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DIN EN ISO 11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015

inactive
Organization: DIN
Publication Date: 1 August 2015
Status: inactive
Page Count: 94
ICS Code (Other standards related to sterilization and disinfection): 11.080.99

Document History

DIN EN ISO 11137-3
November 1, 2017
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a...
DIN EN ISO 11137-3
August 1, 2015
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015
A description is not available for this item.
DIN EN ISO 11137-3
July 1, 2006
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
A description is not available for this item.

References

This document is referenced by:
DIN EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Published by DIN on August 1, 2015
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document is referenced by:
DIN EN ISO 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Published by DIN on November 1, 2015
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 is referenced by:
DIN EN ISO 13408-1 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
Published by DIN on December 1, 2015
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...
This document is referenced by:
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)
Published by DIN on April 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN ISO 5840-1 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
Published by DIN on May 1, 2021
A description is not available for this item.
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