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DIN EN ISO 11138-1

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)

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Organization: DIN
Publication Date: 1 September 2006
Status: inactive
Page Count: 46
ICS Code (Disinfectants and antiseptics): 11.080.20

Document History

DIN EN ISO 11138-1
July 1, 2017
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
DIN EN ISO 11138-1
October 1, 2015
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO/DIS 11138-1:2015); German and English version prEN ISO 11138-1:2015
A description is not available for this item.
DIN EN ISO 11138-1
September 1, 2006
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
A description is not available for this item.

References

This document is referenced by:
DIN EN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Published by DIN on September 1, 2014
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient...
This document is referenced by:
DIN EN 1422 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Published by DIN on August 1, 2014
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture...
This document is referenced by:
DIN EN ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
Published by DIN on April 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN ISO 15883-1 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014) (includes Amendment A1:2014)
Published by DIN on October 1, 2014
This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical...
This document is referenced by:
DIN EN ISO 11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
Published by DIN on March 1, 2015
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and...
This document is referenced by:
DIN EN ISO 20857 - Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
Published by DIN on August 1, 2013
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of...
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