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BSI - BS EN ISO 11138-2

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

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Organization: BSI
Publication Date: 31 July 2006
Status: inactive
Page Count: 16
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 11138-2
April 30, 2017
Sterilization of health care products — Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
A description is not available for this item.
BS EN ISO 11138-2
November 30, 2009
Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
A description is not available for this item.
BS EN ISO 11138-2
July 31, 2006
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
A description is not available for this item.

References

This document references:
ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on July 15, 2014
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial...
This document references:
93/42/EEC - Council Directive Concerning Medical Devices
Published by EU on June 14, 1993
Definitions, scope 1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both...
This document references:
ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
Published by ISO on March 1, 2017
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
This document references:
ISO 18472 - Sterilization of health care products - Biological and chemical indicators - Test equipment
Published by ISO on August 1, 2018
This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the...
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