DS/EN ISO 11138-5:2017

Sterilization of health care products – Biological indicators – Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.80

Scope

ISO 11138-5:2017 specifies 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 and formaldehyde as the sterilizing agent.

NOTE 1 – Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.

NOTE 2 – Requirements for work place safety can be provided by national or regional regulations.


Number of pages: 20

Published: 2017-04-05

Date of approval: 2017-04-04

International relationships : EN ISO 11138-5:2017 IDT ISO 11138-5:2017 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: M300714


Committees

Committee

  • CEN/TC 102
  • ISO/TC 198
  • ISO/TC 198
  • ISO/TC 198/WG 4
  • ISO/TC 198/WG 4

Danish committee

DS/S-259