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BSI - BS EN ISO 11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

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Organization: BSI
Publication Date: 30 March 2007
Status: inactive
Page Count: 28
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 11137-3
August 31, 2017
Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
A description is not available for this item.
BS EN ISO 11137-3
March 30, 2007
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
A description is not available for this item.

References

This document references:
BS EN ISO 11137-2 - Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose
Published by BSI on June 30, 2015
A description is not available for this item.
This document references:
AAMI TIR29 - Guide for process characterization and control in radiation sterilization of medical devices
Published by AAMI on January 1, 2012
This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control...
This document references:
90/385/EEC CORR - COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
Published by EU on July 1, 2009
A description is not available for this item.
This document references:
ASTM E2232 - Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
Published by ASTM on December 1, 2020
This guide describes different mathematical methods that may be used to calculate absorbed dose and criteria for their selection. Absorbed-dose calculations can determine the effectiveness of the...
This document references:
BS EN ISO 11137-2 - Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose
Published by BSI on June 30, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 10451 - Dentistry - Contents of technical file for dental implant systems
Published by BSI on July 31, 2010
A description is not available for this item.
This document is referenced by:
BS ISO 14470 - Food irradiation - Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
Published by BSI on January 31, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 16061 - Instruments for use in association with non-active surgical implants — General requirements
Published by BSI on April 30, 2021
A description is not available for this item.
This document is referenced by:
BS EN ISO 11737-1 + A1 - Sterilization of health care products - Microbiological methods Part 1: Determination of a population of microorganisms on products
Published by BSI on February 28, 2018
A description is not available for this item.
This document is referenced by:
BS 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
Published by BSI on July 31, 2015
A description is not available for this item.
This document is referenced by:
BS 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
Published by BSI on July 31, 2015
A description is not available for this item.
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