EN ISO 7886-4-2009 en Sterile hypodermic syringes for single use - Part 4 Syringes with re-use prevention feature《一次性使用无菌皮下注射器 第4部分 具有防止重复使用功能的注射器》.pdf

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1、BS EN ISO7886-4:2009ICS 11.040.25NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterile hypodermicsyringes for single usePart 4: Syringes with re-use preventionfeature (ISO 7886-4:2006)This British Standardwas published underthe authority of theStandards Policy

2、 andStrategy Committee on 30November 2009. BSI 2009ISBN 978 0 580 67783 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 7886-4:2009National forewordThis British Standard is the UK implementation of EN ISO 7886-4:2009.It is identical to ISO 7886-4:2006. It supersedes BS EN ISO 7

3、886-4:2006which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee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 does not purport to include all the necessary provi

4、sionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-4 September 2009 ICS 11.040.25 Supersedes EN ISO 7886-4:2006English Version Sterile hypo

5、dermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) Seringues hypodermiques striles, non rutilisables - Partie 4: Seringues avec dispositif empchant la rutilisation (ISO 7886-4:2006) Sterile Einmalspritzen fr medizinische Zwecke - Teil 4: Spritzen mit V

6、orrichtung zur Verhinderung der Wiederverwendung (ISO 7886-4:2006) This European Standard was approved by CEN on 24 August 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standar

7、d without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 la

8、nguage made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Fin

9、land, France, Germany, 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES

10、KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7886-4:2009: EBS EN ISO 7886-4:2009EN ISO 7886-4:2009 (E) 3 Foreword The text of ISO 7886-4:2006 has b

11、een prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 7886-4:2009. This European Standard shall be given the status of a national stand

12、ard, either by publication of an identical text or by endorsement, at the latest by March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN

13、 and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 7886-4:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requiremen

14、ts of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Bel

15、gium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notic

16、e The text of ISO 7886-4:2006 has been approved by CEN as a EN ISO 7886-4:2009 without any modification. BS EN ISO 7886-4:2009EN ISO 7886-4:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This E

17、uropean Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journa

18、l of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Ess

19、ential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6 1, 7.1, 7.2 7.5

20、 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalates and other toxic substances are not specifically addressed. 7 1, 7.1, 7.2 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalates and other toxic substances a

21、re not specifically addressed. 8 1, 7.1, 7.2 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalates and other toxic substances are not specifically addressed. 9 1, 7.1, 7.2 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the pre

22、sence of phthalates and other toxic substances are not specifically addressed. 10 10.1, 10.3 11 1, 10.1, 10.2, 10.3 11.1 1, 10.1, 10.2, 10.3 11.2 1, 10.1, 10.2,11.3 10.1 12 10.1, 10.2 12.1 10.1, 10.212.2 1, 9, 2, 10.2 BS EN ISO 7886-4:2009EN ISO 7886-4:2009 (E) 5 Table ZA.1 (continued) Clause(s)/sub

23、-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 13.1 1 9.2 1, 2, 3, 10.2, 12.8.2 13.2 1 9.2, 1, 2, 3 , 10.2, 12.8.2 13.3 10.2 14.1 1, 214.2 2, 9.1 15.1 1, 2, 10.1, 10.3 15.2 7.5 10.1 E.R. 7.5 is only partially covered: protection against risks posed

24、 by the presence of phthalates and other toxic substances are not specifically addressed. 15.3 1 - 2 - 8.1 15.4 5 15.5 7.1 Only guidance is given 16.1 7.2, 8.3 16.2 7.2, 8.317 13.1 17.2.1 a) 13.2 13.3 f Except 13.3 (f) (second phrase regarding indication of single use consistent across community) 17

25、.2.1 b) 13.2 17.2.1 c) 13.3 a Except 13.3 (a) (regarding representative in the Community) 17.2.1 d) 13.2 13.3 c 17.2.1 e) 13.2 13.3 d 17.2.1 f) 13.2 13.3 e 17.2.1 g) 13.3 b 17.2.2 a) 13.2 13.3 f Except 13.3 (f) (second phrase regarding indication of single use consistent across community) 17.2.2 b)

26、13.2 17.2.2 c) 13.3 a Except 13.3 (a) (regarding representative in the Community) 17.2.2 d) 13.2 13.3 c 17.2.2 e) 13.2 13.3 d 17.2.2 f) 13.2 13.3 e 17.2.2 g) 13.3 b 17.3 a) 13.2 13.3 f Except 13.3 (f) (second phrase regarding indication of single use consistent across community) BS EN ISO 7886-4:200

27、9EN ISO 7886-4:2009 (E) 6 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 17.3 b) 13.2 17.3 c) 13.3 a Except 13.3 (a) (regarding representative in the Community) 17.3 d) 13.2 13.3 c 17.3 e) 13.2 13.3 d 17.3 f) 13.

28、2 13.3 e 17.3 g) 13.3 b 17.3 h) 13.3 k 17.3 i) 13.3 k 17.3 j) 13.3 i 17.3 k) 13.6 Except 13.6 (h) 2ndphrase NA, feature to prevent re-use is part of the design and except 13.6 (q) (regarding date of issue or latest revision of instructions for use) 17.3 l) 13.3 b 17.4 a) 13.3 b 17.4 b) 13.2 17.4 c)

29、13.2 13.3 d 17.4 d) 13.2 13.3 e 17.4 e) 13.2 13.3 c 17.4 f) 13.3 a Except 13.3 (a) (regarding representative in the Community) 17.4 g) 13.3 i 17.4 h) 13.3 b NOTE 6 a Requirement on clinical evaluation not covered by this standard WARNING Other requirements and other EU Directives may be applicable t

30、o the product(s) falling within the scope of this standard. BS EN ISO 7886-4:2009ISO 7886-4:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Nomenclature 2 5 Types of syringe . 2 6 Cleanliness 2 7 Lim

31、its for acidity or alkalinity 2 8 Limits for extractable metals . 2 9 Lubricant 4 10 Tolerance on graduated capacity 4 11 Graduated scale 4 12 Barrel 4 13 Piston/plunger assembly . 4 14 Syringe nozzle/needle 5 15 Performance 5 16 Packaging 6 17 Labelling 6 Annex A (normative) Method for preparation

32、of extracts 9 Annex B (normative) Test method for testing re-use prevention feature for RUP syringes 10 Annex C (informative) Environmental aspects 11 Bibliography . 12 BS EN ISO 7886-4:2009ISO 7886-4:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardiza

33、tion) 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

34、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 Standard

35、s 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 Interna

36、tional 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 7886-4 wa

37、s prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters, Subcommittee SC 1, Syringes, needles and intravascular catheters for single use. ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes fo

38、r single use: Part 1: Syringes for manual use Part 2: Syringes for use with power-driven syringe pumps Part 3: Auto-disable syringes for fixed-dose immunization Part 4: Syringes with re-use prevention feature BS EN ISO 7886-4:2009ISO 7886-4:2006(E) ISO 2006 All rights reserved vIntroduction The prep

39、aration of this part of ISO 7886 was recognized as a high priority requirement to prevent the re-use of syringes in the developing and transitional countries. Re-use of injection equipment in the absence of sterilization has increasingly led to transmission of blood-borne pathogens. See Reference 1

40、in the Bibliography. The World Health Organisation had produced a specification for syringes that are rendered inactive after use (commonly referred to as “auto-disable” syringes) for fixed dose immunization and syringes with re-use prevention features for general purpose. Both the WHO and ISO agree

41、d that additional parts of ISO 7886 would be required to cover syringes with re-use prevention features, whilst leaving in place ISO 7886-1 and ISO 7886-2 without modification, as a large number of devices in common use would not be intended to comply with the re-use prevention properties suggested.

42、 This part of ISO 7886 is intended to cover syringes that are rendered inoperable after delivery of the intended dose. These syringes are not covered by ISO 7886-1 and ISO 7886-3. ISO 7886-2 covers syringes used with power-driven pumps. Given the diversity of clinical applications, the most appropri

43、ate re-use prevention feature offering the highest level of re-use prevention is to be considered for each specific intended use. It is recognized that syringes designed to reduce the risk of needlestick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention prope

44、rties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886. BS EN ISO 7886-4:2009BS EN ISO 7886-4:2009INTERNATIONAL STANDARD ISO 7886-4:2006(E) ISO 2006 All rights reserved 1Sterile hypodermic syringes for single use Part 4: Syring

45、es with re-use prevention feature 1 Scope This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such t

46、hat the syringe can be rendered unusable after use. This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids

47、. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this part of ISO 7886. NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention properties, but

48、 it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated r

49、eferences, the latest edition of the referenced document (including any amendments) applies. ISO 780, Packaging Pictorial marking for handling of goods ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 7000, Graphical symbols for use on equipment Index and synopsis ISO 7864:1993, Sterile hypodermic needles for single use ISO 7886-1:1993, Sterile hypodermic syringes for single use Part 1: Syringes for manual use ISO 8537:1991, Sterile single-use syringes, with