DIN EN ISO 7886-4-2010 Sterile hypodermic syringes for single use - Part 4 Syringes with re-use prevention feature (ISO 7886-4 2006) German version EN ISO 7886-4 2009《一次性无菌皮下注射器 第4.pdf

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1、January 2010DEUTSCHE NORM English price group 12No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.25!$ta“1568162w

2、ww.din.deDDIN EN ISO 7886-4Sterile hypodermic syringes for single use Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)English version of DIN EN ISO 7886-4:2010-01Sterile Einmalspritzen fr medizinische Zwecke Teil 4: Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung(ISO

3、7886-4:2006)Englische Fassung DIN EN ISO 7886-4:2010-01SupersedesDIN EN ISO 7886-4:2006-12www.beuth.deDocument comprises 21 pagesDIN EN ISO 7886-4:2010-01 2 Start of validity This standard takes effect on 1 January 2010. National foreword This standard has been prepared by Technical Committee ISO/TC

4、 84 “Devices for administration of medicinal products and intravascular catheters” in collaboration with Technical Committee CEN/SS S03 “Syringes” (Secretariat: CMC). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Commit

5、tee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in clause 2 of this document are as follows: ISO 780 DIN EN ISO 780 ISO 3696 DIN ISO 3696 ISO 7000 DIN ISO 7000 ISO 7864 DIN EN ISO 7864 ISO 7886-1 DIN EN ISO 7886-1 ISO 8537 DIN EN ISO

6、8537 ISO 9626 DIN EN ISO 9626 Amendments This standard differs from DIN EN ISO 7886-4:2006-12 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of

7、EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placi

8、ng on the market of biocidal products. Previous editions DIN EN ISO 7886-4: 2005-06 National Annex NA (informative) Bibliography DIN EN ISO 780, Packaging Pictorial marking for the handling of goods DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 7864, Sterile hypo

9、dermic needles for single use DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual use DIN EN ISO 8537, Sterile single-use syringes, with or without needle, for insulin DIN EN ISO 9626, Stainless steel needle tubing for manufacture of medical devices DIN ISO 3696

10、, Water for analytical laboratory use Specification and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-4 September 2009 ICS 11.040.25 Supersedes EN ISO 7886-4:2006English Version Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature

11、(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 Vorrichtung zur Verhinderung der Wiederverwendung (ISO 7886-4:2006) This European

12、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 standard without any alteration. Up-to-date lists and bibliographical references concern

13、ing 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 language made by translation under the responsibility of a CEN member into its own

14、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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani

15、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN

16、All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7886-4:2009: EContents 2 DIN EN ISO 7886-4:2010-01 EN ISO 7886-4:2009 (E) Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Nomenclature.6

17、5 Types of syringe6 6 Cleanliness.6 7 Limits for acidity or alkalinity.6 8 Limits for extractable metals6 9 Lubricant 8 10 Tolerance on graduated capacity 8 11 Graduated scale.8 12 Barrel 8 13 Piston/plunger assembly8 14 Syringe nozzle/needle.9 15 Performance.9 16 Packaging.10 17 Labelling.10 Annex

18、A (normative) Method for preparation of extracts.13 Annex B (normative) Test method for testing re-use prevention feature for RUP syringes.14 Annex C (informative) Environmental aspects 15 Bibliography16 Annex ZA (informative) Relationship between this European Standard and the Essential Requirement

19、s of EU Directive 93/42/EEC on medical devices .17 Foreword The text of ISO 7886-4:2006 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 ove

20、r as EN ISO 7886-4:2009. 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 March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the po

21、ssibility 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 7886-4:2006. This document has been prepared under a mandate given to CEN by the E

22、uropean Commission and the European Free Trade Association, and 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 organiz

23、ations 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, Malta, Netherlands, Norway, Poland, Portugal, Roma

24、nia, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 7886-4:2006 has been approved by CEN as a EN ISO 7886-4:2009 without any modification. 3 EN ISO 7886-4:2009 (E) DIN EN ISO 7886-4:2010-01 Introduction The preparation of this part of ISO 78

25、86 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 in the Bibliography. The World

26、 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 agreed that additional parts of ISO

27、 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. This part of ISO 7886 is inte

28、nded 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 appropriate re-use prevention feature

29、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 properties, but it is stressed that

30、 anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886. 4 DIN EN ISO 7886-4:2010-01 EN ISO 7886-4:2009 (E) 1 Scope This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and

31、 intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that 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 immun

32、ization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. 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 ne

33、edlestick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention properties, but 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 ind

34、ispensable 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 780, Packaging Pictorial marking for handling of goods ISO 3696:1987, Water for analyti

35、cal 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

36、 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 5 EN ISO 7886-

37、4:2009 (E) DIN EN ISO 7886-4:2010-01 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 7886-1, ISO 8537 and the following apply. 3.1 re-use prevention feature feature that either automatically activates upon or during administration of the intended dos

38、e or is activated by the user to prevent subsequent re-use of the syringe 4 Nomenclature The nomenclature for components of syringes with re-use prevention feature is shown in Figure 1. 5 Types of syringe 5.1 General Syringe types shall be categorized in accordance with 5.2 and 5.3. Given the divers

39、ity of clinical applications, the most appropriate re-use prevention feature offering the highest level of re-use prevention should be considered for each specific intended use. 5.2 Re-use prevention feature The re-use prevention feature shall be categorized as follows; Type 1: operates automaticall

40、y during or upon completion of intended single use; Type 2: requires elective activation upon completion of intended single use. 5.3 Intended use/application The intended use/application shall be categorized as follows; Type A: single aspiration and injection; Type B: multiple plunger aspirations pr

41、ior to the final intended single use. 6 Cleanliness The requirements of Clause 5 of ISO 7886-1:1993 apply. 7 Limits for acidity or alkalinity When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with Annex A shall be with

42、in one unit of pH of that of the control fluid. 8 Limits for extractable metals When tested by a recognized microanalytical method, for example by an atomic absorption method, an extract prepared in accordance with Annex A shall, when corrected for the metals content of the control fluid, contain no

43、t greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0,1 mg/l. 6 DIN EN ISO 7886-4:2010-01 EN ISO 7886-4:2009 (E) Key 1 needle cap/protective end cap (if used) 2 nee

44、dle 3 zero line 4 barrel 5 re-use prevention 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 1 The syringe can have graduated scale lines in accordance with ISO 7886-1. NOTE 2 This illustration can be c

45、onsidered as reference for nomenclature of components. The configuration and design can vary with the design of syringe. NOTE 3 The drawing is intended to be illustrative of components of a syringe with a re-use prevention feature. Figure 1 Schematic representation of a syringe with re-use preventio

46、n feature 7 EN ISO 7886-4:2009 (E) DIN EN ISO 7886-4:2010-01 9 Lubricant The requirements of Clause 8 of ISO 7886-1:1993 and 11.4 of ISO 7864:1993 apply. 10 Tolerance on graduated capacity The tolerances on the graduated capacity shall be as given in ISO 7886-1:1993, Table 1 or, for insulin syringes

47、, shall be as given in reference ISO 8537:1991, Table 1. 11 Graduated scale 11.1 Scale Graduated scales shall comply with 10.1 of ISO 7886-1:1993 or 9.1 of ISO 8537:1991. 11.2 Numbering of scale The requirements of 10.2 of ISO 7886-1:1993 or 9.2 of ISO 8537:1991 apply as appropriate. 11.3 Position o

48、f scale The requirements of 10.4 of ISO 7886-1:1993 apply. 11.4 Overall length of scale to nominal capacity line The requirements of 10.3 of ISO 7886-1:1993 or 9.3 of ISO 8537:1991 apply except for fixed dose scales. 12 Barrel 12.1 Dimensions The length of the barrel and the design of the re-use pre

49、vention feature shall be such that the syringe has a recommended maximum usable capacity of at least 5 % more than the nominal capacity and a recommended maximum capacity of 20 % more that the nominal capacity. 12.2 Finger grips The requirements of 11.2 of ISO 7886-1:1993 apply. 13 Piston/plunger assembly 13.1 Design The design of the plunger and push-button of the syringe shall be such that, when the barrel is held in one hand, the plunger can be depressed by the thumb of that hand. When a syringe with integrated needle is tested in a