DS/EN ISO 10993-4:2009 ( Withdrawn )

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 104.75
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 standard provides general requirements for evaluating the interactions of medical devices with blood. It describes
a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.


Number of pages: 64

Published: 2009-07-02

Date of approval: 2009-06-15

Date of withdrawal: 2017-05-18

International relationships : EN ISO 10993-4:2009 IDT ISO 10993-4:2002 IDT

ICS: 11.100.01 - Laboratory medicine in general 11.100.20 - Biological evaluation of medical devices

Item number: M235509


Committees

Committee

  • CEN/TC 206
  • ISO/TC 194/WG 9

Danish committee

DS/S-258