Norm

NEN-EN-ISO 10993-3:2000 Ontw. en

Biologische evaluatie van medische hulpmiddelen - Deel 3: Beproevingen op genotoxiciteit, carcinogeniteit en voortplantingstoxiciteit

  • Deze norm is ingetrokken sinds 01-12-2003

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 15
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-05-2000
Taal Engels
This part of ISO 10993 specifies tests for the following biological aspects; - genotoxicity, - carcinogenicity, and - reproductive and development toxicity. These tests are relevant in the biological evaluation of some categories of medical devices. Guidance on selection of tests is provided in ISO 10993-1. Where the need for the evaluation of the potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified, it should be evaluated in accordance with this part of ISO 10993. Most tests included in this part of ISO 10993 refer to the Guidelines for Testing of Chemicals, prepared by the Organisation for Economic Co-operation and Development (OECD). Reference to these OECD test guidelines is made by the term "OECD" followed by the appropriate test number(s).

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 3: Beproevingen op genotoxiciteit, carcinogeniteit en voortplantingstoxiciteit
Engelse titel Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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