EN ISO 8537-2008 7179 Sterile single-use syringes with or without needle for insulin《胰岛素用有或无针头一次性无菌注射器》.pdf

1、BS EN ISO8537:2008ICS 11.040.25NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterile single-usesyringes, with orwithout needle, forinsulin (ISO 8537:2007)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIThis Br

2、itish Standard was published under theauthority of the StandardsPolicy and StrategyCommittee on 2008 BSI 2008ISBN 978 0 580 56065 1Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 8537:2008National forewordThis British Standard is the UK implementation of EN ISO 8537:2008. Itis i

3、dentical to ISO 8537:2007. It supersedes BS EN ISO 8537:1995 whichis withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication d

4、oes not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.30 SeptemberLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Co

5、py, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 8537July 2008ICS 11.040.25 Supersedes EN ISO 8537:1994 English VersionSterile single-use syringes, with or without needle, for insulin(ISO 8537:2007)Seringues insuline, striles, non rutilisables, avec ousans aiguille (ISO 8537:2007)Ste

6、rile Insulin-Einmalspritzen mit oder ohne Kanle (ISO8537:2007)This European Standard was approved by CEN on 15 June 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without

7、 any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made

8、 by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, G

9、ermany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGM

10、anagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8537:2008: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8

11、537:2008EN ISO 8537:2008 (E) 3 Foreword The text of ISO 8537:2007 has been prepared by Technical Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8537:2008 by Technical Committee CEN/TC 205 “Non-active

12、medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2009, and conflicting national standards shall be withdrawn at the latest by Janua

13、ry 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8537:1994. According to the CEN/CENELEC Inter

14、nal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal

15、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8537:2007 has been approved by CEN as a EN ISO 8537:2008 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/0

16、1/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008ISO 8537:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Types of syringe . 3 5 Freedom from extraneous matter . 3 6 Limits for extraneous m

17、atter . 3 7 Lubrication of syringes and needles 4 8 Range of sizes. 4 9 Graduated scale 4 10 Barrel 5 11 Piston/plunger assembly . 5 12 Nozzle. 6 13 Needle tubing and needles 6 14 Performance of assembled syringe 6 15 Packaging 7 16 Marking 8 Annex A (normative) Fluid for determination of acidity/al

18、kalinity and extractable metals 11 Annex B (normative) Test method for air leakage past syringe piston during aspiration . 12 Annex C (normative) Test method for force required to operate plunger 14 Annex D (normative) Properties of needles and needle tubing 15 Annex E (normative) Test method for de

19、termination of dead space 17 Annex F (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression. 18 Annex G (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during aspiration. 20 Annex H (informative)

20、Preparation of extract for test for pyrogenicity and toxicity . 21 Annex I (informative) Symbol for “do not re-use” 22 Bibliography . 23 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008ISO 8537:2007(E) iv ISO 2007 All rights reser

21、vedForeword ISO (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

22、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 matt

23、ers 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 circul

24、ated 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 responsib

25、le for identifying any or all such patent rights. ISO 8537 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters. This second edition cancels and replaces the first edition (ISO 8537:1991) and its Amendment 1 (ISO 8537:1991/Amd.1:

26、2000), which have been technically revised. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008ISO 8537:2007(E) ISO 2007 All rights reserved vIntroduction This International Standard deals with products primarily intended for use wit

27、h humans and provides performance requirements, but permits some variations of design and of the methods of packaging and sterilization by individual manufacturers. Materials to be used for the construction and lubrication of sterile syringes and needles for single use are not specified as their sel

28、ection will depend to some extent upon the design, process of manufacture and sterilization method employed by individual manufacturers. Syringes and needles should be manufactured and sterilized in accordance with recognized national or international codes of good manufacturing practice for medical

29、 devices, and should be free from defects affecting appearance, safety and serviceability for their intended use. Certain grades of polypropylene, polystyrene and styrene/acryIonitrile copolymer have been extensively used for the barrels of sterile syringes for single use. A high quality natural rub

30、ber composition is frequently used for the piston, although other materials such as silicone rubber are also used, the surface of the piston being lubricated with polydimethylsiloxane. For 2 ml syringes, high density polyethylene is frequently used for the seal of the two-component design of syringe

31、 in combination with a polypropylene barrel containing a fatty acid amide slip additive. When selecting materials, make the following considerations: Clarity of barrel: Materials used in the construction of the wall of the syringe barrel should be of sufficient clarity to enable dosages to be read w

32、ithout difficulty and for air bubbles to be seen. Compatibility with insulin preparations: The materials of syringes and needles (including lubricant) and packaging should not, in their final form after sterilization and under conditions of normal use, detrimentally affect the efficacy, safety and a

33、cceptability of insulin preparations: neither should the construction materials themselves be affected physically or chemically by insulin preparations. Biocompatibility: The materials should not cause the syringes and needles to yield, under conditions of normal use, significant amounts of toxic su

34、bstances and should permit them to satisfy the appropriate national requirements or regulations for freedom from pyrogenic materials and abnormal toxicity. For testing these properties, an extract as specified in Annex H may be used. It is strongly recommended that regulatory authorities, pharmacopo

35、eia and relevant trade associations should recognize the need for further testing, especially for incompatibility between the insulins and syringes when they are in contact for prolonged periods. In some countries national regulations are legally binding and the requirements may take precedence over

36、 this International Standard. This International Standard describes syringes with or without needles for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). It is recommended that syringes graduated for only one strength of insulin be used in each country to avoid accidents.

37、For those countries using more than one strength of insulin, the importance of having individual syringes appropriately graduated for only one strength of insulin as specified in this International Standard is emphasized. Serious problems may result if a syringe is used with a strength of insulin fo

38、r which it is not designed. If the syringe is used for mixing different types of insulin, it is strongly recommended that the procedure is performed in the same order each time. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008Lice

39、nsed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008INTERNATIONAL STANDARD ISO 8537:2007(E) ISO 2007 All rights reserved 1Sterile single-use syringes, with or without needle, for insulin 1 Scope This International Standard specifies requi

40、rements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). Sterile syringes specified in

41、 this International Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition

42、 cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 7864:1993, Sterile hypodermic

43、needles for single use ISO 9626, Stainless steel needle tubing for manufacture of medical devices 3 Terms and definitions For the purposes of this document the following terms and definitions apply. The nomenclature of some components of syringes for single use is given in Figure 1. 3.1 graduated ca

44、pacity volume of water at 20 C 3 C or 27 C 3 C expelled from the syringe when the fiducial line on the piston traverses a given scale interval or intervals 3.2 needle cap protective end cap intended to maintain the sterility of the needle tube and to protect physically the needle tube and needle hub

45、, if present 3.3 needle sheath cover intended to provide physical protection to the needle tube 3.4 protective end caps covers intended to enclose the projecting portion of the plunger and push-button at one end and the nozzle and/or the needle at the other end Licensed Copy: Wang Bin, ISO/EXCHANGE

46、CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008ISO 8537:2007(E) 2 ISO 2007 All rights reservedKey 1 needle cap 9 push-button 2 protective end cap 10 protective end cap 3 nozzle lumen 11 finger grips 4 nozzle 12 fiducial line 5 barrel 13 nominal capacity 6 piston 14 g

47、raduation lines 7 seals 15 zero line 8 plunger NOTE This figure is intended to be illustrative of components of a syringe only. It does not show a detachable needle or a permanently attached needle tube, and does not form part of the specification. The piston/plunger assembly might or might not be o

48、f integral construction and might incorporate more than one seal. Figure 1 Schematic representation of insulin syringe for single use Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/01/2009 02:56, Uncontrolled Copy, (c) BSIBS EN ISO 8537:2008ISO 8537:2007(E) ISO 2007 All rights reserved 34

49、 Types of syringe The types of syringe shall be designated as follows in relation to their packaging and combinations with needles: Type 1: Syringe having a 6 % (Luer) male conical fitting, supplied without a needle and packaged in a unit container. Type 2: Syringe having a 6 % (Luer) male conical fitting, and supplied without a needle and fitted with protective end caps. Type 3: Syringe having a 6 % (Luer) male conical fitting, and supplied with a detached or detachable needle and packaged in a unit container. Type 4: Syringe having