DS/EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "Sterile" - Part 1: Requirements for terminally sterilized medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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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

  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

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

Harmonized standards:
Links

Scope

This standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE".


Number of pages: 12

Published: 2002-01-10

Date of approval: 2001-12-19

International relationships : EN 556-1:2001 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: 41505


Committees

Committee

  • CEN/TC 204/WG 6

Danish committee

DS/S-259