DS/EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity


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 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or trough diffusion a) with extracts of a device , and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.


Number of pages: 52

Published: 2009-07-24

Date of approval: 2009-07-14

International relationships : EN ISO 10993-5:2009 IDT ISO 10993-5:2009 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: M220634


Committees

Committee

  • CEN/TC 206
  • ISO/TC 194/WG 5

Danish committee

DS/S-258