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SNV - SN EN ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

active
Organization: SNV
Publication Date: 1 December 2015
Status: active
Page Count: 84
ICS Code (Sterilization and disinfection in general): 11.080.01
ICS Code (Other standards related to sterilization and disinfection): 11.080.99

Document History

SN EN ISO 11137-2/A1
April 1, 2023
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment A1
A description is not available for this item.
SN EN ISO 11137-2
December 1, 2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
A description is not available for this item.
SN EN ISO 11137-2
August 1, 2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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...
SN EN ISO 11137-2
June 1, 2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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...
SN EN ISO 11137-2
September 1, 2009
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Corrigendum AC
A description is not available for this item.
SN EN ISO 11137-2
June 1, 2006
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
A description is not available for this item.
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References

This document references:
ISO 11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
Published by ISO on June 1, 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...
This document references:
ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
Published by ISO on January 1, 2018
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw...
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 11137-1 - 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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