一次性使用输液器标准
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。
医用输血输液注射器具 标准
医用输血输液注射器具标准
医用输血输液注射器具标准是确保医疗器械质量和安全性的重
要标准之一。
这些标准涵盖了输血输液注射器具的设计、材料、生
产和使用过程中的各个环节，以确保其符合医疗行业的要求和规定。
首先，医用输血输液注射器具的设计必须符合人体工程学原理，保证患者在接受输血输液或注射时的舒适度和安全性。
同时，注射
器具的材料必须符合医疗器械的相关标准，具有良好的生物相容性
和耐用性，以确保在使用过程中不会对患者造成任何不良影响。
其次，生产过程中需要严格控制产品的质量，确保每一支输血
输液注射器具都符合规定的标准和要求。
这包括原材料的选择、生
产工艺的控制、产品的检测和质量管理等方面，以确保产品的安全
性和可靠性。
此外，医用输血输液注射器具的使用过程中也需要遵循相关的
标准和规定，包括正确的操作方法、产品的储存和保养等方面，以
确保产品在使用过程中能够发挥最佳的效果，并且不会对患者造成
任何不良影响。
总之，医用输血输液注射器具标准的制定和执行，对于保障患
者的安全和健康具有重要意义，也是医疗器械行业的一项重要工作。
只有通过严格的标准和规范，才能够确保输血输液注射器具的质量
和安全性，为患者提供更加可靠和有效的医疗服务。
一次性使用肠内营养输注器产品技术要求
一次性使用肠内营养输注器适用范围：用于肠内营养输注。
1.1 一次性使用肠内营养输注器分类代号为SK,按输注动力不同分为重力输注式（分类标记：“G”）和泵输注式（分类标记：“P”），按连接方式不同分为穿刺式（分类标记：“C”）、卡式（分类标记：“K”）和袋式（分类标记：“D”），所有规格型号见表1。
表规格型号分类1.2材料：一次性使用肠内营养输注器主要山聚氯乙烯（PVC）和丙烯月青-丁二烯-苯乙烯（ABS）材料制成。
聚氯乙烯中使用的增塑剂是DINCH,不含DEHP1.3组成1・3. 1穿刺连接式山瓶塞穿刺器、瓶塞穿刺器保护套、进气器件、管路、滴斗、硅胶管、二通、流量调节器、注射件、Y形三通、内圆锥接头、连接件及其保护套等各部件组成。
基本组成示意图见图1。
图1 一次性使用肠内营养输注器（穿刺式）示例1.3.2袋式山储液袋、水止、管路、滴斗、硅胶管、二通、流量调节器、注射件、 Y 形三通、内圆锥接头、连接件及其保护套等各部件组成。
基本组成示意图见图 2。
2-瓶塞穿刺器3-进气器件 4-滴斗5-硅胶管6-二通 7-流 量调节器 8-管路9-注射件IO-Y 形三通11-内圆锥接头 12-连接件 13-保护套注：硅胶管可在其它位置，二通可为其它方式,重力式可不带硅胶管。
1-瓶塞穿刺器保护套管 5-二通6-流量调节器 7-管路 8-注射件9-Y 形三通10-内圆锥接头11-连接件12-保护套注：硅胶管可在其它位置，二通可为其它方式，重力式可不带硅胶管。
图2 —次性使用肠内营养输注器（袋式）示例1.3.3卡式曲卡式连接件、进气器件、管路、滴斗、硅胶管、二通、流量调节器、 注射件、Y 形三通、内圆锥接头、连接件及其保护套等各部件组成。
基本组成示 意图见图3。
12-保护套注：硅胶管可在其它位置，二通可为其它方式，重力式可不带硅胶 管。
图3 —次性使用肠内营养输注器（卡式）示例注：硅胶管和二通为泵输注式的组件。
1-储液袋 2-水止 3-滴斗 4-硅胶1-进气器件2-卡式连接件3-滴斗4-硅胶 6-流量调节器7-管8-注射件9-Y 形三通 10-内圆锥接头11-连接件S2. 1物理要求2. 1. 1外观肠内营养输注器以Ll力及手感检查不应有明显的斑点、朵质、划痕等缺陷。
GB15980-1995一次性使用医疗用品卫生标准
【GB 15980—1995】一次性使用医疗用品卫生标准根据《中华人民共和国传染病防治法》及《中华人民共和国传染病防治法实施方法》，特制定本标准。
1 主题内容与适用范围本标准规定了一次性使用医疗用品灭菌、消毒前、后的卫生标准。
本标准对一次性使用医疗用品（包括灭菌的和消毒的一次性使用医疗用品）生产企业中生产、装配、包装车间等生产过程和生产工人手提出卫生要求的质量控制。
本标准适用于各类一次性使用医疗用品生产企业，也适用于灭菌与消毒服务单位。
2 引用标准GB 7918．2 化妆品微生物标准检查方法GB 8368 一次性使用输液器GB 8369 一次性使用输血器GBJ 4883 医院污水排放标准（试行）中华人民共和国药典（1990年版）3 术语3．1 灭菌：用物理或化学方法杀灭传播媒介上所有的微生物，使其达到无菌。
3．2 消毒：用物理或化学方法杀灭或清除传播媒介上的病原微生物，使其达到无害化。
3．3 灭菌的一次性使用医疗用品：进入人体组织，无菌、无热源、无溶血反应和无异常毒性检验合格，出厂前必须经灭菌处理的可直接使用的一次性使用医疗用品。
3．4 消毒的一次性使用医疗用品：接触皮肤、粘膜，无毒害检验合格，出厂前必须经过消毒处理可直接使用的一次性使用医疗用品。
4 灭菌与消毒标准4．1 一次性使用医疗用品产品必须用环氧乙烷或电离辐射或其他经卫生部审查合格的方法进行灭菌和消毒。
所用灭菌与消毒设备必须有产品合格证和卫生许可证。
4．2 一次性医疗用品产品经环氧乙烷灭菌或消毒出厂时，环氧乙烷残留量不大于10μg/g。
4．3 灭菌与消毒的微生物指标：4．3．1 产品初始污染菌数：灭菌产品管道类内腔≤10cfu/件次，外部≤100cfu/件次；非管道类≤100cfu/件次；敷料类≤100cfu/g；消毒产品≤1000cfu/件次或重量（g）。
4．3．2 灭菌与消毒产品均不得检出致病菌。
4．3．3 生产、装配、包装车间空气细菌总数，灭菌与消毒产品分别≤500和2000cfu/m3；物体表面细菌总数分别≤10和20cfu/cm2。
输液器标准
医疗器械注册产品标准YZB/国—2012代替YZB/国—2006一次性使用输液器带针2012-01-05发布2012-01-26实施上海XX医疗器械有限公司发布前言本标准中的带针是指一次性使用输液器带静脉输液针。
本标准采用GB8368—2005《一次性使用输液器重力输液式》和GB 18671-2009《一次性使用静脉输液针》要求编写。
GB 8368—2005中的附录A、附录B、附录C、附录NA、附录NB和GB18671-2009中所有附录A、附录B、附录C、附录D都适用于本标准。
本标准提出了出厂检验要求。
本标准由上海XX医疗器械有限公司提出。
本标准由上海XX医疗器械有限公司生产技术部归口。
本标准由上海XX医疗器械有限公司生产技术部起草。
本标准主要起草人：XX本标准所替代标准的历次版本发布情况为：————YZB/国XXXX—2006一次性使用输液器带针1范围本标准规定了一次性使用输液器带针的要求。
2规范性引用标准下列标准所包含的条文，通过在本标准引用而构成为本标准的条文。
本标准出版时，所示标准均为有效。
所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。
GB/T 1962.1-2001 注射器、注射针及其他医疗器械6%锥度（鲁尔）圆锥接头第1部分：通用要求（GB/T 1962.1-2001,idt ISO 594-2:1998）GB/T 1962.2 -2001 注射器、注射针及其他医疗器械6%锥度（鲁尔）圆锥接头第2部分：锁定锥头（GB/T 1962.2-2001,idt ISO 594-2:1998）GB/T 14233.1-2008 医用输液、输血、注射器具检验方法第1部分：化学分析法GB/T 14233.2-2005 医用输液、输血、注射器具检验方法第2部分：生物学试验方法GB18671-2009 一次性使用静脉输液针YY 0466-2003 医疗器械用于医疗器械标签、标记和提供信息的符号（YY 0466-2003，ISO 15233:2000,IDT）GB/T 2828.1-2003 逐步检查计数抽样程序及抽样表（适用于连续批得检查）GB 8368-2005 一次性使用输液器重力输液式GB/T 14437-1997 产品质量计数一次监督抽样检验程序（适用于总体量较大的情形）GB/T 16886.1-2001 医疗器械生物学评价第1部分：评价与试验GB 18457-2001 制造医疗器械用不锈钢针管YY/T 0313-1998 医用高分子产品包装、标志、运输和贮存3通用要求和结构3.1输液器组件的名称如图1至图14所示。
一次性注射器输液器的规范化管理
一次性注射器输液器的规范化管理.doc一次性注射器和输液器的规范化管理引言本文档旨在规范一次性注射器和输液器的管理流程，确保医疗安全和质量，防止交叉感染。
第一章总则第一条目的制定本管理规范的目的是为了确保一次性注射器和输液器的安全使用，提高医疗服务质量。
第二条适用范围本规范适用于所有医疗机构中一次性注射器和输液器的采购、储存、使用和废弃处理。
第三条管理原则一次性注射器和输液器的管理应遵循以下原则：安全性：确保使用过程中的医疗安全。
有效性：确保注射器和输液器的性能满足医疗需求。
合规性：遵守国家相关法律法规和标准。
经济性：合理控制成本，避免浪费。
第二章采购管理第四条供应商选择选择合格的供应商，确保产品来源合法、质量合格。
第五条采购流程制定采购计划，明确需求量和规格。
进行市场调研，比较不同供应商的产品和价格。
签订采购合同，明确质量标准和交货期限。
第六条质量检验对采购的一次性注射器和输液器进行质量检验，确保产品合格。
第三章储存管理第七条储存条件确保储存环境干燥、清洁、避光，符合产品储存要求。
第八条储存管理建立储存管理制度，明确储存条件和期限。
定期检查库存，确保产品未过期或损坏。
第九条标识管理对储存的一次性注射器和输液器进行明确标识，包括生产批号、有效期等信息。
第四章使用管理第十条使用规范严格按照医疗操作规程使用一次性注射器和输液器。
确保一人一用，避免交叉感染。
第十一条使用记录建立使用记录，记录使用时间、患者信息、使用人员等。
第十二条异常处理发现产品异常时，立即停止使用，并进行相应的处理。
第五章废弃处理第十三条废弃标准制定废弃处理标准，明确何种情况下产品需废弃。
第十四条废弃流程将废弃的一次性注射器和输液器进行分类收集。
按照医疗废物处理规定进行安全处理。
第十五条废弃记录建立废弃记录，记录废弃时间、数量、处理方式等信息。
第六章监督管理第十六条定期检查定期对一次性注射器和输液器的管理情况进行监督检查。
第十七条培训与教育对医护人员进行一次性注射器和输液器使用和管理的培训。
一次性使用无菌医疗器械监督管理办法
罚则
生产不符合国家标准或行业标准的无菌器械的依
据医疗器械监督管理条例第三十七条处罚
37条违反本条例规定生产不符合医疗器械国家标准或 者行业标准的医疗器械的由县级以上人民政府药品监
督管理部门予以警告责令停止生产没收违法生产的产
品和违法所得违法所得5000元以上的并处违法所得2 倍以上5倍以下的罚款；没有违法所得或者违法所得 不足5000元的并处5000元以上2万元以下的罚款；情 节严重的由原发证部门吊销产品生产注册证书；构成
使用的监督
一从生产企业采购无菌器械应验明生产企业销售人员出 具的证明所出具证明的内容按第七条规定
二从经营企业采购无菌器械应验明经营企业销售人员出 具的证明所出具证明的内容按第十七条规定
第二十二条 医疗机构应建立无菌器械使用后销毁 制度使用过的无菌器械必须按规定销毁使其零部件不 再具有使用功能经消毒无害化处理并做好记录 医疗机构不得重复使用无菌器械
生产的监督管理
生产企业只能销售本企业生产的无菌器械 生产企业的销售人员应在销售所在地药品监督
一 加盖本企业印章的医疗器械生产企业许可证、 医疗器械产品注册证的复印件及产品合格证；
二 加盖本企业印章和企业法定代表人印章或签 字的企业法定代表人的委托授权书原件委托授 权书应明确授权范围；
三 销售人员的身份证
医疗机构使用不合格无菌器械不能指明不 合格品生产者的视为使用无产品注册证的产品； 不能指明不合格品供货者的视为从无医疗器械 经营企业许可证的企业购进产品
使用的监督
医疗机构使用无菌器械发生严重不良事件时应在
事件发生后24小时内报告所在地省级药品监督管理部
门和卫生行政部门
医疗机构不得有下列行为：
一 从非法渠道购进无菌器械；
一次性使用精密过滤输液器
一次性使用精密过滤输液器概述一次性使用精密过滤输液器是医疗行业中常见的输液器类型之一。
它通过使用精密过滤器，可以有效去除输液液体中的杂质、细菌等有害物质，确保输液过程的安全性和有效性。
本文将介绍一次性使用精密过滤输液器的特点、应用场景、使用方法以及注意事项。
特点一次性使用精密过滤输液器具有以下特点：1.精密过滤器：该类型的输液器采用精密过滤器，可以有效过滤输液液体中的微小杂质，如悬浮颗粒、细菌等，提高输液液体的纯度。
2.一次性使用：一次性使用精密过滤输液器是为了避免交叉感染而设计的，每次使用后即弃用，确保输液过程的卫生安全。
3.透明材质：该类型输液器采用透明材质制成，可以清晰地观察输液液体的流动状态和液位情况，方便护理人员监测输液过程。
4.方便连接：一次性使用精密过滤输液器通常带有标准的连接器，可以方便地连接输液管路和其他医疗设备，确保输液操作的顺利进行。
应用场景一次性使用精密过滤输液器广泛应用于医疗环境中，特别适用于以下场景：1.手术室：在手术室中，一次性使用精密过滤输液器可以高效过滤输液液体，确保手术过程中注入患者体内的液体纯净无菌，避免术后感染。
2.重症监护室：在重症监护室中，患者的免疫力通常较低，对外界细菌容易感染，一次性使用精密过滤输液器可以有效去除输液液体中的细菌，避免交叉感染的风险。
3.门诊：在门诊环境中，一次性使用精密过滤输液器可以保证输液液体的纯净性，提高治疗效果，减少患者的不适感。
使用方法使用一次性使用精密过滤输液器需要按照以下步骤进行：1.准备工作：在使用前，确认输液器包装完好，无破损和污染。
检查输液器连接部分是否干净。
2.连接输液器：将输液器的连接器与输液袋接口连接，确保连接处紧固，避免液体泄漏。
3.调整滴速：调整滴速器的滴流速度，根据患者需要和医嘱要求进行调整。
4.观察输液状态：观察输液液体的流动状态和液位情况，确保输液过程顺利进行。
5.结束输液：输液结束后，拔掉输液器连接器，将输液器安全处理。
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SMIC/检测（班）医疗器械注册产品标准SMIC/检测（班） 00000-2010一次性使用输液器重力输液式Infusion sets for single use, gravity fee2010-12-10发布 2010-12-13实施上海医疗器械高等专科学校发布SMIC/检测（班） 00000-2010前言本标准是SMIC/检测（班） 00000-2010的初定版。
本标准中华人民共和国国家标准GB 8368-2005（一次性使用输液器重力输液式）。
本标准的附录A,附录B和附录C是规范性附录，附录NA和附录NB是资料性附录。
本标准由上海医疗器械高等专科学校归口。
本标准由检测技术及应用肖婷组起草。
本标准主要起草人:肖婷、徐一君、吴维纶。
本标准主要资料检索人：吴维纶、薛国瑞。
本标准主要实验规划人：薛圣、薛子鸣、温景麟。
本标准首席发布于2010年。
SMIC/检测（班） 00000-2010一次性使用输液器1 范围本标准规定了一次性使用医用输液器的要求，以保证与输液容器和静脉器具相适应。
本标准的第二个目的是为输液器所用材料的性能及质量规范提供指南，并给出了输液器组件的标记。
2 规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。
凡是注日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件，其最新版本适用于本标准。
GB/T8368-2005一次性使用输液器重力输液式(GB/T8368-2005,idt ISO 8536-4:2004((医用输液器具—第4部分:一次性使用输液器，重力输液式)。
GB/注射器、注射针及其他医疗器械6%锥度(鲁尔)圆锥接头第1部分:通用要求(GB/,idtISO594-1:1986)GB/注射器、注射针及其他医疗器械6%锥度(鲁尔)圆锥接头第2部分:锁定锥头(GB/,idtISO594-2:1998)GB/T6682-1992 分析实验室用水规范和试验方法(neqISO3696:1987)GB/医用输液、输血、注射器具检验方法第1部分:化学分析方法GB/医用输液、输血、注射器具检验方法第2部分:生物学试验方法GB15811-2001一次性使用无菌注射针(eqvISO7864:1993)YY0466 医疗器械用于医疗器械标签、标记和提供信息的符号 (YY0466-2003,ISO15223:2000,IDT)ISO14644-1:1999 洁净室和相关控制环境—第1部分:空气洁净度分级3 通用要求输液器组件的命名输液器组件的名称如图1所示，输液器进气器件如图2所示。
注:图1给出了输液器示例，图2示出了分离式进气器件，图1和图2不作为本标准对一次性使用输液器的要求。
无菌的保持输液器应有保护套，保持输液器内部在使用前无菌。
进气器件的瓶塞穿刺器或针应有保护套。
标记3.3.1 输液器符合本标准要求的输液器应以描述文字加本标准编号、字母IS，再加字母G标记:输液器 SMIC00000 - IS-G3.3.2 进气器件符合本标准要求的进气器件应以描述文字加本标准编号，最后加字母AD:进气器件SMIC00000 一A DSMIC/检测（班） 00000-20101—瓶塞穿刺器保护套2—瓶塞穿刺器3—带空气过滤器和塞子的进气口4—液体通道5—滴管6—漏斗7—药液过滤器8—软管9—流量调节器10—注射件11—外圆锥接头12—外圆锥接头保护套a 进气器件可以不带塞子b 药液过滤器可以在其他位置，最好位于病人端药液过滤器的孔径大小一般为15 1-c可以不带注射件图1 输液器示例SMIC/检测（班） 00000-20101—保护套2—瓶塞穿刺器或穿刺针3—管路4—夹子5—带有空气过滤器的进气器件“如能保证同样安全，也可不带夹子或采用其他设计。
图2 典型进气器件示例4材料制造第3章给出的输液器及其进气器件的材料应符合第5章规定的要求。
输液器与输液容器接触的组件，还应符合第6章和第7章规定的要求。
5 物理要求微粒污染应在最小微粒污染条件下制造输液器。
液体通路表面应光滑并洁净，测试输液器内的微粒，是通过冲洗输液器内腔道表面，用适当的方法对微粒进行计数。
按第章试验时，应不超过污染指数。
泄漏按第A .2章试验时，应无气体泄漏现象.连接强度按第A .3章试验时，输液器液体通道各组件间的连接，不包括保护套，应能承受不小于15N 的静拉力，持续15 s.瓶塞穿刺器瓶塞穿刺器的尺寸应符合图3所示。
SMIC/检测（班） 00000-2010单位为毫米图3 瓶塞穿刺器尺寸注:图3中的15mm尺寸为测量基准，穿刺器该处横截面为圆形。
瓶塞穿刺器应能刺透未穿刺过的液体容器的瓶塞，且不宜产生落屑。
进气器件进气器件应符合和的要求。
进气器件应有一个空气过滤器，以防止微生物进人它所插人的容器。
进气器件可以与瓶塞穿刺器连为一体，也可以与之分离。
当进气器件插人硬质输液容器时，进人容器的空气应不进人到流出液中。
空气过滤器的安装应使所有进人硬质容器的空气都通过它。
按第章试验时，相对于从自由进气的容器中流出液体的流量应不降低20%.管路5.6.1 由塑性材料制成的管路应透明或足够透明，当有气泡通过时可以用正常或矫正视力观察到水和空气的分界面。
5.6.2末端至滴斗的管路包(括注射件(如果有)和外圆锥接头〕长度应不小于1500mm,注 :在输液器的总长度不小于1600mm的前提下,末端至滴斗的管路(包括注射件(如果有)和外圆锥接头)长度允许小于1500mm,但应不小于1250mm.药液过滤器输液器应有一药液过滤器，药液过滤器对乳胶粒子的滤除率应不小于80%。
滴斗与滴管滴斗应可以连续观察液滴。
液体应经过一插人滴斗的滴管进人滴斗。
滴管的端部至滴斗出口的距离应不小于40mm，或滴管和药液过滤器间的距离应不小于20mm,滴斗壁与滴管终端的距离不得近于5mm。
在(23士2)0C,流速为(50士10)滴/min的条件下，滴管滴出20滴蒸馏水应为 (1士mL[(1士g]。
滴斗应有助于液体充注过程。
流量调节器流量调节器应能调节液流从零至最大。
流量调节器宜能在一次输液中持续使用而不损伤管路。
流量调节器和管路接触在一起贮存时宜不产生有害反应。
输液流速对于滴管为20滴/mL的输液器，输液器在1m静压头下，10min内输出氯化钠溶液[质量浓度ρ（NaCl）=9g/L]应不少于1000mL；对于滴管为60滴/mL的输液器，输液器在1m静压头下，SMIC/检测（班） 00000-2010 40min内输出氯化钠溶液[质量浓度ρ（NaCl）=9g/L]应不少于1000mL。
注射件如有自密封性注射件时，按第章试验时，水的泄漏量应不超过一滴。
注射件宜位于外圆锥接头附近。
外圆锥接头管路的末端应有一符合GB/或GB/的外圆锥接头。
宜使用符合GB/的(鲁尔)锁定锥头。
保护套输液器终端的保护套应保持瓶塞穿刺器、外圆锥接头和输液器无菌。
保护套宜牢靠，但易于拆除。
6 化学要求环氧乙烷残留量按GB/进行试验时，每套输血器的环氧乙烷残留量应不大于(另见9).7 生物要求无菌单包装内的输液器和(或)进气器件应经过一个确认过的灭菌过程使产品无菌。
8 标志单包装单包装上应至少标有下列信息:1)文字说明内装物，包括“只能重力输液”字样2)使用YY0466中的图形符号，标明输液器无菌3)输液器无热原和无细菌内毒素4)输液器和/或进气器件仅供一次性使用，或同等说明，或使用符合YY0466中的图形符号5)使用说明，包括警示，如关于保护套脱落6)批号，以“批”字或“LOT'，开头，或使用符合YY0466中的图形符号7)失效年月，附以适当文字，或使用符合YY0466中的图形符号8)制造商和/或供应商名称和地址9)滴管滴出20滴或60滴蒸馏水等于(1士mL[即(1士g]的说明10)如配静脉针，应著名标称尺寸搁板或多单元包装搁板包装或多单元包装(如使用)上应至少有下列信息:1)文字说明内装物，包括“只能中立输液”字样2)输液器数量3)使用YY0466中的图形符号，标明输液器无菌4)批号，以“批”字或“LOT”开头，或使用符合YY0466中的图形符号5)失效年月，附以适当文字，或符合YY0466中的图形符号6)制造商和/或供应商的名称和地址7)推荐的贮存条件(如果有)9 包装SMIC/检测（班） 00000-2010输液器和/或进气器件应单件包装，以使其在贮存期内保持无菌。
单包装打开后应留有打开过的迹象。
输液器和/或进气器件的包装和灭菌应使其在备用时无扁瘪或打折。
SMIC/检测（班） 00000-2010附录物理试验A. 1 微粒污染试验，1)A.1.1 原理通过冲洗输液器内腔液体通道表面，收集滤膜上的微粒，并用微粒检测仪进行计数。
A.1.2 试剂和材料A.1.2.1 蒸馏水，用孔径0.2l um的膜过滤。
A.1.2.2 无粉手套。
A.1.2.3 真空滤膜，孔径0. 45um,A.1.3 步骤试验前应用蒸馏水(A.1.2.1)充分清洗过滤装置、滤膜和其他器具。
在层流条件下(符合ISO 14644-1;1999中的N5级)2的净化工作台)，取10支供用状态的输液器，各用500mL蒸馏水(A.1.2.1)冲洗内腔，然后使各洗脱液通过一个真空滤膜，用装有500mL的NaCl 注射液洗瓶冲洗滤膜，样品杯收集的冲洗液，放到仪器样品台上对其进行测量，并按表A. 1所给尺寸分类进行计数。
泄漏试验A.2.1 试验开始前，在试验温度下状态调节整个系统。
A.2.2 将输液器一端堵住，浸人20'C -30℃水中，内部施加高于大气压强50k Pa的气压15s 。
检验输液器空气泄漏。
拉伸强度试验使供试输液器经受15 N的静态轴向拉力15 s，检验输液器是否能承受该拉力。
使用进气器件时流速的测量A.4.1 向一只输液容器内充人(23士2)℃的蒸馏水，盖上瓶塞。
进气器件通过瓶塞插入该容器，然后插人输液器。
关闭流量调节器，调节容器高度，使其在整个试验过程中形成1 m水压头，调节流量调节器至最大，测量输液器中水的流速。
从进气器件上取下过滤器，重复此步骤。
A.4.2 对于进气器件与其瓶塞穿刺器为一体的输液器，按所给步骤进行，但没有插人分离式进气器件的步骤。
注射件试验使注射件水平、不受力放置，向输液器中充人水，避免夹杂气泡，通入高于大气压强50 kPa的压力，用符合GB 15811-2001、外径为0.8 m m的注射针头穿刺注射件的穿刺区域。
插人15s 后拔出注射针并迅速使穿刺处干燥。
观察1 min内有无任何泄漏。
化学实验SMIC/检测（班） 00000-2010SMIC/检测（班） 00000-2010建议性实验瓶塞穿刺器对于与滴斗分离的瓶塞穿刺器，除符合图4规定尺寸要求外，还宜有一个长度不小于20 mm 的把手，以供穿刺时握持;穿刺器的尖部宜光滑无毛刺，否则可认定为不符合第2段的要求。