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DIN EN ISO 11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)

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Organization: DIN
Publication Date: 1 July 2006
Status: inactive
Page Count: 24
ICS Code (Other standards related to sterilization and disinfection): 11.080.99
ICS Code (Radiation measurements): 17.240

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 15798 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
Published by DIN on February 1, 2018
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during...
This document is referenced by:
DIN EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023) (includes Amendment A1:2023)
Published by DIN on February 1, 2024
A description is not available for this item.
This document is referenced by:
DIN EN ISO 11070 - Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018) (includes Amendment :2018)
Published by DIN on April 1, 2019
A description is not available for this item.
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 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 5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
Published by DIN on June 1, 2013
This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate...
This document is referenced by:
DIN EN ISO 1135-3 - Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
Published by DIN on May 1, 2017
This part of ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized...
This document is referenced by:
DIN EN ISO 7198 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
Published by DIN on July 1, 2017
This International Standard specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the...
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