DIN EN ISO 11137-3:2017
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

Standard No.

DIN EN ISO 11137-3:2017

Release Date

2017

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 11137-3:2017-11

Latest

DIN EN ISO 11137-3:2017-11

Replace

DIN EN ISO 11137-3:2006 DIN EN ISO 11137-3:2015

Scope

ISO 11137-3 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.

DIN EN ISO 11137-3:2017 Referenced Document

• ASTM E2232-16 Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
• DIN CEN ISO/TS 13004:2014 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014
• DIN EN ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003
• DIN EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013); German version EN ISO 11137-1:2015
• DIN EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015
• DIN EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
• DIN EN ISO 14253-1:2013 Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformity or nonconformity with specifications (ISO 14253-1:2013); German version EN ISO 14253-1:2013
• DIN EN ISO 14253-2:2011 Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 2: Guidance for the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification (ISO 1425
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005
• ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO 11462-2:2010 Guidelines for implementation of statistical process control (SPC) - Part 2: Catalogue of tools and techniques
• ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14253-1:2013 Geometrical product specifications (GPS).Inspection by measurement of workpieces and measuring equipment.Part 1: Decision rules for proving conformity or nonconformity with specifications
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO/ASTM 51205:2017 Practice for use of a ceric-cerous sulfate dosimetry system
• ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
• ISO/ASTM 51275:2013 Practice for use of a radiochromic film dosimetry system
• ISO/ASTM 51276:2012 Practice for use of a polymethylmethacrylate dosimetry system
• ISO/ASTM 51401:2013 Practice for use of a dichromate dosimetry system
• ISO/ASTM 51538:2009 Practice for use of the ethanol-chlorobenzene dosimetry system
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• ISO/TS 13004:2013 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>

DIN EN ISO 11137-3:2017 history

• 2017 DIN EN ISO 11137-3:2017-11 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
• 2017 DIN EN ISO 11137-3:2017 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
• 2006 DIN EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) English version of DIN EN ISO 11137-3:2006-07
• 0000 DIN EN ISO 11137-3:2004
• 1970 DIN EN 552:2001