BS EN ISO 10993-3:2003 - Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity – BSI British Standards

BS EN ISO 10993-3:2003

Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity

Status : Revised, Withdrawn   Published : October 2003 Replaced By : BS EN ISO 10993-3:2009

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BS EN ISO 10993-3 specifies strategies for hazard identification and tests on medical devices for the biological aspects of genotoxicity, carcinogenicity, and reproductive and developmental toxicity. It is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Guidance on selection of tests is provided in BS EN ISO 10993-1.




Standard NumberBS EN ISO 10993-3:2003
TitleBiological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
StatusRevised, Withdrawn
Publication Date31 October 2003
Withdrawn Date30 June 2009
Normative References(Required to achieve compliance to this standard)ISO 10993-1:1997, ISO 10993-2:1992, ISO 10993-6:1994, ISO 10993-12:2002, ISO 10993-18, OECD 414, OECD 415, OECD 416, OECD 421, OECD 451, OECD 453, OECD 471, OECD 473, OECD 476, EN ISO 10993-2:1998, EN ISO 10993-12:1996, ISO 10993-12:1996
Informative References(Provided for Information)OECD 474, OECD 475, OECD 478, OECD 479, OECD 480, OECD 481, OECD 482, OECD 483, OECD 484, OECD 485, OECD 486, ASTM F 1439-39
Replaced ByBS EN ISO 10993-3:2009
ReplacesBS EN 30993-3:1994, ISO 10993-3:1992
International RelationshipsEN ISO 10993-3:2003,ISO 10993-3:2003
Amended ByAMD 14920
AMD 14920 is a Corrigendum.
Draft Superseded By00/561676 DC
DescriptorsMedical equipment, Biological analysis and testing, Medical instruments, Dental equipment, Implants (surgical), Biological hazards, Toxic materials, Toxicity, Genotoxicity tests, Cytotoxicity tests, Reproductive system
ICS11.100.20
Title in FrenchEvaluation biologique des dispositifs medicaux. Essais concernant la genotoxicite, la cancerogenicite et la toxicite sur la reproduction
Title in GermanBiologische Beurteilung von Medizinprodukten. Pruefungen auf Gentoxizitaet, Karzinogenitaet und Reproduktionstoxizitaet
CommitteeCH/194
ISBN0 580 42881 8
PublisherBSI
FormatA4
DeliveryNo
Pages28
File Size575.3 KB
Price£186.00


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