DS/EN ISO 11138-4:2017

Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)


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

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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to
180 °C.
NOTE 1 – Requirements for validation and control of dry heat sterilization processes are provided by ISO 14937.
NOTE 2 – Requirements for work place safety may be provided by national or regional regulations.


Number of pages: 22

Published: 2017-04-05

Date of approval: 2017-04-04

International relationships : EN ISO 11138-4:2017 IDT ISO 11138-4:2017 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: M300721


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