BS ISO 6474-2-2012 Implants for surgery Ceramic materials Composite materials based on a high-purity alumina matrix with zirconia reinforcement《外科植入物 陶瓷材料 氧化锆增强的高纯氧化铝基复合材料》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 6474-2:2012Implants for surgery CeramicmaterialsPart 2: Composite materials based on ahigh-purity alumina matrix with zirconiareinforcementBS ISO 6474-2:2012 BRITISH STAND

2、ARDNational forewordThis British Standard is the UK implementation of ISO 6474-2:2012.Together with BS ISO 6474-1:2010 it supersedes BS 7253-2:1997,which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery to Subcommittee CH/150/1, M

3、aterials for surgical implants.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institut

4、ion 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 66325 3ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2012.Amendments/corri

5、genda issued since publicationDate Text affected ISO 2012Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcementImplants chirurgicaux Produits cramiques Partie 2: Matriaux composites matrice alumine de haute puret renforce

6、par des grains de zirconeINTERNATIONAL STANDARDISO6474-2First edition2012-04-15Reference numberISO 6474-2:2012(E)BS ISO 6474-2:2012ISO 6474-2:2012(E)ii ISO 2012 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2012g36g79g79g3g85g76g74g75g87g86g3g85g72g86g72g85g89g72g71g17g3g56g81g79g72g86g86g3g82

7、g87g75g72g85g90g76g86g72g3g86g83g72g70g76g191g72g71g15g3g81g82g3g83g68g85g87g3g82g73g3g87g75g76g86g3g83g88g69g79g76g70g68g87g76g82g81g3g80g68g92g3g69g72g3g85g72g83g85g82g71g88g70g72g71g3g82g85g3g88g87g76g79g76g93g72g71g3g76g81g3g68g81g92g3g73g82g85g80g3g82g85g3g69g92g3g68g81g92g3g80g72g68g81g86g15g3

8、g72g79g72g70g87g85g82g81g76g70g3g82g85g3g80g72g70g75g68g81g76g70g68g79g15g3g76g81g70g79g88g71g76g81g74g3g83g75g82g87g82g70g82g83g92g76g81g74g3g68g81g71g3g80g76g70g85g82g191g79g80g15g3g90g76g87g75g82g88g87g3g83g72g85g80g76g86g86g76g82g81g3g76g81g3g90g85g76g87g76g81g74g3g73g85g82g80g3g72g76g87g75g72g8

9、5g3g44g54g50g3g68g87g3g87g75g72g3g68g71g71g85g72g86g86g3g69g72g79g82g90g3g82g85g3g44g54g50g182g86g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g3g87g75g72g3g70g82g88g81g87g85g92g3g82g73g3g87g75g72g3g85g72g84g88g72g86g87g72g85g17g44g54g50g3g70g82g83g92g85g76g74g75g87g3g82g73g191g70g72g38g68g86g72g3g83g82

10、g86g87g68g79g72g3g24g25g3g135g3g38g43g16g20g21g20g20g3g42g72g81g72g89g68g3g21g19Tel. + 41 22 749 01 11Fax + 41 22 749 09 47g40g16g80g68g76g79g3g70g82g83g92g85g76g74g75g87g35g76g86g82g17g82g85g74Web www.iso.orgg51g88g69g79g76g86g75g72g71g3g76g81g3g54g90g76g87g93g72g85g79g68g81g71BS ISO 6474-2:2012ISO

11、 6474-2:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative references . 1g22g3 g38g79g68g86g86g76g191g70g68g87g76g82g81 33.1 Material types . 33.2 Test categories . 33.3 Material properties 34 Preparation of specimens . 55 Test methods 65.1 Bulk densit

12、y 65.2 Chemical composition . 75.3 Microstructure 75.4 Strength properties . 85.5 Radioactivity . 95.6 Fracture toughness . 95.7 Hardness 95.8 Youngs modulus . 95.9 Cyclic fatigue 105.10 Accelerated ageing .10Bibliography .12BS ISO 6474-2:2012ISO 6474-2:2012(E)Forewordg44g54g50g3g11g87g75g72g3g44g81

13、g87g72g85g81g68g87g76g82g81g68g79g3g50g85g74g68g81g76g93g68g87g76g82g81g3g73g82g85g3g54g87g68g81g71g68g85g71g76g93g68g87g76g82g81g12g3g76g86g3g68g3g90g82g85g79g71g90g76g71g72g3g73g72g71g72g85g68g87g76g82g81g3g82g73g3g81g68g87g76g82g81g68g79g3g86g87g68g81g71g68g85g71g86g3g69g82g71g76g72g86g3g11g44g54

14、g50g3 g80g72g80g69g72g85g3 g69g82g71g76g72g86g12g17g3 g55g75g72g3 g90g82g85g78g3 g82g73g3 g83g85g72g83g68g85g76g81g74g3 g44g81g87g72g85g81g68g87g76g82g81g68g79g3 g54g87g68g81g71g68g85g71g86g3 g76g86g3 g81g82g85g80g68g79g79g92g3 g70g68g85g85g76g72g71g3 g82g88g87g3 g87g75g85g82g88g74g75g3 g44g54g50g3g

15、87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g17g3g40g68g70g75g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g87g72g85g72g86g87g72g71g3g76g81g3g68g3g86g88g69g77g72g70g87g3g73g82g85g3g90g75g76g70g75g3g68g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g3g75g68g86g3g69g72g72g81g3g72g8

16、6g87g68g69g79g76g86g75g72g71g3g75g68g86g3g87g75g72g3g85g76g74g75g87g3g87g82g3g69g72g3g85g72g83g85g72g86g72g81g87g72g71g3g82g81g3g87g75g68g87g3g70g82g80g80g76g87g87g72g72g17g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g82g85g74g68g81g76g93g68g87g76g82g81g86g15g3g74g82g89g72g85g81g80g72g81g87g68g79g3g68

17、g81g71g3g81g82g81g16g74g82g89g72g85g81g80g72g81g87g68g79g15g3g76g81g3g79g76g68g76g86g82g81g3g90g76g87g75g3g44g54g50g15g3g68g79g86g82g3g87g68g78g72g3g83g68g85g87g3g76g81g3g87g75g72g3g90g82g85g78g17g3g44g54g50g3g70g82g79g79g68g69g82g85g68g87g72g86g3g70g79g82g86g72g79g92g3g90g76g87g75g3g87g75g72g3g44g8

18、1g87g72g85g81g68g87g76g82g81g68g79g3g40g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g38g82g80g80g76g86g86g76g82g81g3g11g44g40g38g12g3g82g81g3g68g79g79g3g80g68g87g87g72g85g86g3g82g73g3g72g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g86g87g68g81g71g68g85g71g76g93g68g87g76g82g81g17g44g81g87g72g85g8

19、1g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g86g3g68g85g72g3g71g85g68g73g87g72g71g3g76g81g3g68g70g70g82g85g71g68g81g70g72g3g90g76g87g75g3g87g75g72g3g85g88g79g72g86g3g74g76g89g72g81g3g76g81g3g87g75g72g3g44g54g50g18g44g40g38g3g39g76g85g72g70g87g76g89g72g86g15g3g51g68g85g87g3g21g17The main task of

20、technical committees is to prepare International Standards. Draft International Standards g68g71g82g83g87g72g71g3g69g92g3g87g75g72g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g3g68g85g72g3g70g76g85g70g88g79g68g87g72g71g3g87g82g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g73g8

21、2g85g3g89g82g87g76g81g74g17g3g51g88g69g79g76g70g68g87g76g82g81g3g68g86g3g68g81g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g3g85g72g84g88g76g85g72g86g3g68g83g83g85g82g89g68g79g3g69g92g3g68g87g3g79g72g68g86g87g3g26g24g3g8g3g82g73g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g8

22、6g3g70g68g86g87g76g81g74g3g68g3g89g82g87g72g17g36g87g87g72g81g87g76g82g81g3g76g86g3g71g85g68g90g81g3g87g82g3g87g75g72g3g83g82g86g86g76g69g76g79g76g87g92g3g87g75g68g87g3g86g82g80g72g3g82g73g3g87g75g72g3g72g79g72g80g72g81g87g86g3g82g73g3g87g75g76g86g3g71g82g70g88g80g72g81g87g3g80g68g92g3g69g72g3g87g75

23、g72g3g86g88g69g77g72g70g87g3g82g73g3g83g68g87g72g81g87g3g85g76g74g75g87g86g17g3g44g54g50g3g86g75g68g79g79g3g81g82g87g3g69g72g3g75g72g79g71g3g85g72g86g83g82g81g86g76g69g79g72g3g73g82g85g3g76g71g72g81g87g76g73g92g76g81g74g3g68g81g92g3g82g85g3g68g79g79g3g86g88g70g75g3g83g68g87g72g81g87g3g85g76g74g75g87

24、g86g17ISO 6474-2g3g90g68g86g3g83g85g72g83g68g85g72g71g3g69g92g3g55g72g70g75g81g76g70g68g79g3g38g82g80g80g76g87g87g72g72g3ISO/TCg3g20g24g19g15g3Implants for surgeryg15g3g54g88g69g70g82g80g80g76g87g87g72g72g3g54g38g3g20g15g3Materials.g44g54g50g3g25g23g26g23g3g70g82g81g86g76g86g87g86g3g82g73g3g87g75g72

25、g3g73g82g79g79g82g90g76g81g74g3g83g68g85g87g86g15g3g88g81g71g72g85g3g87g75g72g3g74g72g81g72g85g68g79g3g87g76g87g79g72g3Implants for surgery Ceramic materials: Part 1: Ceramic materials based on high purity alumina Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinfo

26、rcementiv ISO 2012 All rights reserved BS ISO 6474-2:2012ISO 6474-2:2012(E)Introductiong49g82g3g78g81g82g90g81g3g86g88g85g74g76g70g68g79g3g76g80g83g79g68g81g87g3g80g68g87g72g85g76g68g79g3g75g68g86g3g72g89g72g85g3g69g72g72g81g3g73g82g88g81g71g3g87g82g3g69g72g3g70g82g80g83g79g72g87g72g79g92g3g73g85g72

27、g72g3g82g73g3g68g71g89g72g85g86g72g3g85g72g68g70g87g76g82g81g86g3g76g81g3g87g75g72g3g75g88g80g68g81g3g69g82g71g92g17g3g43g82g90g72g89g72g85g15g3g79g82g81g74g16g87g72g85g80g3g70g79g76g81g76g70g68g79g3g72g91g83g72g85g76g72g81g70g72g3g82g73g3g88g86g72g3g82g73g3g68g79g88g80g76g81g68g3g68g81g71g3g93g76g8

28、5g70g82g81g76g68g3g11g87g75g72g3g80g68g76g81g3g70g82g80g83g82g81g72g81g87g86g3g82g73g3the material referred to in this part of ISO 6474) as biomaterials has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications. ISO 2012 All right

29、s reserved v BS ISO 6474-2:2012BS ISO 6474-2:2012Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement1 Scopeg55g75g76g86g3g83g68g85g87g3g82g73g3g44g54g50g3g25g23g26g23g3g86g83g72g70g76g191g72g86g3g87g75g72g3g70g75g68g85g

30、68g70g87g72g85g76g86g87g76g70g86g3g82g73g15g3g68g81g71g3g70g82g85g85g72g86g83g82g81g71g76g81g74g3g87g72g86g87g3g80g72g87g75g82g71g86g3g73g82g85g15g3g68g3g69g76g82g70g82g80g83g68g87g76g69g79g72g3g68g81g71g3 g69g76g82g86g87g68g69g79g72g3 g70g72g85g68g80g76g70g16g69g82g81g72g16g86g88g69g86g87g76g87g88g

31、87g72g3 g80g68g87g72g85g76g68g79g3 g69g68g86g72g71g3 g82g81g3 g68g3 g93g76g85g70g82g81g76g68g16g85g72g76g81g73g82g85g70g72g71g15g3 g75g76g74g75g16g83g88g85g76g87g92g3 g68g79g88g80g76g81g68g3 g80g68g87g85g76g91g3g70g82g80g83g82g86g76g87g72g3g73g82g85g3g88g86g72g3g68g86g3g68g3g70g82g80g83g82g81g72g81g

32、87g3g76g81g3g82g85g87g75g82g83g68g72g71g76g70g3g77g82g76g81g87g3g83g85g82g86g87g75g72g86g72g86g17g55g75g76g86g3g83g68g85g87g3g82g73g3g44g54g50g3g25g23g26g23g3g76g86g3g76g81g87g72g81g71g72g71g3g73g82g85g3g70g82g80g83g82g86g76g87g72g3g80g68g87g72g85g76g68g79g86g3g90g75g76g70g75g3g68g85g72g3g69g68g86g7

33、2g71g3g82g81g3g68g81g3g68g79g88g80g76g81g68g3g80g68g87g85g76g91g15g3g76g17g72g17g3g68g79g88g80g76g81g68g3as the dominating phase in the composite with a mass fraction of g33g3g25g19g3g8g15g3g86g76g80g76g79g68g85g3g87g82g3g87g75g72g3g80g68g87g72g85g76g68g79g3g71g72g86g70g85g76g69g72g71g3g76g81g3g44g5

34、4g50g3g25g23g26g23g16g20g15g3g69g88g87g3g72g91g87g72g81g71g72g71g3g69g92g3g80g72g68g81g86g3g82g73g3g68g3g70g72g85g87g68g76g81g3g68g80g82g88g81g87g3g82g73g3g93g76g85g70g82g81g76g68g3g68g81g71g3g82g87g75g72g85g3g71g72g191g81g72g71g3g76g81g74g85g72g71g76g72g81g87g86g17g49g50g55g40g3 g55g75g72g3g85g72g8

35、4g88g76g85g72g71g3g83g85g82g83g72g85g87g76g72g86g3g76g81g3g87g75g76g86g3g83g68g85g87g3g82g73g3ISO 6474 differ from those in ISO 6474-1 with respect to strength and fracture g87g82g88g74g75g81g72g86g86g17g3g41g88g85g87g75g72g85g80g82g85g72g15g3g87g75g72g85g72g3g68g85g72g3g85g72g84g88g76g85g72g80g72g8

36、1g87g86g3g86g83g72g70g76g191g70g68g79g79g92g3g68g83g83g79g76g70g68g69g79g72g3g73g82g85g3g93g76g85g70g82g81g76g68g16g70g82g81g87g68g76g81g76g81g74g3g80g68g87g72g85g76g68g79g86g3g11g86g72g72g3ISO 13356).g44g81g3g87g75g72g3g80g68g87g72g85g76g68g79g3g70g82g80g83g82g86g76g87g76g82g81g3g68g86g3g71g72g191g

37、81g72g71g3g76g81g3g87g75g76g86g3g83g68g85g87g3g82g73g3g44g54g50g3g25g23g26g23g15g3g68g71g71g76g87g76g82g81g68g79g3g68g71g71g76g87g76g89g72g86g3g68g85g72g3g79g76g86g87g72g71g17g3g55g92g83g76g70g68g79g3g68g71g71g76g87g76g89g72g86g3g73g82g85g3g68g79g88g80g76g81g68g3g82g85g3g93g76g85g70g82g81g76g68g3g70

38、g72g85g68g80g76g70g86g3g68g85g72g3g48g74g15g3g60g15g3g38g72g3g68g81g71g3g82g87g75g72g85g86g17g3g54g88g70g75g3g68g71g71g76g87g76g89g72g86g3g70g68g81g3g69g72g3g88g86g72g73g88g79g3g76g81g3g82g85g71g72g85g3g87g82g3g76g80g83g85g82g89g72g3g87g75g72g3g80g72g70g75g68g81g76g70g68g79g3g83g85g82g83g72g85g87g76

39、g72g86g3g68g81g71g18g82g85g3g87g75g72g3g70g75g72g80g76g70g68g79g3g86g87g68g69g76g79g76g87g92g3g82g73g3g87g75g72g3g68g79g88g80g76g81g68g16g93g76g85g70g82g81g76g68g3g70g82g80g83g82g86g76g87g72g3g80g68g87g72g85g76g68g79g17g3g55g75g76g86g3g83g68g85g87g3g82g73g3g44g54g50g3g25g23g26g23g3g71g82g72g86g3g81g

40、82g87g3g70g82g89g72g85g3g87g75g72g3g69g76g82g70g82g80g83g68g87g76g69g76g79g76g87g92g3g11g86g72g72g3g44g54g50g3g20g19g28g28g22g16g20g12g3g82g73g3g87g75g72g86g72g3g76g81g82g85g74g68g81g76g70g3g68g71g71g76g87g76g89g72g86g3g76g81g3g87g75g72g3g75g88g80g68g81g3g69g82g71g92g17g3g44g87g3g76g86g3g87g75g72g3g

41、85g72g86g83g82g81g86g76g69g76g79g76g87g92g3g82g73g3g87g75g72g3g80g68g81g88g73g68g70g87g88g85g72g85g3g87g82g3g72g89g68g79g88g68g87g72g3g87g75g72g3g69g76g82g70g82g80g83g68g87g76g69g76g79g76g87g92g3g82g73g3g87g75g72g3g86g83g72g70g76g191g70g3g70g72g85g68g80g76g70g3g70g82g80g83g82g86g76g87g72g3material w

42、hich is produced within the framework of this part of ISO 6474.2 Normative referencesg55g75g72g3g73g82g79g79g82g90g76g81g74g3g71g82g70g88g80g72g81g87g86g15g3g76g81g3g90g75g82g79g72g3g82g85g3g76g81g3g83g68g85g87g15g3g68g85g72g3g81g82g85g80g68g87g76g89g72g79g92g3g85g72g73g72g85g72g81g70g72g71g3g76g81g

43、3g87g75g76g86g3g71g82g70g88g80g72g81g87g3g68g81g71g3g68g85g72g3g76g81g71g76g86g83g72g81g86g68g69g79g72g3g73g82g85g3g76g87g86g3g68g83g83g79g76g70g68g87g76g82g81g17g3g41g82g85g3g71g68g87g72g71g3g85g72g73g72g85g72g81g70g72g86g15g3g82g81g79g92g3g87g75g72g3g72g71g76g87g76g82g81g3g70g76g87g72g71g3g68g83g8

44、3g79g76g72g86g17g3g41g82g85g3g88g81g71g68g87g72g71g3g85g72g73g72g85g72g81g70g72g86g15g3g87g75g72g3g79g68g87g72g86g87g3g72g71g76g87g76g82g81g3g82g73g3g87g75g72g3g85g72g73g72g85g72g81g70g72g71g3g71g82g70g88g80g72g81g87g3g11g76g81g70g79g88g71g76g81g74g3g68g81g92g3g68g80g72g81g71g80g72g81g87g86g12g3g68g

45、83g83g79g76g72g86g17g44g54g50g3g20g21g25g26g26g15g3g38g75g72g80g76g70g68g79g3g68g81g68g79g92g86g76g86g3g82g73g3g85g72g73g85g68g70g87g82g85g92g3g83g85g82g71g88g70g87g86g3g69g92g3g59g16g85g68g92g3g192g88g82g85g72g86g70g72g81g70g72g3g11g59g53g41g12g3g178g3g41g88g86g72g71g3g70g68g86g87g3g69g72g68g71g3g8

46、0g72g87g75g82g71g44g54g50g3g20g22g22g24g25g15g3g44g80g83g79g68g81g87g86g3g73g82g85g3g86g88g85g74g72g85g92g3g178g3g38g72g85g68g80g76g70g3g80g68g87g72g85g76g68g79g86g3g69g68g86g72g71g3g82g81g3g92g87g87g85g76g68g16g86g87g68g69g76g79g76g93g72g71g3g87g72g87g85g68g74g82g81g68g79g3g93g76g85g70g82g81g76g68g

47、3g11g60g16g55g61g51g12g44g54g50g3g20g23g21g23g21g16g20g15g3Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testg44g54g50g3g20g23g21g23g22g16g20g15g3Implants for surgery Wear o

48、f total knee-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for testg44g54g50g3 g20g23g26g19g23g15g3 g41g76g81g72g3 g70g72g85g68g80g76g70g86g3 g11g68g71g89g68g81g70g72g71g3 g70g72g85g68g80g76g70g86g1

49、5g3 g68g71g89g68g81g70g72g71g3 g87g72g70g75g81g76g70g68g79g3 g70g72g85g68g80g76g70g86g12g3 g178g3 g55g72g86g87g3 g80g72g87g75g82g71g3 g73g82g85g3 g192g72g91g88g85g68g79g3strength of monolithic ceramics at room temperatureg44g54g50g3g20g23g26g19g24g15g3g41g76g81g72g3g70g72g85g68g80g76g70g86g3g11g68g71g89g68g81g70g72g71g3g70g72g85g68g80g76g70g86g15g3g68g71g89g68g81g70g72g71g3g87g72g7