven. Develop with an upper solution of 1-butanol:ethylacetate:water (5:1:4, v/v/v) or a lower solution of chloroform:methanol:water (65:35:10, v/v/v). Spray 10% sulfuric acid or 30% sulfuric acid-ethanol solution over TLC plate and oven dry it at 110°C for 5-10 minutes to reveal its colour. Identify the ginsenosides of Ginseng products by comparing the Rf values and colours with those of standard ginsenosides.3.2 High performance liquid chromatographyPrepare standard and sample solutions, as indicated in the above. Analyze ginsenoside with HPLC depending upon the operating condition. Identify ginsenosides of sample by comparing retention times of peaks with those of the standard.<Operating condition>Column: NH2 column, µ-Bondapak C18 column, carbohydrate analyzing column or equivalent Detector: UV (203 nm) or ELSDEluent:UV: acetonitrile: water (30:70, v/v)ELSD: acetonitrile: water: isopropanol (94.9:5.0:0.1, v/v/v)Flow rate: 1.0 ml/min ~ 2.0 ml/minReferences1. Journal of Chromatography, Vol. 921, Issue 2, 2001, pp 335-3392. Journal of Chromatography, Vol. 868, Issue 2, 2000, pp 269-2763. Journal of Chromatography, Vol. 356, 1986, pp 212-2194. Journal of Chromatography, Vol. 499, 1990, pp 453-4625. Planta Medica, Vol. 212, Issue 1, 1981, pp 37-496. J. Pharm. Soc. Korea, 23(3,4), 1979, pp181-186。
助听器注册技术审查指导原则

助听器注册技术审查指导原则文档编制序号:[KK8UY-LL9IO69-TTO6M3-MTOL89-FTT688]附件12助听器注册技术审查指导原则(2016年修订版)本指导原则旨在指导注册申请人对助听器注册申报资料的准备及撰写,同时也为技术审评部门审评注册申报资料提供参考。
本指导原则是对助听器的一般要求,申请人应依据产品的具体特性确定其中内容是否适用,若不适用,需具体阐述理由及相应的科学依据,并依据产品的具体特性对注册申报资料的内容进行充实和细化。
本指导原则是供申请人和审查人员使用的指导文件,不涉及注册审批等行政事项,亦不作为法规强制执行,如有能够满足法规要求的其他方法,也可以采用,但应提供详细的研究资料和验证资料。
应在遵循相关法规的前提下使用本指导原则。
本指导原则是在现行法规、标准体系及当前认知水平下制定的,随着法规、标准体系的不断完善和科学技术的不断发展,本指导原则相关内容也将适时进行调整。
一、适用范围本指导原则适用于《医疗器械分类目录》中第二类助听器,管理类代号为6846。
第三类植入式助听器或其他应用有创法的助听器不适用本指导原则。
二、技术审查要点(一)产品名称要求助听器的命名应采用《医疗器械分类目录》或国家标准、行业标准中的通用名称;也可按“佩戴方式+信号处理方式”的方法命名,例如:耳背式数字助听器;采用骨传导原理的助听器,名称中应体现骨导式。
(二)产品的结构和组成助听器基本结构包括输入换能器(如传声器、受话器等)、信号调理单元(如放大器、数字处理器等)、输出换能器(如耳机、骨振器等)、电源(一般为纽扣电池或干电池)。
零配件可由耳模(耳塞)、导线、导声管等组成。
1.按传导方式,助听器可分为气导式助听器、骨导式助听器,目前大部分助听器都是气导式助听器。
气导式助听器:通过气导方式放大后的声音通过耳道气体传导到内耳。
骨导式助听器:将放大后的声音通过乳突或头骨机械振动的方式传导到内耳。
2.按信号处理方式,助听器可分为模拟助听器、数字助听器,数字助听器可有多个通道、多个频段。
鸿怀VM821Q1 AMR 4-Pin 方向编码器 IC 说明书

FEATURES• Integrated quadrature sensor IC • Pole size independent operation• 4-pin quadrature, open collector outputs• -40°C to 150°C operating temperature range • Zero speed operation • No calibration required• Insensitive to mechanical vibration• Protection against reverse polarity and short circuit POTENTIAL APPLICATIONS• Industrial speed and direction and position feedback • Encoders• Conveyer rollers speed, process line speed and direction • Gearbox output speed• Positioning roller speed and direction • Garage door opening systems • Induction motors • Fan speed systems• Electric actuated blind position • Pumps and compressors• Integrated seals and bearingsPORTFOLIOThe Honeywell VM821Q1 AMR 4-Pin Quadrature Sensor IC joins the following related products:• VM721D1 AMR 2-Pin PWM Speed and Direction Sensor IC •VM721V1 AMR 2-Pin Speed Sensor ICDESCRIPTIONHoneywell’s Anisotropic Magnetoresistive (AMR) 4-Pin Quadrature Sensor Integrated Circuit (IC) is designed todetect the speed and direction and position of a ring magnet encoder target using a unique* bridge design. The frequency of the output is proportional to the rotational speed of the target, and the rotational direction is encoded by the phase between the outputs. The sensor IC works over a wide range of speeds, temperatures and air gaps.VALUE TO CUSTOMERSThe VM821Q1 sensor IC has a higher sensitivity AMR bridge array that operates with a larger airgap than Hall-effect sensor ICs, which allows for enhanced design flexibility and assembly tolerances. The sensor IC has been optimized to provide an output that is not affected by target runout or sudden air gap changes. It is insensitive to magnet pole size, allowing one sensor to be paired with different ring magnet applications.DIFFERENTIATIONHoneywell’s unique solution utilizes the AMR bridge in saturation, which provides a more stable output response when the system has vibration, sudden air gap changes, or target runout without requiring complex magnitude compensation algorithms. The AMR signal has greatersensitivity than Hall-effect sensor ICs, and does not require automatic gain control or chopper stabilization that can lead to increased jitter over the operating range. *Patent PendingAMR 4-Pin Quadrature Sensor Integrated CircuitVM821Q132336294Issue E23Advanced Sensing TechnlologiesAdvanced Sensing Technologies AMR 4-Pin Quadrature Sensor ICVM821Q1AMR 4-Pin Quadrature Sensor ICVM821Q1Figure 1. Block DiagramNOTICEAbsolute maximum ratings are the extreme limits the device will momentarily withstand without damage to the device. Electrical and mechanical characteristics are not guaranteed if the rated voltage and/or currents are exceeded, nor will the device necessarily operate at absolute maximum ratings.Phase Calculation DefinitionThis method isolates phase from duty cycle. It also best correlates to analysis of the fundamental frequency in the frequency domain.Where:A rising = rising edge of output A A falling = falling edge of output AB rising = nearest falling edge of output B to A rising B falling = next falling edge of output BT = period of one cycleB rising + B falling2Phase (°) =A rising + A falling2-*((360TNOTICELarge, stray magnetic fields in the vicinity of the sensor may adversely affect sensor performance.For more informationHoneywell Advanced SensingTechnologies services its customers through a worldwide network of sales offices and distributors. For application assistance, current specifications, pricing or the nearest AuthorizedDistributor, visit /ast or call:Asia Pacific +65 6355-2828Europe +44 (0) 1698 481481USA/Canada +1-800-537-6945Honeywell Advanced Sensing Technlogies830 East Arapaho Road Richardson, TX /ast4Advanced Sensing TechnlologiesAMR 4-Pin Quadrature Sensor ICVM821Q1Figure 5. Dimensions and Product Marking (For reference only mm/[in])0,80Date code (one digit: 1-9)ADDITIONAL INFORMATIONThe following associated literature is available on the Honeywell web site at :• Installation instructions• Application notes • Technical notes • CAD Models• Evaluation samples available from your local Honeywell contact32336294-E-EN | E | 05/21© 2021 Honeywell International Inc.Product MarkingFigure 4. Sensor IC Mounting OrientationRadialAxialWarranty/RemedyHoneywell warrants goods of its manufacture as being free of defective materials and faulty workmanship during theapplicable warranty period. Honeywell’s standard product warranty applies unless agreed to otherwise by Honeywell in writing; please refer to your order acknowledgment or consult your local sales office for specific warranty details. If warranted goods are returned to Honeywell during the period of coverage, Honeywell will repair or replace, at itsoption, without charge those items that Honeywell, in its sole discretion, finds defective. The foregoing is buyer’s sole remedy and is in lieu of all other warranties, expressed or implied, including those of merchantability and fitness for a particular purpose. In no event shall Honeywell be liable for consequential, special, or indirect damages.While Honeywell may provide application assistancepersonally, through our literature and the Honeywell web site, it is buyer’s sole responsibility to determine the suitability of the product in the application.Specifications may change without notice. The information we supply is believed to be accurate and reliable as of this writing. However, Honeywell assumes no responsibility for its use.。
认可的医疗器械受检目录助听器

全项目
YY0306-1998热辐射类治疗设备安全专用要求
7
多参数监护仪
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YZB/鲁0271-2003多参数监护仪
取消除颤效应的防护限制项
8
医用内窥镜及附件
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GB11244-2005医用内窥镜及附件通用要求GB9706.19-2000医用电气设备第2部分内窥镜设备安全专用要求
9
医疗器械生物学评价
认可的医疗器械受检目录助听器
序号
产品名称
项目/参数
检测标准(方法)名称及编号(含年号)
说明
序号
名称
1
助听器
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GB 6657-1986助听器电声特性的测量方法
GB 6658-1986具有感应拾音线圈输入的助听器电声特性的测量方法
GB 6659-1986具有自动增益控制电路的助听器电声特性的测量方法
GB 6660-1986助听器及其有关设备的符号与标记
GB 6661-1986插入式耳机的乳头状接头
SJ/T10862-1996助听器交货时质量检验的性能测量
GB/T14199-1993盒式助听器总技术条件
2
高频手术设备及附件
部分项目
GB9706.4-1999医用电气设备第二部分高频手术设备安全专用要求
骨植入
GB/T 16886.6-1997医疗器械生物学评价第6部分:植入后局部反应试验
10
外科植入物用不锈钢
1
δ铁素体
GB 4234-2003外科植入物用不锈钢
2
非金属夹杂物
3
晶粒度
11
测量、控制和试验室用电气设备
部分项目
核酸片段分析仪比较

核酸片段分析仪比较
机型 价钱(USD) 加样方式 制胶 通道数 检测样品数 高通量 单一样品花费 分析时间 体积(cm) 重量(kg) 分离原理 分离片段范围广 高灵敏度 高分辨率 数据显示 节省样本 安全 Qsep100 25000-30000 自动加样,96孔板连续检测 无需制胶,即开即用笔式凝胶卡夹 单通道卡夹 Qiagen Qiaxcel 45000-55000 自动加样,96孔板连续检测 无需制胶,即开即用凝胶卡夹 8或12通道凝胶卡夹可选 Bio-Rad Experion 25000-35000 手动加样 芯片制胶 单通道 每次检测12个样品 每轮可分析12个样品 20 RMB Agilent 2100 25000-35000 手动加样 芯片制胶 单通道 每次检测12个样品 每轮可分析12个样品 20 RMB 3-10 min/ 12个样品 29*16*41 10 biochip 25 bp -12 kbp 0.1 ng/µl 5-20 电泳图谱和峰图 0.1 µL 无敞开式EB污染
灵活测试,可以单一测试样品,不用 同时检测8或12个样品,每次上样8 担心浪费现象 或12的倍数 每轮可分析96个样品 <5 RMB 2-7 min/样品 38*40*30 15 CGE 15 bp-15 kbp 0.1 ng/µl 2-4(300bp以下) 电泳图谱和峰图 0.1 µL 无敞开式EB污染 每轮可分析9.5-1.3 h/96 30 min/10-12个样品 个样品 36*56*35 23 CGE 15 bp-10 kbp 0.1 ng/µl 3-5 电泳图谱和峰图 0.1 µL 无敞开式EB污染 15*31*29 4.58 biochip 25 bp -12 kbp 0.1 ng/µl 5-20 电泳图谱和峰图 0.1 µL 无敞开式EB污染
世界卫生组织儿童标准处方集

WHO Model Formulary for ChildrenBased on the Second Model List of Essential Medicines for Children 2009世界卫生组织儿童标准处方集基于2009年儿童基本用药的第二个标准目录WHO Library Cataloguing-in-Publication Data:WHO model formulary for children 2010.Based on the second model list of essential medicines for children 2009.1.Essential drugs.2.Formularies.3.Pharmaceutical preparations.4.Child.5.Drug utilization. I.World Health Organization.ISBN 978 92 4 159932 0 (NLM classification: QV 55)世界卫生组织实验室出版数据目录:世界卫生组织儿童标准处方集基于2009年儿童基本用药的第二个标准处方集1.基本药物 2.处方一览表 3.药品制备 4儿童 5.药物ISBN 978 92 4 159932 0 (美国国立医学图书馆分类:QV55)World Health Organization 2010All rights reserved. Publications of the World Health Organization can be obtained fromWHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: ******************). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the aboveaddress(fax:+41227914806;e-mail:*******************).世界卫生组织2010版权所有。
厦门市商务局关于美国企业对涉华特定高密度光纤设备及其组件提起337调查申请的通告

厦门市商务局关于美国企业对涉华特定高密度光纤设备及其组件提起337调查申请的通告文章属性•【制定机关】厦门市商务局•【公布日期】2020.03.03•【字号】•【施行日期】2020.03.03•【效力等级】地方规范性文件•【时效性】现行有效•【主题分类】商务综合规定正文厦门市商务局关于美国企业对涉华特定高密度光纤设备及其组件提起337调查申请的通告2020年2月24日,美国Corning Optical Communications LLC根据《美国1930年关税法》第337节规定向美国际贸易委员会提出申请,主张对美出口、在美进口及销售的特定高密度光纤设备及其组件(High-Density Fiber Optic Equipment and ComponentsThereof)侵犯了其专利权。
美国AFL Telecommunication Holdings LLC, d/b/a AFL,Duncan, SC、美国 Inc., New Castle, DE、瑞士Huber+Suhner AG, Switzerland、美国Huber+Suhner, Inc., Charlotte, NC、美国Legrand North America, LLC, West Hartford, CT、美国Leviton Manufacturing Co., Inc., Melville, NY、美国Panduit Corporation, Tinley, IL、中国上海Shanghai TARLUZ Telecom Tech. Co., Ltd., d/b/aTARLUZ, China上海态路通信技术有限公司、中国广东Shenzhen Anfkom Telecom Co., Ltd., d/b/a AnfkomTelecom, China、加拿大The LAN Wirewerks Research Laboratories Inc., d/b/aWirewerks, Can ada、美国The Siemon Company, Watertown, CT、美国Total Cable Solutions, Inc., Springboro, OH、中国广东Wulei Technology Co., Ltd., d/b/a Bonelinks, China为列名被告。
Ambion公司 mMESSAGE mMACHINE

USER GUIDE
mMESSAGE mMACHINE® Kit
Publication Part Number 1340M Rev. F Revision Date November 2011
For Research Use Only. Not intended for any animal or human therapeutic or diagnostic use.
Contents
About This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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Effect of Far-infrared Pre-heat Treatment and adding Methylenediphenylisocyanate(MDI) on Adhesion Bonding between Reinforcement and Rubber of Conveyer BeltWen Hao Hsing1,a, Yuan Jyun Huang2,b, Yi Kui Wang3,c, and Ming Zheng Lin4,d 1Department of Textile Engineering, Chinese Culture University, No.55, Hwa-Kang Road,Taipei City , Taiwan 11114,Chinese Taipei2Industrial Technology R & D Master Program on Textile Engineering, Chinese Culture University, No.55, Hwa-Kang Road,Yang-Ming-Shan, Taipei City , Taiwan 11114,Chinese Taipei3Graduate Institute of Nanomaterials, Chinese Culture University, No.55, Hwa-Kang RoadTaipei City, Taiwan 11114, Chinese Taipei4San Wu Textile Co., Ltd, No. 106, Sec. 2, Chang Mei Rd. Homei, Changhwa, Taiwana hsing@.tw, a d6172000@, c junV878@, d cwf@Keywords: Far-infrared, fabrics surface humidity, fabrics surface temperature, adhesion strength Abstract.This research of the PET/Nylon fabric pre-treatment by far-infrared and adding Methylenediphenylisocyanate(MDI) to 0%,2%,4%,6% and 8%. According to fabric absorption medicament effect and bonding strength content analyzing. Heating 20 seconds, after stop 10 seconds and then heat 20 seconds and add 8% Methylenediphenylisocyanate(MDI) is the beast treatment, fabric-fabric adhesion strength is 16.73 kgf, fabric-rubber adhesion strength is 18.70 kgf, fabric-fabric and fabric-rubber adhesion strength that improve 54.6%,69.6%.IntroductionThe PET/Nylon conveyer belt is an artificial rubber product which is widely used in industry. At the early stage, the conveyer belt used cotton yarn fabric as reinforcements [1]. The chemical method includes adding Denabond and decrement treatment. And the physical theory includes pre-heating and cooling,electrostatic treatment,Electron Beam irradiation, Microwave irradiation, Plasma radiation and Pre-heating Treated by Far-Infrared .The research is to discover more about Pre-Heating and Cooling Process and Pre-heating Treated by Far-Infrared process [3-4].Table.1 is the adhesion of polyester/Nylon fabric properties review.Table.1 The adhesion of difference method review [2-4].ExperimentIn materials, the PET/Nylon fabric (T 1000D/4 x N66 840D/4) where is used for conveyor belt and RFL solution and Methylenediphenylisocyanate(MDI) were supplied by San Wu Textile Co. Ltd.In this experiment, pre-heat the far infrared heater for 3~5minutes, the temperature of the heater will need to be raised to 200˚C.First, heat up Conveyer belt fabric in the far infrared heater for 20 seconds and reheat the fabric 20 seconds and measure the fabric surface humidity and temperature continuously.( The fabric surface humidity measuring: Put the electric hygrometer on the fabric, and measure humidity changes nearby the fabric surface). Morphological changes as a result of far-infrared treatment were observed by scanning electron microscopy (SEM). The tensile broken strength test was performed according to CNS 12915. To measure the adhesion strength of the rubber coated fabrics, an adhesive peel test was performed according to CNS 15139. Results and DiscussionFigure.1 (a-b) showed that the appearances of untreated, PET and Nylon fibers seen to be smooth. Figure.1 (c) showed that the treated PET fiber heated 20 seconds twice at interval of 10 seconds and by far-infrared heater. Figure.1 (d) showed that the treated Nylon fiber heated twice 20 second at interval of 10 seconds and by far-infrared heater. When untreated with heater, the fibers had shrink and destroyed slightly, which had made the fibers forming roughly and superficially.a b c dFigure.1 (a) Scanning electron micrographs of untreated PET fiber (b) Scanning electron micrographs of untreated Nylon fiber(c) Scanning electron micrographs of PET fiber heated twice 20 second at interval of 10 second by far-infrared heater(d) Scanning electron micrographs of Nylon fiber heated 20 seconds twice at interval of 10 seconds by far-infrared heater.Figure.2 were the test results for the conveyer belt fabric heated for 20 second, By putting the fabric into the heater, the fabric humidity increased because the moisture in the fiber has been vaporized. Furthermore, when the moisture turned into small particles, the humidity started decreasing. When the fabric left the heater, the humidity was not increased at the moment, the reason was that the moisture near by the fabric was absorbed by fibers and the humidity was in dry condition. Therefore, the moisture on the fabric was able to evaporate more if the heating time increased and closer the heat.By putting the fabric into the heater, the surface temperature increased rapidly, and the temperature decreased when the fabric has been taken out from the heater. The fabric must be soaked in the solvents with the temperature below 40℃ to ensure the quality of the solvents on the fabric, and that the two-stage 20 seconds of processing, the temperature increased to 84.1 ℃, cooling to below 40 ℃ to be 62 seconds, the cloth cover humidity from about 49% to 30%.2726Applications of Engineering MaterialsFigere.2 The temperature,humidity,moisture of the PET/Nylon fabric pre-heat 20s and two-stage20s by far infrared heaterTable.2 Show that the PET/Nylon fabric warp break strength after far-infrared treatment. The fiber break strength had dropped due to the heating process of the far-infrared treatment, the break strength had decreased slightly.Table.2 The PET/Nylon fabric warp break strength after far-infrared treatment.Treatment condition Treatment time(sec) Break strength(Kgf/cm) Decrease percent(%)Untreated - 298.15 - Pre-heat once 20 270.63 9.2 Pre-heat to two-stage20257.2213.72Table.3 Show that the PET/Nylon fabric pre-treatment by far-infrared and adding Methylenediphenylisocyanate(MDI) to 0%, 2%, 4%, 6% and 8% adhesion strength between fabric and fabric, Table.4 Show that the PET/Nylon fabric pre-treatment by far-infrared and adding Methylenediphenylisocyanate(MDI) to 0%, 2%, 4%, 6% and 8% adhesion strength between fabric and rubber, From the table 3 and table 4, the condition of the fabric and rubber adhesion strength were always better than others with twice of treatments. The reason was because the surface of the fiber became rough after heating and the spaces between each fiber were bigger, therefore, it was easier to fill the rubber into the spaces and make the adhesion strength stronger.Table.3 Adhesion strength between fabric and fabric of PET/NylonTreatment conditionAdhesion strength between fabric and fabric (Kgf)Methylenediphenylisocyanate(MDI)0%2% 4% 6% 8% pre-heat 20s 10.06 11.21 12.49 14.16 15.16 Increase (%) 0 11.43 24.15 40.7 50.7 pre-heat 20s twice 10.82 12.04 13.10 14.88 16.73 Increase (%)11.2721.1137.554.6Table.4 Adhesion strength between fabric and rubber of PET/Nylon Treatment conditionAdhesion strength between fabric and rubber (Kgf) Methylenediphenylisocyanate(MDI)0% 2% 4% 6% 8% pre-heat 20s 10.60 11.92 13.31 15.01 17.04 Increase (%) 0 12.4 25.5 41.6 60.7 pre-heat 20s twice 11.02 12.48 15.81 16.32 18.70 Increase (%)13.243.448.169.6ConclusionsAfter the experiments, we had come out some conclusions as below. First, PET and Nylon fibers seen to be smooth when untreated with heater, but after heating by far-infrared heater, the fibers had shrink and destroyed slightly. Second, the conveyer belt fabric preheat by far-infrared might caused the humidity on the fabric surface to drop fast, also removed the moisture content on the fabric and to get the dryness effect of the fabric. Third, after the fabric was heated by far-infrared heater, the broken strength of the fabric had decreased. Finally, heating 20 seconds and stop heating for 10 seconds then heat for 20 seconds, the beast treatment is adding Methylenediphenylisocyanate(MDI) for 8%, fabric and fabric adhesion strength is 16.73 kgf, fabric and rubber adhesion strength is18.70 kgf, fabric-fabric and fabric-rubber adhesion strength that improve 54.6%,69.6%. AcknowledgementsThe authors would like to thank the National Science Council for the financial support in this project References[1] M.D. Yang, W.H. Hsing and J.J. Juan: The Study on Adhesive Effect of PET/Nylon Conveyer BeltFabric Strengthen with Pre-heating and Cooling Device , Journal of the Hwa Gang Textile, V ol.8, No.3 (2001), p270-276. [2] Y .S. Huang, W.H. Hsing: The Study on Adhesive Effect of PET/Nylon Conveyer Belt FabricStrengthen by the Pre-heating and Cooling Device , Journal of the Hwa Gang Textile, V ol.9, No.3 (2002), p270-277.[3] D.G. Wang, W.H. Hsing and L.J. Run: The Study on Adhesive Effect of PET/Nylon Conveyer Belt Fabric Strengthen by Static Process , Journal of the Hwa Gang Textile, V ol.10, No.2 (2003), p125-133.[4] H.F. Chang, W.H. Hsing and L.J. Run, The Study on the Binding Effect of PET/Nylon ConveyerFabrics Threated by Microwave Irradiation, Journal of the Hwa Gang Textile, V ol.11, No.4 (2004), p331-337Applications of Engineering Materials10.4028//AMR.287-290Effect of Far-Infrared Pre-Heat Treatment and Adding Methylenediphenylisocyanate(MDI) on Adhesion Bonding between Reinforcement and Rubber of Conveyer Belt10.4028//AMR.287-290.2725。