DS/EN 556-1/AC:2006

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


Status:
Current
Type:
Correction sheet
Language:
English
Subject:
Price from:
€ 0.00
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

Corrigendum to EN 556-1:2001:
This standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE".

Number of pages: 8

Published: 2006-12-21

Date of approval: 2006-10-19

International relationships : EN 556-1:2001/AC:2006 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: M216227


Committees

Committee

  • CEN/TC 204/WG 6

Danish committee

DS/S-259