DS/EN ISO 11138-2:2017

Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)


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 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

NOTE 1 – Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.

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


Number of pages: 20

Published: 2017-04-05

Date of approval: 2017-04-04

International relationships : EN ISO 11138-2:2017 IDT ISO 11138-2:2017 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: M300722


Committees

Committee

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

Danish committee

DS/S-259