BS ISO 11040-5-2012 Prefilled syringes Plunger stoppers for injectables《预灌装注射器 针剂栓塞》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 11040-5:2012Prefilled syringesPart 5: Plunger stoppers for injectablesBS ISO 11040-5:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation o

2、f ISO 11040-5:2012.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users a

3、re responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 78214 5ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theSt

4、andards Policy and Strategy Committee on 29 February 2012.Amendments issued since publicationDate Text affectedBS ISO 11040-5:2012 ISO 2012g51g85g72g191g79g79g72g71g3g86g92g85g76g81g74g72g86g3g178Part 5:g3g51g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g73g82g85g3g76g81g77g72g70g87g68g69g79g72g86Se

5、ringues prremplies Partie 5: Bouchons-pistons pour produits injectablesINTERNATIONAL STANDARDISO11040-5Third edition2012-01-15Reference numberISO 11040-5:2012(E)BS ISO 11040-5:2012g3g44g54g50g3g20g20g19g23g19g16g24g29g21g19g20g21g11g40g12iig3 ISO 2012 All rights reservedg38g50g51g60g53g44g42g43g55g3

6、g51g53g50g55g40g38g55g40g39g3g39g50g38g56g48g40g49g55 ISO 2012g36g79g79g3g85g76g74g75g87g86g3g85g72g86g72g85g89g72g71g17g3g56g81g79g72g86g86g3g82g87g75g72g85g90g76g86g72g3g86g83g72g70g76g191g72g71g15g3g81g82g3g83g68g85g87g3g82g73g3g87g75g76g86g3g83g88g69g79g76g70g68g87g76g82g81g3g80g68g92g3g69g72g3g

7、85g72g83g85g82g71g88g70g72g71g3g82g85g3g88g87g76g79g76g93g72g71g3g76g81g3g68g81g92g3g73g82g85g80g3g82g85g3g69g92g3g68g81g92g3g80g72g68g81g86g15g3g72g79g72g70g87g85g82g81g76g70g3g82g85g3g80g72g70g75g68g81g76g70g68g79g15g3g76g81g70g79g88g71g76g81g74g3g83g75g82g87g82g70g82g83g92g76g81g74g3g68g81g71g3g8

8、0g76g70g85g82g191g79g80g15g3g90g76g87g75g82g88g87g3g83g72g85g80g76g86g86g76g82g81g3g76g81g3g90g85g76g87g76g81g74g3g73g85g82g80g3g72g76g87g75g72g85g3g44g54g50g3g68g87g3g87g75g72g3g68g71g71g85g72g86g86g3g69g72g79g82g90g3g82g85g3g44g54g50g182g86g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g3g87g75g72g3g70

9、g82g88g81g87g85g92g3g82g73g3g87g75g72g3g85g72g84g88g72g86g87g72g85g17g44g54g50g3g70g82g83g92g85g76g74g75g87g3g82g73g191g70g72g38g68g86g72g3g83g82g86g87g68g79g72g3g24g25g3g135g3g38g43g16g20g21g20g20g3g42g72g81g72g89g68g3g21g19Tel. + 41 22 749 01 11Fax + 41 22 749 09 47g40g16g80g68g76g79g3g70g82g83g92

10、g85g76g74g75g87g35g76g86g82g17g82g85g74Web www.iso.orgg51g88g69g79g76g86g75g72g71g3g76g81g3g54g90g76g87g93g72g85g79g68g81g71BS ISO 11040-5:2012g3g44g54g50g3g20g20g19g23g19g16g24g29g21g19g20g21g11g40g12g41g82g85g72g90g82g85g71g44g54g50g3g11g87g75g72g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g50g85g74

11、g68g81g76g93g68g87g76g82g81g3g73g82g85g3g54g87g68g81g71g68g85g71g76g93g68g87g76g82g81g12g3g76g86g3g68g3g90g82g85g79g71g90g76g71g72g3g73g72g71g72g85g68g87g76g82g81g3g82g73g3g81g68g87g76g82g81g68g79g3g86g87g68g81g71g68g85g71g86g3g69g82g71g76g72g86g3g11g44g54g50g3 g80g72g80g69g72g85g3 g69g82g71g76g72g8

12、6g12g17g3 g55g75g72g3 g90g82g85g78g3 g82g73g3 g83g85g72g83g68g85g76g81g74g3 g44g81g87g72g85g81g68g87g76g82g81g68g79g3 g54g87g68g81g71g68g85g71g86g3 g76g86g3 g81g82g85g80g68g79g79g92g3 g70g68g85g85g76g72g71g3 g82g88g87g3 g87g75g85g82g88g74g75g3 g44g54g50g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g

13、87g87g72g72g86g17g3g40g68g70g75g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g87g72g85g72g86g87g72g71g3g76g81g3g68g3g86g88g69g77g72g70g87g3g73g82g85g3g90g75g76g70g75g3g68g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g3g75g68g86g3g69g72g72g81g3g72g86g87g68g69g79g76g86g75g72g71g3g75g68g86g3g87

14、g75g72g3g85g76g74g75g87g3g87g82g3g69g72g3g85g72g83g85g72g86g72g81g87g72g71g3g82g81g3g87g75g68g87g3g70g82g80g80g76g87g87g72g72g17g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g82g85g74g68g81g76g93g68g87g76g82g81g86g15g3g74g82g89g72g85g81g80g72g81g87g68g79g3g68g81g71g3g81g82g81g16g74g82g89g72g85g81g80g72

15、g81g87g68g79g15g3g76g81g3g79g76g68g76g86g82g81g3g90g76g87g75g3g44g54g50g15g3g68g79g86g82g3g87g68g78g72g3g83g68g85g87g3g76g81g3g87g75g72g3g90g82g85g78g17g3g44g54g50g3g70g82g79g79g68g69g82g85g68g87g72g86g3g70g79g82g86g72g79g92g3g90g76g87g75g3g87g75g72g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g40g79g7

16、2g70g87g85g82g87g72g70g75g81g76g70g68g79g3g38g82g80g80g76g86g86g76g82g81g3g11g44g40g38g12g3g82g81g3g68g79g79g3g80g68g87g87g72g85g86g3g82g73g3g72g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g86g87g68g81g71g68g85g71g76g93g68g87g76g82g81g17g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g8

17、5g71g86g3g68g85g72g3g71g85g68g73g87g72g71g3g76g81g3g68g70g70g82g85g71g68g81g70g72g3g90g76g87g75g3g87g75g72g3g85g88g79g72g86g3g74g76g89g72g81g3g76g81g3g87g75g72g3g44g54g50g18g44g40g38g3g39g76g85g72g70g87g76g89g72g86g15g3g51g68g85g87g3g21g17The main task of technical committees is to prepare Internati

18、onal Standards. Draft International Standards g68g71g82g83g87g72g71g3g69g92g3g87g75g72g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g3g68g85g72g3g70g76g85g70g88g79g68g87g72g71g3g87g82g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g73g82g85g3g89g82g87g76g81g74g17g3g51g88g69g79g76

19、g70g68g87g76g82g81g3g68g86g3g68g81g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g3g85g72g84g88g76g85g72g86g3g68g83g83g85g82g89g68g79g3g69g92g3g68g87g3g79g72g68g86g87g3g26g24g3g8g3g82g73g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g70g68g86g87g76g81g74g3g68g3g89g82g87g72g

20、17g36g87g87g72g81g87g76g82g81g3g76g86g3g71g85g68g90g81g3g87g82g3g87g75g72g3g83g82g86g86g76g69g76g79g76g87g92g3g87g75g68g87g3g86g82g80g72g3g82g73g3g87g75g72g3g72g79g72g80g72g81g87g86g3g82g73g3g87g75g76g86g3g71g82g70g88g80g72g81g87g3g80g68g92g3g69g72g3g87g75g72g3g86g88g69g77g72g70g87g3g82g73g3g83g68g8

21、7g72g81g87g3g85g76g74g75g87g86g17g3g44g54g50g3g86g75g68g79g79g3g81g82g87g3g69g72g3g75g72g79g71g3g85g72g86g83g82g81g86g76g69g79g72g3g73g82g85g3g76g71g72g81g87g76g73g92g76g81g74g3g68g81g92g3g82g85g3g68g79g79g3g86g88g70g75g3g83g68g87g72g81g87g3g85g76g74g75g87g86g17g44g54g50g3g20g20g19g23g19g16g24g3g90g

22、68g86g3g83g85g72g83g68g85g72g71g3g69g92g3g55g72g70g75g81g76g70g68g79g3g38g82g80g80g76g87g87g72g72g3g44g54g50g18g55g38g3g26g25g15g3Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.g55g75g76g86g3g87g75g76g85g71g3g72g71g76g87g76g82g81g3g70g68g81g70g

23、72g79g86g3g68g81g71g3g85g72g83g79g68g70g72g86g3g87g75g72g3g86g72g70g82g81g71g3g72g71g76g87g76g82g81g3g11g44g54g50g3g20g20g19g23g19g16g24g29g21g19g19g20g12g15g3g90g75g76g70g75g3g75g68g86g3g69g72g72g81g3g87g72g70g75g81g76g70g68g79g79g92g3g85g72g89g76g86g72g71g3g69g92g29g178g3 g68g71g77g88g86g87g76g81g

24、74g3g87g75g72g3g87g76g87g79g72g3g82g73g3g87g75g76g86g3g83g68g85g87g3g82g73g3g44g54g50g3g20g20g19g23g19g30g178g3 g68g79g76g74g81g76g81g74g3g87g75g76g86g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g3g90g76g87g75g3g87g75g72g3g44g54g50g3g27g27g26g20g3g86g72g85g76g72g86g30g178g3 g85

25、g72g89g76g86g76g81g74g3g87g75g72g3g85g72g84g88g76g85g72g80g72g81g87g86g3g82g81g3g87g75g72g3g75g72g76g74g75g87g3g82g73g3g87g75g72g3g86g83g68g70g72g85g86g3g68g81g71g3g85g72g84g88g76g85g72g80g72g81g87g86g3g82g81g3g80g68g87g72g85g76g68g79g3g68g81g71g3g75g68g85g71g81g72g86g86g30g178g3 g68g71g71g76g81g74g

26、3g85g72g84g88g76g85g72g80g72g81g87g86g3g82g81g3g85g72g86g76g86g87g68g81g70g72g3g87g82g3g68g74g72g76g81g74g17g44g54g50g3g20g20g19g23g19g3g70g82g81g86g76g86g87g86g3g82g73g3g87g75g72g3g73g82g79g79g82g90g76g81g74g3g83g68g85g87g86g15g3g88g81g71g72g85g3g87g75g72g3g74g72g81g72g85g68g79g3g87g76g87g79g72g3g5

27、1g85g72g191g79g79g72g71g3g86g92g85g76g81g74g72g86: g51g68g85g87g3g20g29g3g42g79g68g86g86g3g70g92g79g76g81g71g72g85g86g3g73g82g85g3g71g72g81g87g68g79g3g79g82g70g68g79g3g68g81g68g72g86g87g75g72g87g76g70g3g70g68g85g87g85g76g71g74g72g86 Part 2: Plunger stoppers for dental local anaesthetic cartridges Pa

28、rt 3: Seals for dental local anaesthetic cartridges g51g68g85g87g3g23g29g3g42g79g68g86g86g3g69g68g85g85g72g79g86g3g73g82g85g3g76g81g77g72g70g87g68g69g79g72g86g3g68g81g71g3g85g72g68g71g92g16g87g82g16g88g86g72g3g83g85g72g191g79g79g68g69g79g72g3g86g92g85g76g81g74g72g86 Part 5: Plunger stoppers for inje

29、ctables Part 6: Plastics barrels for injectables The following parts are under preparation: g51g68g85g87g3g26g29g3g51g68g70g78g68g74g76g81g74g3g86g92g86g87g72g80g86g3g73g82g85g3g83g85g72g191g79g79g68g69g79g72g3g85g72g68g71g92g16g87g82g16g88g86g72g3g86g92g85g76g81g74g72g86 ISO 2012 All rights reserve

30、d iii BS ISO 11040-5:2012g3g44g54g50g3g20g20g19g23g19g16g24g29g21g19g20g21g11g40g12g44g81g87g85g82g71g88g70g87g76g82g81g51g85g76g80g68g85g92g3g83g68g70g78g68g74g76g81g74g3g70g82g80g83g82g81g72g81g87g86g3g80g68g71g72g3g82g73g3g72g79g68g86g87g82g80g72g85g76g70g3g80g68g87g72g85g76g68g79g86g3g68g85g72g3

31、g68g81g3g76g81g87g72g74g85g68g79g3g83g68g85g87g3g82g73g3g80g72g71g76g70g76g81g68g79g3g83g85g82g71g88g70g87g86g17g3g55g75g72g85g72g73g82g85g72g15g3g87g75g72g3g83g85g76g81g70g76g83g79g72g86g3g82g73g3g70g88g85g85g72g81g87g3g74g82g82g71g3g80g68g81g88g73g68g70g87g88g85g76g81g74g3g83g85g68g70g87g76g70g72g

32、86g3g11g70g42g48g51g12g3g68g83g83g79g92g3g87g82g3g87g75g72g3g80g68g81g88g73g68g70g87g88g85g76g81g74g3g82g73g3g87g75g72g86g72g3g70g82g80g83g82g81g72g81g87g86g17g51g85g76g81g70g76g83g79g72g86g3g82g73g3g70g42g48g51g3g68g85g72g3g71g72g86g70g85g76g69g72g71g3g76g81g3g72g17g74g17g3g44g54g50g3g20g24g22g26g2

33、7g3g82g85g3g76g81g3g87g75g72g3g42g48g51g3g42g88g76g71g72g79g76g81g72g86g3g83g88g69g79g76g86g75g72g71g3g69g92g3g87g75g72g3g40g88g85g82g83g72g68g81g3g38g82g80g80g88g81g76g87g92g3g68g81g71g3g87g75g72g3g56g81g76g87g72g71g3g54g87g68g87g72g86g3g82g73g3g36g80g72g85g76g70g68g17ivg3 ISO 2012 All rights reser

34、ved BS ISO 11040-5:2012g3g51g85g72g191g79g79g72g71g3g86g92g85g76g81g74g72g86g3g178Part 5: g51g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g73g82g85g3g76g81g77g72g70g87g68g69g79g72g86g20g3 g54g70g82g83g72This part of ISO 11040g3g86g83g72g70g76g191g72g86g3g87g75g72g3g86g75g68g83g72g15g3g71g76g80g72g8

35、1g86g76g82g81g86g15g3g80g68g87g72g85g76g68g79g15g3g83g72g85g73g82g85g80g68g81g70g72g3g85g72g84g88g76g85g72g80g72g81g87g86g3g68g81g71g3g79g68g69g72g79g79g76g81g74g3g82g73g3g83g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g73g82g85g3g74g79g68g86g86g3g69g68g85g85g72g79g86g3g11g86g76g81g74g79g72g16g70g7

36、5g68g80g69g72g85g3g71g72g86g76g74g81g12g3g73g82g85g3g76g81g77g72g70g87g76g82g81g3g83g85g72g83g68g85g68g87g76g82g81g86g3g76g81g3g68g70g70g82g85g71g68g81g70g72g3g90g76g87g75g3ISO 11040-4.g51g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g86g83g72g70g76g191g72g71g3g76g81g3g87g75g76g86g3g83g68g85g87g3g82

37、g73g3g44g54g50g3g20g20g19g23g19g3g68g85g72g3g76g81g87g72g81g71g72g71g3g73g82g85g3g86g76g81g74g79g72g3g88g86g72g3g82g81g79g92g17This part of ISO 11040 is not applicable to barrier-coated plunger stoppers.g49g50g55g40g3 g55g75g72g3g83g82g87g72g81g70g92g15g3g83g88g85g76g87g92g15g3g86g87g68g69g76g79g76g

38、87g92g3g68g81g71g3g86g68g73g72g87g92g3g82g73g3g68g3g80g72g71g76g70g76g81g68g79g3g83g85g82g71g88g70g87g3g71g88g85g76g81g74g3g76g87g86g3g80g68g81g88g73g68g70g87g88g85g72g3g68g81g71g3g86g87g82g85g68g74g72g3g70g68g81g3g69g72g3g86g76g74g81g76g191g70g68g81g87g79g92g3g68g73g73g72g70g87g72g71g3g69g92g3g87g7

39、5g72g3g81g68g87g88g85g72g3g68g81g71g3g83g72g85g73g82g85g80g68g81g70g72g3g82g73g3g87g75g72g3g83g85g76g80g68g85g92g3g83g68g70g78g68g74g76g81g74g17g21g3 g49g82g85g80g68g87g76g89g72g3g85g72g73g72g85g72g81g70g72g86The following referenced documents are indispensable for the application of this document.

40、For dated g85g72g73g72g85g72g81g70g72g86g15g3g82g81g79g92g3g87g75g72g3g72g71g76g87g76g82g81g3g70g76g87g72g71g3g68g83g83g79g76g72g86g17g3g41g82g85g3g88g81g71g68g87g72g71g3g85g72g73g72g85g72g81g70g72g86g15g3g87g75g72g3g79g68g87g72g86g87g3g72g71g76g87g76g82g81g3g82g73g3g87g75g72g3g85g72g73g72g85g72g81g

41、70g72g71g3g71g82g70g88g80g72g81g87g3g11g76g81g70g79g88g71g76g81g74g3g68g81g92g3g68g80g72g81g71g80g72g81g87g86g12g3g68g83g83g79g76g72g86g17g44g54g50g3g22g22g19g21g16g20g15g3Rubber Tolerances for products Part 1: Dimensional tolerancesg44g54g50g3g26g25g20g28g16g20g15g3Rubber, vulcanized or thermoplast

42、ic Determination of indentation hardness Part 1: Durometer method (Shore hardness)g44g54g50g3g27g27g26g20g16g20g15g3Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavatesg44g54g50g3g27g27g26g20g16g23g15g3Elastomeric parts for parenterals

43、 and for devices for pharmaceutical use Part 4: Biological requirements and test methodsg44g54g50g3g20g20g19g23g19g16g23g15g3g51g85g72g191g79g79g72g71g3g86g92g85g76g81g74g72g86g3g178g3g51g68g85g87g3g23g29g3g42g79g68g86g86g3g69g68g85g85g72g79g86g3g73g82g85g3g76g81g77g72g70g87g68g69g79g72g86g22g3 g38g

44、79g68g86g86g76g191g70g68g87g76g82g81g51g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g86g75g68g79g79g3g69g72g3g70g79g68g86g86g76g191g72g71g3g68g86g3g73g82g79g79g82g90g86g29g178g3 g87g92g83g72g3g51g54g47g29g3g83g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g90g76g87g75g3g86g81g68g83g3g79g76g71g30g178

45、g3 g87g92g83g72g3g51g54g55g29g3g83g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g90g76g87g75g3g87g75g85g72g68g71g17g23g3 g54g75g68g83g72g3g68g81g71g3g71g76g80g72g81g86g76g82g81g86g23g17g20g3 The shape and dimensions of plunger stoppers shall be as shown in Figure 1 and given in Table 1.g44g49g55g40g

46、53g49g36g55g44g50g49g36g47g3g54g55g36g49g39g36g53g39g3 g44g54g50g3g20g20g19g23g19g16g24g29g21g19g20g21g11g40g12 ISO 2012 All rights reserved 1 BS ISO 11040-5:2012g3g44g54g50g3g20g20g19g23g19g16g24g29g21g19g20g21g11g40g12Dimensions in millimetresg68g12g3g3g3g51g79g88g81g74g72g85g3g86g87g82g83g83g72g8

47、5g3g90g76g87g75g3g86g81g68g83g3g79g76g71g3g11g51g54g47g12g49g50g55g40g3 g55g75g85g72g68g71g29g3g20g25g3g83g76g87g70g75g3g82g81g3g21g24g15g23g3g80g80g30g3g73g82g85g3g20g3g80g79g3g11g79g82g81g74g12g15g3g20g26g3g83g76g87g70g75g3g82g81g3g21g24g15g23g3g80g80g17g69g12g3g3g3g51g79g88g81g74g72g85g3g86g87g82

48、g83g83g72g85g3g90g76g87g75g3g87g75g85g72g68g71g3g11g51g54g55g12g54g75g68g83g72g3g68g81g71g3g71g76g80g72g81g86g76g82g81g86g3g82g73g3g83g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86g3g73g82g85g3g68g3g83g85g72g191g79g79g72g71g3g86g92g85g76g81g74g72g21g3 ISO 2012 All rights reserved BS ISO 11040-5:2012g3g44g54g50g3g20g20g19g23g19g16g24g29g21g19g20g21g11g40g12g39g76g80g72g81g86g76g82g81g86g3g82g73g3g83g79g88g81g74g72g85g3g86g87g82g83g83g72g85g86Dimensions in millimetresg49g82g80g76g81g68g79g3g76g81g81g72g85g3g71g76g68g80g72g87g72g85g49g82g80