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BS EN ISO 11137-3:2017

Current
Current

The latest, up-to-date edition.

Sterilization of health care products. Radiation Guidance on dosimetric aspects of development, validation and routine control
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-23-2017

Publisher

British Standards Institution

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.

This document gives guidance on meeting the requirements in ISO11137‑1 and ISO11137‑2 and in ISO/TS13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

Committee
CH/198
DevelopmentNote
Supersedes 04/30081279 DC. (03/2007) Together with BS EN ISO 11137-1 and BS EN ISO 11137-2, it supersedes BS EN 552. (06/2007) Supersedes 15/30282559 DC. (09/2017)
DocumentType
Standard
Pages
52
PublisherName
British Standards Institution
Status
Current
Supersedes

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 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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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Hardcopy - English
PDF - English
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