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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)

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Organization: DIN
Publication Date: 1 April 2020
Status: active
Page Count: 105
ICS Code (Disinfectants and antiseptics): 11.080.20

Document History

DIN EN ISO 11135
May 1, 2023
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023
A description is not available for this item.
DIN EN ISO 11135
April 1, 2020
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)
A description is not available for this item.
DIN EN ISO 11135/A1
September 1, 2017
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/DAM 1:2017); German and English version EN ISO 11135:2014/prA1:2017
A description is not available for this item.
DIN EN ISO 11135
October 1, 2014
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)
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...

References

This document references:
ISO 15883-1 - Washer-disinfectors Part 1: General requirements, terms and definitions and tests
Published by ISO on April 15, 2006
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 references:
ISO 14040 - Environmental management — Life cycle assessment — Principles and framework AMENDMENT 1
Published by ISO on September 1, 2020
A description is not available for this item.
This document references:
ISO 22442-3 - Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Published by ISO on December 15, 2007
A description is not available for this item.
This document references:
ISO 10012 - Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment
Published by ISO on April 15, 2003
This International Standard specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and...
This document references:
ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
This document references:
ISO 11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements
Published by ISO on November 1, 2014
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 references:
ISO 14937 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Published by ISO on October 15, 2009
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a...
This document references:
TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by ISO on November 1, 2021
This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO...
This document references:
ISO/IEC GUIDE 99 - International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
Published by ISO on January 1, 2007
In this Vocabulary, a set of definitions and associated terms is given, in English and French, for a system of basic and general concepts used in metrology, together with concept diagrams to...
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