DS/EN ISO 11138-3:2009 ( Withdrawn )

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Sundhed
Replaced by:
Price from:
€ 45.84
Legislation:

CE Harmonized

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 sterilization processes employing moist heat as the sterilizing agent.
Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.
NOTE 1 – Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.
NOTE 2 – National or regional regulations may provide requirements for work place safety.

Replaces:

Number of pages: 20

Published: 2009-07-02

Date of approval: 2009-06-11

Date of withdrawal: 2017-04-05

International relationships : EN ISO 11138-3:2009 IDT ISO 11138-3:2006 IDT

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

Item number: M235353

Committees

Committee

  • CEN/TC 102
  • ISO/TC 198/WG 4

Danish committee

DS/S-259