DS/EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

Legislation

Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
- genotoxicity,
- carcinogenicity and
- reproductive and developmental toxicity.
This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
NOTE – Guidance on selection of tests is provided in ISO 10993-1.


Number of pages: 50

Published: 2014-11-27

Date of approval: 2014-11-18

International relationships : EN ISO 10993-3:2014 IDT ISO 10993-3:2014 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: M256418


Committees

Committee

  • CEN/TC 206
  • ISO/TC 194
  • ISO/TC 194/WG 6

Danish committee

DS/S-258