DIN EN ISO 7886-3-2010 Sterile hypodermic syringes for single use - Part 3 Auto-disable syringes for fixed-dose immunization (ISO 7886-3 2005) German version EN ISO 7886-3 2009《一次性.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!$t“1568161ww

2、w.din.deDDIN EN ISO 7886-3Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization(ISO 7886-3:2005)English version of DIN EN ISO 7886-3:2010-01Sterile Einmalspritzen fr medizinische Zwecke Teil 3: Selbstblockierende Spritzen fr die Injektion mit fixer Impf

3、stoffdosis(ISO 7886-3:2005)Englische Fassung DIN EN ISO 7886-3:2010-01SupersedesDIN EN ISO 7886-3:2005-06www.beuth.deDocument comprises 21 pagesDIN EN ISO 7886-3:2010-01 2 Start of validity This standard takes effect on 1 January 2010. National foreword This standard has been prepared by Technical C

4、ommittee ISO/TC 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),

5、 Working Committee 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 3696 DIN ISO 3696 ISO 7864 DIN EN ISO 7864 ISO 7886-1 DIN EN ISO 7886-1 ISO 8537 DIN EN ISO 8537 ISO 9626 DIN EN ISO 9626

6、Amendments This standard differs from DIN EN ISO 7886-3:2005-06 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 EU Directive 2007/47/EC of the

7、 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 placing on the market of biocidal p

8、roducts. Previous editions DIN EN ISO 7886-3: 2005-06 National Annex NA (informative) Bibliography DIN EN ISO 7864, Sterile hypodermic 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, wi

9、th or without needle, for insulin DIN EN ISO 9626, Stainless steel needle tubing for manufacture of medical devices DIN ISO 3696, Water for analytical laboratory use Specification and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-3 September 2009 ICS 11.040.25 Supersedes

10、 EN ISO 7886-3:2005English Version Sterile 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 Einm

11、alspritzen fr medizinische Zwecke - 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 f

12、or giving this European Standard the 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 offic

13、ial versions (English, French, German). 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,

14、 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 United Kingdom. EUROPEAN COMMITTE

15、E FOR STANDARDIZATION COMIT EUROPEN 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: EContents Page Foreword

16、.3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Nomenclature.6 5 Cleanliness.7 6 Limits for acidity or alkalinity.7 7 Limits for extractable metals7 8 Lubricant 7 9 Tolerance on nominal capacity7 10 Graduated scale.7 11 Barrel 8 12 Piston/plunger assembly8 13 Needle.8

17、 14 Performance.9 15 Packaging.10 16 Labelling.10 Annex A (normative) Method for preparation of extracts.13 Annex B (informative) Test method for forces required to operate plunger 14 Annex C (normative) Test method for testing auto-disable feature 16 Bibliography17 Annex ZA (informative) Relationsh

18、ip between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .18 2 DIN EN ISO 7886-3:2010-01 EN ISO 7886-3:2009 (E) Foreword 3 The text of ISO 7886-3:2005 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal prod

19、ucts 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 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2

20、010, 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 and/or CENELEC shall not be held responsible for identifying any or all such patent rights

21、. 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 supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is

22、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, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,

23、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 7886-3:2005 has been approved by CEN as a EN ISO 7886-3:2009 without any

24、modification. EN ISO 7886-3:2009 (E) DIN EN ISO 7886-3:2010-01 Introduction ISO 7886 was 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

25、use with power-driven pumps. The preparation of this third part of ISO 7886 was recognized 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 increasi

26、ngly led to transmission of blood-borne pathogens. The World Health Organization had produced 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 cove

27、r “auto-disable” syringes, whilst leaving in place ISO 7886 Parts 1 and 2 without modification, 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 ar

28、e rendered inoperable after delivery of the intended dose. These syringes are not covered 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 regar

29、d to their auto-disable properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886. 4 DIN EN ISO 7886-3:2010-01 EN ISO 7886-3:2009 (E) 1 Scope This part of ISO 7886 specifies the properties and performance of sterile single-us

30、e 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 dose of vaccine, the syringe is automatically rendered unusable. This part of IS

31、O 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), syringes made of glass (specified in ISO 595), syringes for use with power-driven syr

32、inge 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 is being prepared to cover syringes with reuse prevention feature. 2 Normativ

33、e 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 document (including any amendments) applies. ISO 3696:1987, Water for analytical

34、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 single-use syringes, with or without needle, for insulin ISO 9626, Stainless steel

35、 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 7886-3:2009 (E) DIN EN ISO 7886-3:2010-01 3 Terms and definitions For the pur

36、poses 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 activates upon administration of the intended fixed dose to prevent subsequent re-use of the syr

37、inge 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-disable feature 6 nominal capacity line 7 piston 8 fiducial line 9 seal(s) 10 finger grips 11 pl

38、unger 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 6 DIN EN ISO 7886-3:2010-01 EN ISO 7886-3:2009 (E) 5 Cleanliness Clause 5 of IS

39、O 7886-1:1993 shall apply. 6 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 within one unit of pH of that of the control fluid. 7 Limits for extractable metals

40、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 greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmiu

41、m content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0,1 mg/l. 8 Lubricant Clause 8 of ISO 7886-1:1993 and 11.4 of ISO 7864:1993 shall apply. 9 Tolerance on nominal capacity The volume of water at (20 5) C or, for tropical countries (27 5) C expe

42、lled from the syringe when the fiducial line of the piston traverses the full scale (i.e. the intended fixed dose) shall be within the tolerances on the nominal capacity as specified in Table 1. Table 1 Nominal capacity and dead space Nominal capacity Tolerance on nominal capacity Maximum dead space

43、 for integrated and non-integrated needle ml % ml 0,05 u V u 0,2 20 % 0,025 0,2 V u 2 5 % 0,07 10 Graduated scale 10.1 Scale The scale shall have only two markings, the zero line and the nominal capacity line (i.e. the total graduated capacity line). These lines shall be of uniform thickness. They s

44、hall lie in planes at right angles to the axis of the barrel. 10.2 Position of scale 10.4 of ISO 7886-1:1993 shall apply. 7 EN ISO 7886-3:2009 (E) DIN EN ISO 7886-3:2010-01 11 Barrel 11.1 Dimensions The length of the barrel and the design of the auto-disable feature shall be such that the syringe ha

45、s a maximum usable capacity of at least 10 % more than the nominal capacity and a recommended maximum capacity of 20 % more than the nominal capacity. 11.2 Finger grips 11.2 of ISO 7886-1:1993 shall apply. 12 Piston/plunger assembly 12.1 Design The design of the plunger and push-button of the syring

46、e shall be such that, when the barrel is held in one hand, the plunger can be depressed by the thumb of that hand. The piston shall not become detached from the plunger when tested in accordance with Annex B of ISO 8537:1991 for a syringe with integrated needle or in accordance with Annex B of ISO 7

47、886-1:1993 for a syringe without needle. The plunger should be of a length adequate to allow the piston properly to deliver the designated fixed dose. It should not be possible to defeat the auto-disable feature by removing and re-inserting the plunger. The projection of the plunger and the configur

48、ation of the push-button should be such as to allow the plunger to be operated without difficulty. When the fiducial line of the piston coincides with the zero graduation line, the preferred minimum length of the plunger from the surface of the finger grips nearer to the push-button shall be 8 mm. 1

49、2.2 Fit of the piston in the barrel 12.2 of ISO 7886-1:1993 shall apply. NOTE Annex B gives a suggested test method and performance criteria for the forces required to move the plunger. 12.3 Fiducial line 12.3 of ISO 7886-1:1993 shall apply. 13 Needle 13.1 Integrated needle Syringes with integrated needle shall have a minimum needle union force applied as push or pull in the direction of the needle axis in accordance with ISO 7864:1993. Needle tubing shall be in accordance with ISO 9626. 13.2 Non-integrated needle If a non-integrated need