BS EN ISO 7886-3-2009 Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization《一次性使用无菌皮下注射器 固定剂量免疫接种用自动报废注射器》.pdf

1、BS EN ISO7886-3:2009ICS 11.040.25NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterile hypodermicsyringes for single usePart 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)This British Standardwas published underthe authority of theStand

2、ards Policy andStrategy Committee on 30November 2009. BSI 2009ISBN 978 0 580 67785 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 7886-3:2009National forewordThis British Standard is the UK implementation of EN ISO 7886-3:2009.It is identical to ISO 7886-3:2005. It supersedes

3、BS EN ISO 7886-3:2005which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee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 nece

4、ssary provisionsof 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 7886-3 September 2009 ICS 11.040.25 Supersedes EN ISO 7886-3:2005English Version S

5、terile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) Seringues hypodermiques striles, non rutilisables - Partie 3: Seringues autobloquantes pour vaccination dose fixe (ISO 7886-3:2005) Sterile Einmalspritzen fr medizinische Zwecke -

6、Teil 3: Selbstblockierende Spritzen fr die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005) 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

7、 status of a national standard 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, Germa

8、n). A version in any other language 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 Re

9、public, 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN

10、DE NORMALISATION EUROPISCHES 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 7886-3:2009: EBS EN ISO 7886-3:2009EN ISO 7886-3:2009 (E) 3 Foreword The

11、text of ISO 7886-3:2005 has been 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 7886-3:2009. This European Standard shall be given t

12、he status of a national standard, 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

13、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 7886-3:2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and

14、supports essential requirements 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 Eu

15、ropean Standard: Austria, Belgium, 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 Unit

16、ed Kingdom. Endorsement notice The text of ISO 7886-3:2005 has been approved by CEN as a EN ISO 7886-3:2009 without any modification. BS EN ISO 7886-3:2009EN ISO 7886-3:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/

17、EEC on medical devices This European 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

18、 cited in the Official Journal 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 conformi

19、ty with the corresponding Essential 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 re

20、marks/Notes 5 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. 6 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalat

21、es 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 are not specifically addressed. 8 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered: protecti

22、on against risks posed by the presence of phthalates and other toxic substances are not specifically addressed. 9 10.1, 10.3 10 1, 10.1, 10.2, 10.3 11.1 1, 10.1, 10.211.2 10.2 12.1 1, 2, 3, 10.2, 12.8.2 12.2 1, 2, 3, 12.8.1, 12.8.2 12.3 10.2 13.1 1, 2BS EN ISO 7886-3:2009EN ISO 7886-3:2009 (E) 5 Tab

23、le ZA.1 (continued) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC 13.2 1, 2, 9.1 14.1 1, 2, 10.1, 10.3 14.2 1, 2, 7.5, 7.6 14.3 1, 2, 3, 12.8.2, 8.1 14.4 5 15.1 3, 7.2, 8.3, 8,7 15.2 7.2, 8.3, 8,7 16 13.1, 13.2, 13.3, 13.4, 13.5, 13.6 Except 13.3 (f) (second

24、phrase regarding indication of single use consistent across community), except 13.3 (a) (regarding representative in the Community), except 13.6 (h) 2ndphrase (information on known characteristics and technical factors known to manufacturer that could pose a risk if reused) and 13.6 (q) (regarding d

25、ate of issue or latest revision of instructions for use) NOTE 6 a Requirement on clinical evaluation not covered by this standard WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 7886-3:2009ISO 7886-3:2005(E)

26、iii ISO 2005 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 Cleanliness 3 6 Limits for acidity or alkalinity 3 7 Limits for extractable metals . 3 8 Lubricant 3 9 Tolerance on nominal capacity . 3 10

27、Graduated scale 3 11 Barrel 4 12 Piston/plunger assembly 4 13 Needle. 4 14 Performance 5 15 Packaging 6 16 Labelling. 6 Annex A (normative) Method for preparation of extracts 9 Annex B (informative) Test method for forces required to operate plunger 10 Annex C (normative) Test method for testing aut

28、o-disable feature 12 Bibliography . 13 BS EN ISO 7886-3:2009ISO 7886-3:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is

29、 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

30、 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 pr

31、epare 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

32、 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 7886-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters, Subcomm

33、ittee SC 1, Syringes, needles and intravascular catheters for single use. ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes for single use: Part 1: Syringes for manual use Part 2: Syringes for use with power-driven syringe pumps Part 3: Auto-disable syring

34、es for fixed-dose immunization Part 4: Syringes with reuse prevention feature For the purposes of this part of ISO 7886, the CEN annex regarding fulfilment of European Council Directives has been removed. BS EN ISO 7886-3:2009ISO 7886-3:2005(E) v ISO 2005 All rights reserved vIntroduction ISO 7886 w

35、as first published in 1984. It was subsequently decided to divide it into two parts, ISO 7886-1 retaining essentially the scope of ISO 7886:1984, and ISO 7886-2 being applicable to sterile, single-use syringes for use with power-driven pumps. The preparation of this third part of ISO 7886 was recogn

36、ized as a high priority requirement to prevent the re-use of fixed dose immunization 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. The World Health Organization had p

37、roduced a specification for syringes that are rendered inactive after use (commonly referred to as “auto-disable” syringes). Both the WHO and ISO agreed that an additional part of ISO 7886 would be required to cover “auto-disable” syringes, whilst leaving in place ISO 7886 Parts 1 and 2 without modi

38、fication, as a large number of devices in common use would not be intended to comply with the auto-disable properties suggested. This part of ISO 7886 is intended to cover “fixed dose” immunization syringes that are rendered inoperable after delivery of the intended dose. These syringes are not cove

39、red by Parts 1 and 2 of ISO 7886. It is recognized that syringes designed to reduce the risk of needlestick injuries, in addition to preventing sharps injuries, may also comply with this part of ISO 7886 with regard to their auto-disable properties, but it is stressed that anti-needlestick propertie

40、s of syringes are not in themselves addressed in this part of ISO 7886. BS EN ISO 7886-3:2009BS EN ISO 7886-3:2009INTERNATIONAL STANDARD ISO 7886-3:2005(E) ISO 2005 All rights reserved 1Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization 1 Scope This

41、part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed do

42、se of vaccine, the syringe is automatically rendered unusable. This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer. This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringe

43、s made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines. NOTE A fourth part of ISO 7886

44、 is being prepared to cover syringes with reuse prevention feature. 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 references, the latest edition of the referenced doc

45、ument (including any amendments) applies. ISO 3696:1987, Water for analytical laboratory use Specification and test methods 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 sing

46、le-use syringes, with or without needle, for insulin ISO 9626, Stainless steel needle tubing for the manufacture of medical devices ASTM D999-01, Standard methods for vibration testing of shipping containers ASTM D5276-98, Standard test method for drop test of loaded containers by free fall BS EN IS

47、O 7886-3:2009ISO 7886-3:2005(E) 2 ISO 2005 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 7886-1:1993 (except 3.2) and ISO 8537:1991 (except 3.1) and the following apply. 3.1 auto-disable syringe feature feature that automatically

48、 activates upon administration of the intended fixed dose to prevent subsequent re-use of the syringe and the needle 4 Nomenclature The nomenclature for components of auto-disable syringes for fixed dose is shown in Figure 1. Key 1 needle cap or end cap (if used) 2 needle 3 zero line 4 barrel 5 auto

49、-disable feature 6 nominal capacity line 7 piston 8 fiducial line 9 seal(s) 10 finger grips 11 plunger 12 push-button 13 protective end cap (if used) NOTE The drawing is intended to be illustrative of components of an auto-disable syringe only. Figure 1 Schematic representation of auto-disable syringe for fixed dose BS EN ISO 7886-3:2009ISO 7886-3:2005(E) ISO 2005 All rights reserved 35 Cleanliness Clause 5 of ISO 7886-1:1993 shall apply. 6 Limits for acidity or alkalinity When determined with a laboratory pH meter and using a general