DS/EN ISO 11138-3:2017

Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

NOTE 1 – Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.

NOTE 2 – National or regional regulations can provide requirements for work place safety.


Number of pages: 22

Published: 2017-04-05

Date of approval: 2017-04-04

International relationships : EN ISO 11138-3:2017 IDT ISO 11138-3:2017 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: M300716


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