ISO 11137-3:2017

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

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Referenced standards

ASTM E2232-16ISO 10012:2003ISO 11137-1:2006ISO 11137-2:2013ISO 11462-2:2010ISO 13485:2016ISO 14253-1:2013ISO 14971:2007ISO/ASTM 51205:2017ISO/ASTM 51261:2013ISO/ASTM 51275:2013ISO/ASTM 51276:2012ISO/ASTM 51401:2013ISO/ASTM 51538:2009ISO/ASTM 51607:2013ISO/ASTM 51608:2015ISO/ASTM 51631:2013ISO/ASTM 51649:2015ISO/ASTM 51650:2013ISO/ASTM 51707:2015ISO/ASTM 51818:2013ISO/ASTM 52303:2015ISO/ASTM 52628:2013ISO/ASTM 52701:2013ISO/IEC 17025:2005ISO/TS 13004:2013
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ISO 11137-3:2017

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

ISO 11137-3:2017 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 radiation sterilization process.

Edition2017
Standard Part No3
Published Date2017
Published ByInternational Standardization Organisation
Page Count41