DS/EN ISO 11138-2:2009 ( Withdrawn )

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 45.79
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 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 – Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.
NOTE 2 – National or regional regulations could provide requirements for work place safety.


Number of pages: 20

Published: 2009-07-02

Date of approval: 2009-06-11

Date of withdrawal: 2017-04-05

International relationships : EN ISO 11138-2:2009 IDT ISO 11138-2:2006 IDT

ICS: 11.080.01 - Sterilization and disinfection in general 11.080.20 - Disinfectants and antiseptics

Item number: M235352


Committees

Committee

  • CEN/TC 102
  • ISO/TC 198/WG 4

Danish committee

DS/S-259