STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Measurement of dose
5 Establishing the maximum acceptable dose
6 Establishing the sterilization dose
7 Installation qualification
8 Operational qualification
9 Performance qualification
10 Routine monitoring and control
Annex A (informative) - Mathematical modelling
Annex B (informative) - Tables of references for
        dosimetry-related testing during IQ/OQ/PQ
Annex C (informative) - Tolerances associated with
        doses used in sterilization dose setting/substantiation
        in ISO 11137-2 and ISO/TS 13004
Annex D (informative) - Application of dose measurement
        uncertainty in setting process target doses
Bibliography

Provides 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.

DevelopmentNote	Supersedes I.S. EN 552. (07/2006)
DocumentType	Standard
Pages	58
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 11137-3:2006

Standards	Relationship
NF EN ISO 11137-3 : 2017	Identical
NEN EN ISO 11137-3 : 2017	Identical
DIN EN ISO 11137-3:2015-08 (Draft)	Identical
NS EN ISO 11137-3 : 2017	Identical
EN ISO 11137-3:2017	Identical
NBN EN ISO 11137-3 : 2006	Identical
UNE-EN ISO 11137-3:2007	Identical
ISO 11137-3:2017	Identical
BS EN ISO 11137-3:2017	Identical
UNI EN ISO 11137-3 : 2006	Identical
SN EN ISO 11137-3 : 2017	Identical

ISO/TS 13004:2013	Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
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/ASTM 51401:2013	Practice for use of a dichromate dosimetry system
ISO/ASTM 51650:2013	Practice for use of a cellulose triacetate dosimetry system
ISO 11462-2:2010	Guidelines for implementation of statistical process control (SPC) — Part 2: Catalogue of tools and techniques
ISO/ASTM 51276:2012	Practice for use of a polymethylmethacrylate dosimetry system
ISO/ASTM 52303:2015	Guide for absorbed-dose mapping in radiation processing facilities
ISO/ASTM 51818:2013	Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
ISO/ASTM 51261:2013	Practice for calibration of routine dosimetry systems for radiation processing
ISO 14253-1:2017	Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO/ASTM 51275:2013	Practice for use of a radiochromic film dosimetry system
ISO/ASTM 51608:2015	Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
ASTM E 2232 : 2016 : REDLINE	Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
ISO/ASTM 52701:2013	Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
ISO/ASTM 51607:2013	Practice for use of the alanine-EPR dosimetry system
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO/ASTM 51649:2015	Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
ISO/ASTM 51707:2015	Guide for estimation of measurement uncertainty in dosimetry for radiation processing
ISO/ASTM 52628:2013	Standard practice for dosimetry in radiation processing
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO/ASTM 51631:2013	Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations

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I.S. EN ISO 11137-3:2017

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