一次性输液器具与输液安全
静脉输液治疗工具种类与选择应用王关芬
放、降 必泰过敏的
低感染 病人不能使
率
用
流速快、 适合快 速输液
价格较贵、 留置时间不 如硅胶导管 长
45
导管 名称
贝朗 外周 中心 静脉 导管
BD 外 周中 心静 脉导 管
材 型号
质
聚
氨
基
18G 、
甲
16G 、
酸
14G
乙
酯
1.9Fr 、 硅 3Fr 、 胶 4Fr 、
5Fr
长度 cm
留置 流速 时间 ml ／ h
16
中 心 静 脉 置 管（ CVC)
? 优点：管径粗、血流速度快、血流量大，插入导 管长度短、穿刺成功率高、输入速度快，不引起 血管壁刺激、并发症少，可测中心静脉压
? 缺点：气胸、出血、导管相关性感染、败血症等 并发症不可忽视； CRBSI 在 3% — 5% 导致住院时 间延长、费用增加。置管﹥ 5 天警惕感染
17G
粉红
0.32ml
150-275ml ／ h
17G
15G
绿色
0.39ml
300-500ml ／ h
15G
14G
灰色
0.44ml
600-1000ml ／h
15G
14G
灰色
0.3m l 每 200-350m l
个腔
／ h （腔） 49
巴德三向瓣膜式 PICC 规格
描述 / 规 可用长 导管内 生理盐水重力流 预冲容积 穿刺针规
优点
32 、 45 、 70
无明 确留 置时 间
V257 ： 600 V358 ： 2160
穿刺针 可第二 次见回 血、价 格便宜
50 、 65
一次性输液(血)器,注射器质量检查结果分析
·219·
一次性输液 (血) 器、注射器质量检查结果分析
韦 曦
(柳州市人民医院, 广西 柳州 545001)
摘要: 目的 为防止医源性感染, 了解本院一次性使用输液、输血器、注射器的质量情况。方法 对每批新进的各 厂家不同批号不同规格的产品按国家技术监督局颁布的 GB 标准进行无菌检查、细菌内毒素检查、溶出液性状检 查、化学性能分析。结果 无菌检查合格率: 一次性输液 (血) 器为 42. 9% , 一次性注射器为 96. 1% ; 细菌内毒素检 查合格率为 97. 5% ; 多数样品的溶出液均检出不同程度的色、白块及纤维等异物; 溶出液化学性能分析中一次性 使用输液 (血) 器的“还原物质”检查合格率仅为 28. 6% , 一次性使用注射器的“易氧化物”检查合格率仅为 15% ; 实验还证实多数输液 (血) 器有环己铜残留。 结论 国产一次性使用输液、输血器、注射器的产品质量及监督管理 力度急待提高。 关键词: 一次性输液 (血) 器; 注射器; 无菌检查; 细菌内毒素; 溶出液化学分析 中图分类号: R 197. 39 文献标识码: B 文章编号: 100524529 (2001) 0320219203
B G1581021995 规定一次性注射器易氧化物检 查: 高锰酸钾溶液消耗值应≤0. 5 m l。GB 8368283692 1998 规定一次性输液器、输血器“还原物质”检查高 酸钾溶液消耗值应≤2. 0 m l。 输液 (血) 器的溶出液紫外吸收光谱均有吸收峰 与环己酮溶液的最大吸收峰 (Κm ax276. 5 Λm ) 一致, 表 2、图 1。 2. 3. 3 环己酮残留量实验 目前国内多数厂家的 输液器的成型方法主要采用环己酮做粘合剂, 少数 厂家用热合法。 根据参考文献 1, 2 , 做化学性能检查 实验: 加热显气味法: 取供试液直接嗅其味或取供试 液置于试管中, 于酒精灯上加热至产生蒸汽时嗅及 环己酮的刺激性气味记+ ; 试液显色法: 根据环己
iso8536-42010医用输液器具-重力输液式一次性使用输液器
Reference number ISO 8536-4:2010(E)© ISO 2010INTERNATIONAL STANDARD ISO 8536-4Fifth edition 2010-10-01Infusion equipment for medical use — Part 4:Infusion sets for single use, gravity feedMatériel de perfusion à usage médical —Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravitéISO 8536-4:2010(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2010All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright officeCase postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@ Web Published in Switzerlandii © ISO 2010 – All rights reservedISO 8536-4:2010(E)Contents PageForeword (iv)1Scope (1)2Normative references (1)3General requirements (1)4Designation (4)4.1Infusion set (4)4.2Air-inlet device (4)5Materials (4)6Physical requirements (5)6.1Particulate contamination (5)6.2Leakage (5)6.3Tensile strength (5)6.4Closure-piercing device (5)6.5Air-inlet device (5)6.6Tubing (6)6.7Fluid filter (6)6.8Drip chamber and drip tube (6)6.9Flow regulator (6)6.10Flow rate of infusion fluid (6)6.11Injection site (6)6.12Male conical fitting (6)6.13Protective caps (6)7Chemical requirements (7)7.1Reducing (oxidizable) matter (7)7.2Metal ions (7)7.3Titration acidity or alkalinity (7)7.4Residue on evaporation (7)7.5UV absorption of extract solution (7)8Biological requirements (7)8.1General (7)8.2Sterility (7)8.3Pyrogenicity (7)8.4Haemolysis (7)8.5Toxicity (8)9Labelling (8)9.1Unit container (8)9.2Shelf or multi-unit container (8)10Packaging (9)Annex A (normative) Physical tests (10)Annex B (normative) Chemical tests (14)Annex C (normative) Biological tests (16)Bibliography (17)© ISO 2010 – All rights reserved iiiISO 8536-4:2010(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 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.This fifth edition cancels and replaces the fourth edition (ISO 8536-4:2007), of which it constitutes a minor revision. In detail, 7.1 was more clarified in alignment with B.2, and A.2.2 was changed in order to go back with the leakage test pressure to 20 kPa and to restrict the leakage test for (40 ± 1) °C.ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:⎯Part 1: Infusion glass bottles⎯Part 2: Closures for infusion bottles⎯Part 3: Aluminium caps for infusion bottles⎯Part 4: Infusion sets for single use, gravity feed⎯Part 5: Burette infusion sets for single use, gravity feed⎯Part 6: Freeze drying closures for infusion bottles⎯Part 7: Caps made of aluminium-plastics combinations for infusion bottles⎯Part 8: Infusion equipment for use with pressure infusion apparatus⎯Part 9: Fluid lines for use with pressure infusion equipment⎯Part 10: Accessories for fluid lines for use with pressure infusion equipment⎯Part 11: Infusion filters for use with pressure infusion equipment⎯Part 12: Check valvesiv © ISO 2010 – All rights reservedINTERNATIONAL STANDARD ISO 8536-4:2010(E)Infusion equipment for medical use —Part 4:Infusion sets for single use, gravity feed1 ScopeThis part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 Normative referencesThe 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 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirementsISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittingsISO 3696, Water for analytical laboratory use — Specification and test methodsISO 7864, Sterile hypodermic needles for single useISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness1) ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements2)3 General requirements3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated in Figure 2 used1) Under preparation. (Revision of ISO 14644-1:1999)2) To be published. (Revision of ISO 15223-1:2007)© ISO 2010 – All rights reserved1ISO 8536-4:2010(E)with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used for rigid containers.3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.Key1 protective cap of closure-piercing device 7 fluid filter2 closure-piercing device 8 tubing3 air inlet with air filter and closure 9 flow regulator4 fluid channel 10 injection site5 drip tube 11 male conical fitting6 drip chamber 12 protective cap of male conical fittinga Closure of the air inlet is optional.b The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has anominal pore size of 15 µm.c The injection site is optional.Figure 1 — Example of a vented infusion set2 © ISO 2010 – All rights reservedISO 8536-4:2010(E)Key1 protective cap of closure-piercing device 7 tubing2 closure-piercing device 8 flow regulator3 fluid channel 9 injection site4 drip tube 10 male conical fitting5 drip chamber 11 protective cap of the male conical fitting6 fluid filtera The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has anominal pore size of 15 µm.b The injection site is optional.Figure 2 — Example of a non-vented infusion set© ISO 2010 – All rights reserved3ISO 8536-4:2010(E)Key1 protective cap 4 clamp2 closure-piercing device or needle 5 air-inlet with air filter3 tubinga Other designs are acceptable if the same safety aspects are ensured.Figure 3 — Example of an air-inlet device4 Designation4.1 Infusion setInfusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the letter G:Infusion set ISO 8536-4 - IS - G4.2 Air-inlet deviceAir-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the letters AD:Air-inlet device ISO 8536-4 - IS - AD5 MaterialsThe materials from which the infusion set and its components are manufactured (as described in Clause 3) shall comply with the requirements specified in Clause 6. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8.4 © ISO 2010 – All rights reservedISO 8536-4:2010(E)6 Physical requirements6.1 Particulate contaminationThe infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of particles shall not exceed the contamination index limit.6.2 LeakageThe infusion set, when tested in accordance with A.2, shall show no signs of air leakage.6.3 Tensile strengthWhen tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.6.4 Closure-piercing deviceThe dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4.NOTE The dimension of 15 mm in Figure 4 is a reference measurement. The cross-section of the piercing device at this site is a circle.The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.Dimensions in millimetresFigure 4 — Dimensions of the closure-piercing device6.5 Air-inlet deviceThe air-inlet device shall conform to 3.2 and 8.2.The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into which the device is to be inserted.The air-inlet device shall be separate from, or integral with, the closure-piercing device.When the air-inlet device is inserted into a rigid infusion container, the air admitted into the container shall not become entrained in the liquid outflow.The air filter shall be fitted such that all air entering the rigid container passes through it, and such that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with A.4.© ISO 2010 – All rights reserved5ISO 8536-4:2010(E)6.6 TubingThe tubing, made of flexible material, shall be transparent or sufficiently translucent that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision.The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length, including the injection site, when provided, and the male conical fitting.6.7 Fluid filterThe infusion set shall be provided with a fluid filter.When tested in accordance with A.5, the retention of latex particles on the filter shall be not less than 80 %. 6.8 Drip chamber and drip tubeThe drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip chamber through a tube that projects into the chamber. There shall be a distance of not less than 40 mm between the end of the drip tube and the outlet of the chamber, or a distance of not less than 20 mm between the drip tube and the fluid filter. The wall of the drip chamber shall not be closer than 5 mm to the end of the drip tube. The drip tube shall be such that 20 drops of distilled water or 60 drops of distilled water at (23 ± 2) °C at a flow rate of (50 ± 10) drops/min deliver a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g. The drip chamber should permit and facilitate the priming procedure.6.9 Flow regulatorThe flow regulator shall adjust the flow of the infusion solution between zero and the maximum. The flow regulator should be capable of continuous use throughout an infusion without the tubing being damaged. There should be no deleterious reaction between the flow regulator and the tubing when they are stored in such a way that there is contact.6.10 Flow rate of infusion fluidThe infusion set shall deliver not less than 1 000 ml of a sodium chloride solution [mass concentration ρ(NaCl) = 9 g/l] in 10 min under a static head of 1 m.6.11 Injection siteWhen provided, the self-sealing injection site shall reseal when tested in accordance with A.6, and there shall be no leakage of more than one falling drop of water. The injection site should be located near the male conical fitting.6.12 Male conical fittingThe distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 594-1 or ISO 594-2. Luer lock fittings in accordance with ISO 594-2 should preferably be used.6.13 Protective capsThe protective caps at the end of the infusion set shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the infusion set. Protective caps should be secure but easily removable.6 © ISO 2010 – All rights reserved7 Chemical requirements7.1 Reducing (oxidizable) matterWhen tested in accordance with B.2, the difference of volume of Na2S2O3 solution [c(Na2S2O3) = 0,005 mol/l] for the extract solution S1 and of volume of Na2S2O3 solution for blank solution S0 shall not exceed 2,0 ml. 7.2 Metal ionsThe extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead and tin, and not more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an equivalent method.When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not exceed that of the standard matching solution with a mass concentration ρ(Pb2+) = 1 µg/ml.7.3 Titration acidity or alkalinityWhen tested in accordance with B.4, not more than 1 ml of either standard volumetric solution shall be required for the indicator to change to the colour grey.7.4 Residue on evaporationWhen tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.7.5 UV absorption of extract solutionWhen tested in accordance with B.6, the extract solution S1 shall not show absorption greater than 0,1.8 Biological requirements8.1 GeneralThe infusion set shall be assessed for biological compatibility according to the guidelines given in C.2.8.2 SterilityThe infusion set or the air-inlet device, or both, in its unit container shall have been subjected to a validated sterilization process (see ISO 11135, ISO 11137 and ISO 17665).8.3 PyrogenicityThe infusion set and/or the air-inlet device shall be assessed for freedom from pyrogens by using a suitable test, and the results shall indicate that the infusion set is free from pyrogens. Guidance on testing for pyrogenicity is given in C.1.8.4 HaemolysisThe infusion set shall be assessed for freedom from haemolytic constituents and the result shall indicate that the infusion set is free from haemolytic reactions. Guidance on testing for haemolytic constituents is given in ISO 10993-4.© ISO 2010 – All rights reserved78.5 ToxicityMaterials shall be assessed for toxicity by carrying out suitable tests, and the results of the tests shall indicate freedom from toxicity. Guidance on testing for toxicity is given in ISO 10993-1.9 Labelling9.1 Unit containerThe unit container shall be labelled with at least the following information:a) a textual description of the contents, including the words “Gravity feed only”;b) indication that the infusion set is sterile, using the graphical symbol as given in ISO 15223-1;c) indication that the infusion set is free from pyrogens, or that the infusion set is free from bacterialendotoxins;d) indication that the infusion set is for single use only, or equivalent wording, or using the graphical symbolin accordance with ISO 15223-1;e) instructions for use, including warnings, e.g. about detached protective caps;NOTE Instructions for use can also take the form of an insert.f) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol in accordance withISO 15223-1;g) year and month of expiry, accompanied by appropriate wording or the graphical symbol in accordancewith ISO 15223-1;h) the manufacturer's or supplier's name and address, or both;i) a statement that 20 drops of distilled water or 60 drops of distilled water delivered by the drip tube areequivalent to a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g;j) the nominal dimensions of the intravenous needle, if included.9.2 Shelf or multi-unit containerThe shelf or multi-unit container, when used, shall be labelled with at least the following information:a) a textual description of the contents, including the words “Gravity feed only”;b) the number of infusion sets;c) indication that the infusion sets are sterile, using the graphical symbol as given in ISO 15223-1;d) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol in accordance withISO 15223-1;e) year and month of expiry, accompanied by appropriate wording or the graphical symbol in accordancewith ISO 15223-1;f) the manufacturer's and/or supplier's name and address;g) the recommended storage conditions, if any.10 Packaging10.1 The infusion set and/or the air-inlet device shall be individually packed so that they remain sterile during storage. The unit container shall be sealed in a tamper-evident manner.10.2 The infusion sets and/or the air-inlet devices shall be packed and sterilized in such a way that there are no flattened portions or kinks when they are ready for use.© ISO 2010 – All rights reserved9Annex A(normative)Physical testsA.1 Test for particulate contaminationA.1.1 PrincipleThe particles are rinsed from the inner fluid pathway surfaces of the infusion set, collected on a membrane filter and microscopically counted.A.1.2 Reagents and materialsA.1.2.1 Distilled water,filtered through a membrane of pore size 0,2 µm.A.1.2.2 Non-powdered gloves.A.1.2.3 Vacuum filter, single membrane filter of pore size 0,45 µm.A.1.3 ProcedureThe filter unit, filter and all other equipment shall be thoroughly cleaned before the test using distilled water (A.1.2.1).Flush through 10 ready-to-use infusion appliances, under laminar flow conditions (clean-air work station class N5 in accordance with ISO 14644-1), with 500 ml of distilled water (A.1.2.1). The total volume is subsequently vacuum filtered (A.1.2.3). Place the particles on the membrane screen filter under a microscope at ×50 magnification using diagonally incident illumination, and measure and count in accordance with the size categories given in Table A.1.A.1.4 Determination of resultsA.1.4.1 GeneralAn appropriate number of single infusion sets (minimum of 10) are tested. The number of particles per10 infusion sets tested in each of the three size categories is the assay result.A.1.4.2 Particle countsThe values obtained from a blank control sample shall be recorded in a test report and taken into account when calculating the contamination index limit.The blank control sample is the number and size of particles obtained from 10 equivalent 500 ml water samples classified in accordance with the three size categories set out in Table A.1, using the same test equipment but not passed through the appliances under test.The number of particles in the blank, N b, shall not exceed the value of 9. Otherwise, the test apparatus shall be disassembled, re-cleaned, and the background test performed again. Values of the blank determination shall be noted in the test report.Table A.1 — Evaluation of contamination by particlesSize categoryParticle parameters1 2 3 Particle size in µm 25 to 50 51 to 100 over 100Number of particles in 10 infusion appliances n a1n a2n a3Number of particles in the blank control sample n b1n b2n b3Evaluation coefficient 0,1 0,2 5The contamination index limit is calculated as follows.For each of the three size categories, multiply the number of particles in 10 infusion appliances by the evaluation coefficients, and add the results in order to obtain the number of particles in the infusion appliances(test pieces), N a. Then, for each of the size categories, multiply the number of particles in the blank control sample by the evaluation coefficients and add the results to obtain the number of particles in the blank sample,N b.Subtract N b from N a to obtain the contamination index limit.Number of particles in the infusion appliances (test pieces):N a=n a1× 0,1 +n a2× 0,2 +n a3× 5Number of particles in the blank sample:N b=n b1× 0,1 +n b2× 0,2 +n b3× 5Contamination index limit:N=N a−N b u 90A.2 Test for leakageA.2.1 At the beginning of the test, condition the whole system at the test temperature.A.2.2 Immerse the infusion set, with one end blocked, in water at (40 ±1) °C and apply an internal air pressure of 20 kPa for 15 s. Examine the infusion set for air leakage.A.2.3 Fill the infusion set with degassed, distilled water, connect it with its openings sealed to a vacuumdevice and subject it to an internal excess pressure of −20 kPa at (40 ± 1) °C for 15 s. Atmospheric pressureshall be the reference pressure. Excess pressure, in accordance with ISO 80000-4, can assume positive or negative values. Ascertain whether air enters the infusion set.A.3 Test for tensile strengthExpose the infusion set to be tested to a static tensile force of 15 N applied along the longitudinal axis for 15 s. Inspect whether the infusion set withstands the test force applied.© ISO 2010 – All rights reserved11A.4 Determination of flow rate when using an air-inlet deviceA.4.1 Fill an infusion container with distilled water at (23 ± 2) °C and insert its closure. Insert the air-inlet device through the closure into the container and then insert the infusion set with the flow regulator set, such that no liquid flows. Arrange the container to give the equivalent of a pressure of 1 m head of water throughout the test. Open the flow regulator of the infusion set to maximum and measure the rate of flow of water from the set. Repeat the procedure with the filter removed from the air-inlet device.A.4.2 For air-inlet devices integral with the closure-piercing device of the infusion set, follow the procedure given in A.4.1 but omit the insertion of the separate air-inlet device.A.5 Test for efficiency of the fluid filterA.5.1 Preparation of the test fluidAs a test liquid, use an aqueous suspension of latex particles with a diameter of (20 ± 1) µm and a concentration of approximately 1 000 particles per 100 ml.A.5.2 ProcedureAssemble the fluid filter and position it so that it is equivalent to that of actual use in a suitable test apparatus in accordance with Figure A.1. Cut the tubing of the infusion set approximately 100 mm below the fluid filter. Flush the fluid filter with 5 ml of the test fluid from the storage bottle and discard the filtrate. Pass 100 ml of the test fluid through the fluid filter and collect the effluent under vacuum after passing it through a black gridded membrane filter with a pore size of 5 µm to 8 µm and 47 mm diameter. Mount the membrane with any retained latex particles on a suitable microscope slide or holder and count the latex particles in a minimum of 50 % of the grid squares under a magnification of ×50 to ×100. Disregard any particles which are obviously non-latex.Carry out the test in duplicate.Repeat the test if the required limit value of 80 % retention rate is not met.All procedures involved in this test should be conducted in a clean environment, if possible under laminar flow.A.5.3 Expression of results The retention rate of the filter, expressed as a percentage, is given by101100n n ⎛⎞−×⎜⎟⎝⎠ (A.1)wheren 1 is the number of particles retained on the filter;n 0 is the number of particles in the test fluid used.Dimensions in millimetresKey1 storage bottle 5 piercing device2 transfer tube 6 fluid filter3 flow regulator 7 membrane filter4 connecting pieceFigure A.1 — Apparatus for testing the efficiency of the fluid filterA.6 Test of the injection sitePlace the injection site in a horizontal, stress-free position. Fill the infusion set with water in such a manner that no air bubbles are trapped and apply a pressure of 50 kPa above the atmospheric air pressure. Perforate the injection site at the foreseen area using a hypodermic needle with an outside diameter of 0,8 mm and which conforms to ISO 7864. Keep the needle in position for 15 s. Remove the needle and immediately dry the perforated site. Over a period of 1 min, observe whether there is any leakage from the injection site. In the case of an alternative injection site design, the test should be performed by injection into the site in accordance with the instructions provided by the manufacturer.© ISO 2010 – All rights reserved13。
湖南省药品监督管理局关于执行国家标准《一次性使用输液器重力输液器》(GB8368-2018)的通知
湖南省药品监督管理局关于执行国家标准《一次性使用输液器重力输液器》(GB8368-2018)的通知
文章属性
•【制定机关】湖南省药品监督管理局
•【公布日期】2021.08.10
•【字号】湘药监函〔2021〕67号
•【施行日期】2021.08.10
•【效力等级】地方规范性文件
•【时效性】现行有效
•【主题分类】卫生医药、计划生育其他规定
正文
湖南省药品监督管理局
关于执行国家标准《一次性使用输液器重力输液器》
(GB8368-2018)的通知
湘药监函〔2021〕67号
省局各相关处室、局直单位，各市、州市场监管局，相关医疗器械生产、经营企业和使用单位：
国家标准《一次性使用输液器重力输液器》(GB 8368-2018，以下简称新标准)已于2018年3月15日发布，2021年4月1日开始实施。
为进一步推动新标准实施，现就有关事项通知如下：
一、相关医疗器械生产企业应当严格执行新标准。
2021年4月1日后生产的“一次性使用的、与输液容器和静脉器具配合使用的重力输液式输液器”产品必须
符合《一次性使用输液器重力输液器》(GB 8368-2018）的规定。
二、各医疗器械经营企业、使用单位要积极推广使用新标产品。
2021年4月1日后生产的不符合新标准的产品，经营企业、使用单位一律不得经营、使用。
湖南省药品监督管理局
2021年8月10日。
输液室工作流程及操作标准
输液室工作流程及操作标准介绍输液室是医院中重要的部门之一，负责为患者提供输液治疗。
本文档介绍了输液室的工作流程和操作标准，旨在确保输液过程的安全和有效性。
工作流程1. 患者信息登记：患者到达输液室后，工作人员应仔细核对其个人信息，包括姓名、年龄、病历号等，并录入电子系统。
2. 输液准备：根据医嘱，工作人员应准备需要的输液液体和输液器具。
在准备过程中，严格遵循无菌操作规范。
3. 输液过程：将准备好的输液液体连接到输液器具上，并通过静脉通道输送给患者。
工作人员应监测输液速度和患者的病情反应，确保输液的安全和有效。
4. 数据记录：在输液过程中，工作人员应及时记录输液开始和结束的时间、输液液体的种类和剂量等关键信息。
5. 输液结束：当医嘱或输液液体用完时，工作人员应停止输液，并及时将输液器具和一次性医用物品进行妥善处理。
6. 患者离开：患者完成输液后，工作人员应帮助其整理好个人物品，并解答其可能存在的疑问。
操作标准1. 无菌操作：在准备和执行输液过程中，工作人员应穿戴干净的服装、戴好口罩和手套，并采用无菌巡房或送药方式，确保输液器具和液体的无菌状态。
2. 设备检查：每次使用输液器具前，工作人员应检查其完整性和有效性，包括输液袋密封情况、管路连接是否紧固等。
3. 输液速度：根据医嘱和患者的需要，工作人员应调整输液速度，并定期检查输液速度的准确性。
4. 病情观察：在输液过程中，工作人员应密切观察患者的生命体征和不良反应，如发现异常情况应立即报告医生。
5. 记录完整：工作人员应准确记录输液开始和结束的时间、液体种类、剂量等关键信息，并及时上报相关部门。
6. 一次性物品处理：输液结束后，工作人员应将一次性输液器具和废弃物按医院规定进行分类、处理或回收。
以上是输液室工作流程及操作标准的简要介绍，务必保证操作的准确性和规范性，以确保患者的安全和治疗效果。
安全输液管理PPT课件
安全输液管理ppt课件目录CONTENCT •安全输液概述•输液器具选择与使用•药品配置与保存•输液操作规范与流程•并发症预防与处理•患者教育与心理支持•质量监控与持续改进01安全输液概述定义与重要性定义安全输液是指在医疗过程中，通过采取一系列措施，确保输液治疗的安全性，防止输液过程中可能出现的各种风险和并发症。
重要性安全输液是医疗安全的重要组成部分，直接关系到患者的生命安全和身体健康。
提高安全输液水平，有助于减少医疗差错和纠纷，提升医疗质量和服务水平。
国内外现状及发展趋势国内现状01近年来，我国医疗行业对安全输液的重视程度不断提高，相关法规和标准逐步完善。
但在实际操作中，仍存在一些问题，如输液操作不规范、输液反应处理不及时等。
国外现状02发达国家在安全输液方面起步较早，建立了完善的法规和标准体系，对输液治疗的全过程进行严格监管。
同时，重视医护人员的教育和培训，提高其安全意识和操作技能。
发展趋势03随着医疗技术的不断进步和患者安全意识的提高，安全输液将更加注重个体化、精准化和智能化。
未来，将借助大数据、人工智能等技术手段，实现输液治疗的精准监测和智能管理。
相关法规与标准国家层面法规《医疗事故处理条例》、《医疗质量管理办法》等法规对安全输液提出了明确要求，规定了医疗机构和医护人员在输液治疗中的职责和义务。
行业层面标准《静脉治疗护理技术操作规范》、《临床静脉用药调配与使用指南》等标准规范了静脉输液的操作流程、药物调配、并发症处理等方面的内容，为医护人员提供了具体的操作指南。
02输液器具选择与使用01020304一次性输液器精密过滤输液器避光输液器静脉留置针输液器具种类及特点适用于需要避光输注的药物，如硝普钠等。
在输液过程中能有效滤除药液中的微粒，降低输液反应的发生率。
采用医用高分子材料制造，具有使用方便、安全卫生等特点。
可减轻患者反复穿刺的痛苦，适用于长期输液或血管条件较差的患者。
输液器具选择原则根据患者年龄、病情、血管条件及药物性质等因素选择合适的输液器具。
一次性输液器的新用途
一次性输液器的新用途
一次性输液器是采用医用无菌高分子材料制造,经环氧乙烷灭菌,无菌、无毒、无致热源的医疗器材,是目前临床广泛用于静脉输液的用具。
作者试用一次性输液器除用于输液外,还发现有更多新用途。
灌肠:将一次性输液器撕开单包装袋,取下护套,将瓶塞穿刺器垂直插入配制好的倒挂灌肠液瓶胶塞中央,使排气管向上,打开流量调节器,排除管内空气。
用剪刀剪去输液管过滤器械,管末涂上少许液状石腊油润滑,插入肛门10～15cm即可用于各种灌肠。
导尿:将一次性输液器撕开单包装袋,术者戴无菌乳胶手套,用无菌剪刀剪去过滤器及莫菲管,管末端涂上少许液状石蜡油,插入尿道口即可代替导尿管用于导尿。
胸腔闭式引流:将一次性输液器撕开单包装袋,术者戴无菌乳胶手套,用无菌剪刀剪去过滤器及莫菲氏管,在头端侧壁每相距1cm不同方向剪1～3個引流孔,剪去管壁的约1/3,引流通畅,从胸腔套管针中送入胸腔即可做闭式引流管使用(注意剪孔不宜过大,以免拔除管子时断裂,残留胸腔)。
吸痰:将输液管剪去莫菲管及过滤器剪成40cm 1节,接上注射器或电动吸痰器即可代替吸痰管。
讨论
在基层医院工作中,灌肠、导尿、引流、吸痰等是经常碰到的临床小技术,使用工具的简便将对抢救病人赢得时间,给病人减少痛苦。
作者几年来将一次性输液器稍加改良用于上述几个用途从未发生过任何不良反应,既方便省时,又节约好用。
在一次性输液器物价廉美广泛应用的今天,稍加改良即可应用于临床工作,很适合广大基层医生推广使用。
静脉输液治疗工具种类与选择
12 15 20
、 、 、
14G 30
无明 确留 置时
间
流速快、 使用后血管
V330 导 管 2400
适合快 速输液、 价格便
易收缩变硬， 留置时间不 如硅胶导管
宜
长
44
导管 材 型 长度 留置 流速 名称 质 号 cm 时间 ml ／ h
优点
缺点
聚
Arrow 中心
静脉 导管
脲 氨 酯 类
16G
20
? 留置时间： 72-96h
8
外周静脉留置针
? 优点：套管柔软，容易固定，操作方便，减少渗 漏，利于患者活动，便于紧急抢救
? 缺点：输入刺激性药物时，会引起渗漏性损伤和 化学性静脉炎，不能保护血管
9
中心静脉导管
? 20 世纪 50 年代，随着病人对中长期输液的要求越 来越多，人们认识到将液体直接输注到上腔静脉 要比通过外周静脉输注的效果好。通过外周放置 导管的技术也得到了不断的发展
长度 cm
1.9 、 2.5 3.0
留置 流速 时间 ml ／ h
优点
缺点
3— 天
4
（ 22G.2 4G ） 1140 —
1980
操作简 便、单 次价格 低廉 、 速度快、 感染率
低
留置时间短、 易发生外渗、 静脉炎、药 物可能过分 刺激外周血
管
贝朗 中心 静脉 导管
聚 氨 酯 类
18G 16G
、 、
成人术后肠外营养和早产儿营养
12
13
外周中心静脉置管
? 1978 年， Dr Leroy Groshong 一位肿瘤外科医生 发明了三向瓣膜式装置，并命名为 Groshong 导管 （中国称为：三向瓣膜式 PICC ）
一次性使用流量设定微调式输液器(产品介绍)
北京高思明创科技有限公司 Beijing Gauss Create & Technology Co.,Ltd
流量设定微调试调节器： 此产品使用在重力输液器上，与传统的调节器相比实现微量调节和稳定调节的优越性。 此微量调解器可以实现 24 小时以一定设定量的输液，达到提高药效及无副作用的效果。 可以向 ICU 重症监护病房、手术室、急诊室、麻痹课以及需要各种精确输液的使用。 对于无需压力注射的精确输液，在一定程度上可以取代电脑输液泵。 • 世界上首次实现单手操作； 使用方便 • OPEN/OFF；开/关迅速 无需 360 度旋转 • 安全 Safety Bar ； OPEN 与 OFF 之间预设卡槽防止医疗事故 • 可调范围广(5~300 ㎖/h)； • 精确设计 流量偏差小，精确度高； • 设计单一油路 便于单手操作，高密封性确保流量的准确性； • 完成品组装后微量调节器与软管互不转动； • 无过量输入的危险，保持输液流量的不变，无需经常照看； • 流量显示在仪表盘式刻度盘(Indicator)上，安装及操作简单快捷，安全可靠，减轻患者恐惧感 无需专门培训；
确，流量恒速，提高药物的安全性和有效性。大大减少护士操作时间，充分节省巡回时间，增加与患者与家属进行沟通机会建立良好
的护患关系，提高患者对护士的满意度。
临床上有些静脉输液药物比如肿瘤化疗等输液时，需要输液的恒定性与精确性，避免产生不良反应。如果输液速度过快，可使循环
血量突然增加，加重心脏负担，引起心力衰竭和肺水肿；如导致药物的血药浓度升高过快，超出安全范围，产生毒副作用。而输注药
北京高思明创科技有限公司 Beijing Gauss Create & Technology Co.,Ltd
微调式输液器
此产品为进口高档一次性流量设定输液器（无针）产品，已经在世界各地（美国，欧洲，非洲等）销售受到各医疗机构的亲睐。 国际认证：ISO13485,ISO9001,KGMP 各国认证：FDA,CE,SFDA,KFDA
54号令
关于实施《医疗器械生产质量管理规范（试行）》及其配套文件有关问题的通知国食药监械[2011]54号2011年01月27日发布各省、自治区、直辖市食品药品监督管理局（药品监督管理局），国家食品药品监督管理局药品认证管理中心：《医疗器械生产质量管理规范（试行）》（以下简称《规范》）及其检查管理办法、无菌和植入性医疗器械实施细则等配套文件已经发布，并自2011年1月1日起实施。
为做好实施工作，现就有关问题通知如下：一、自2011年1月1日起，无菌医疗器械和植入性医疗器械执行《规范》的有关规定。
其他医疗器械品种执行《规范》的具体时间另行通知。
二、《医疗器械生产质量管理规范检查管理办法（试行）》第二条规定的“部分高风险第三类医疗器械”，其《规范》检查结论为“整改后复查”的，生产企业的复查申请和整改报告直接向国家食品药品监督管理局药品认证管理中心提交。
该办法第二十四条规定的“在其正式生产后6个月内”，是指生产企业取得产品注册证后6个月内。
三、《关于印发医疗器械生产质量管理规范无菌医疗器械实施细则和检查评定标准（试行）的通知》（国食药监械〔2009〕835号）第四条中“在本通知发布前根据相关文件规定应执行《一次性使用无菌医疗器械产品（注、输器具）生产实施细则（2001年修订）》的一次性使用无菌医疗器械产品（注、输器具）”是指：一次性使用无菌注射针、一次性使用静脉输液针、一次性使用输液器、一次性使用输血器、一次性使用无菌注射器、一次性使用塑料血袋、一次性使用采血器、一次性使用滴定管式输液器、一次性使用胰岛素注射器、一次性使用自毁式注射器、一次性使用加药式注射器、一次性使用避光式输液器、一次性使用袋式输液器、一次性使用紫外线照射输液器、一次性使用透明式输液器、一次性使用降解材料输液器、一次性使用采血器（新式），其他一次性使用注射器、输液器产品（即基本结构、功能属于或可归于输液器、注射器的一次性使用无菌医疗器械）。