DS/EN ISO 10993-6:2009 ( Withdrawn )

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 74.63
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 test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
This part of ISO 10993 applies to materials that are:
- solid and non-biodegradable;
- degradable and/or resorbable
- non-solid, such as porous materials, liquids, pastes and particulates.


Number of pages: 40

Published: 2009-07-24

Date of approval: 2009-07-02

Date of withdrawal: 2017-01-04

International relationships : EN ISO 10993-6:2009 IDT ISO 10993-6:2007 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: M235521


Committees

Committee

  • CEN/TC 206
  • ISO/TC 194/WG 10

Danish committee

DS/S-258