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DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018) (includes Amendment A2:2019)

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Organization: DIN
Publication Date: 1 April 2020
Status: active
Page Count: 63
ICS Code (Other standards related to sterilization and disinfection): 11.080.99

Document History

DIN EN ISO 11137-1
May 1, 2023
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
A description is not available for this item.
DIN EN ISO 11137-1
April 1, 2020
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018) (includes Amendment A2:2019)
A description is not available for this item.
DIN EN ISO 11137-1/A2
October 1, 2017
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/DAM 2:2017); German and English version prEN ISO 11137-1:2015/prA2:2017
A description is not available for this item.
DIN EN ISO 11137-1
November 1, 2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of...
DIN EN ISO 11137-1
December 1, 2013
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013) (includes Amendment A1:2013)
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of...
DIN EN ISO 11137-1
July 1, 2006
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
A description is not available for this item.
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References

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 14001 - Environmental management systems — Requirements with guidance for use
Published by ISO on September 15, 2015
This International Standard specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. This International Standard is...
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 9001 - Quality management systems — Requirements
Published by ISO on September 15, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
This document references:
ISO 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Published by ISO on June 1, 2013
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the...
This document references:
ISO 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
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