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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 11137-3:2017); German version EN ISO 11137-3:2017

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Organization: DIN
Publication Date: 1 November 2017
Status: active
Page Count: 55
ICS Code (Sterilization and disinfection in general): 11.080.01
ICS Code (Other standards related to sterilization and disinfection): 11.080.99
scope:

Dieses Dokument gibt eine Anleitung zur Erfüllung der Anforderungen von ISO 11137-1 und ISO 11137-2 und ISO/TS 13004 hinsichtlich der Dosimetrie und ihrem Gebrauch bei der Entwicklung, Validierung und Lenkung der Anwendung eines Strahlensterilisationsverfahrens.

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); German version EN ISO 11137-3:2017
Dieses Dokument gibt eine Anleitung zur Erfüllung der Anforderungen von ISO 11137-1 und ISO 11137-2 und ISO/TS 13004 hinsichtlich der Dosimetrie und ihrem Gebrauch bei der Entwicklung, Validierung...
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); German version EN ISO 11137-3:2006
A description is not available for this item.
DIN EN ISO 11137-3
July 1, 2004
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO/DIS 11137-3:2004); German version prEN ISO 11137-3:2004
A description is not available for this item.

References

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, 2016
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:
ASTM ISO/ASTM 52628 - Standard Practice for Dosimetry in Radiation Processing
Published by ASTM on September 1, 2019
This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance on...
This document references:
ASTM ISO/ASTM 52701 - Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing
Published by ASTM on July 20, 2013
This guide provides guidance on determining the performance characteristics of dosimeters and dosimetry systems used in radiation processing. This guide describes the influence quantities that might...
This document references:
DIN CEN ISO/TS 13004 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014
Published by DIN on October 1, 2014
Einschlussklauseln Diese Technische Spezifikation beschreibt ein Verfahren zur Bestätigung einer ausgewählten Sterilisationsdosis von (17,5; 20; 22,5; 27,5; 30; 32,5 oder 35) kGy, bei der ein...
This document references:
DIN EN ISO 10012 - Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003
Published by DIN on March 1, 2004
A description is not available for this item.
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