DS/EN ISO 11135-1:2007 ( Withdrawn )

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
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 standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.


Number of pages: 56

Published: 2007-07-30

Date of approval: 2007-06-14

Date of withdrawal: 2017-07-31

International relationships : EN ISO 11135-1:2007 IDT ISO 11135-1:2007 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: 55671


Committees

Committee

  • CEN/TC 204
  • ISO/TC 198/WG 1

Danish committee

DS/S-259