DS/EN ISO 11138-5:2006 ( Withdrawn )

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 45.80

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 low-temperature-steam-formaldehyde as the sterilizing agent.
NOTE 1 – Requirements for validation and monitoring of low-temperature-steam-formaldehyde sterilization processes are provided by ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
NOTE 2 – Requirements for work place safety may be provided by national or regional regulations.


Number of pages: 20

Published: 2006-09-27

Date of approval: 2006-07-14

Date of withdrawal: 2017-04-05

International relationships : EN ISO 11138-5:2006 IDT ISO 11138-5:2006 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: 55895


Committees

Committee

  • CEN/TC 102
  • ISO/TC 198/WG 4

Danish committee

DS/S-259