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CSA Z11137-3 : 2007 : R2012 : FR

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
Available format(s)

Hardcopy , PDF

Superseded date

01-08-2017

Published date

01-01-2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Measurement of dose
5 Selection and calibration of dosimetry systems
6 Establishing the maximum acceptable dose
7 Establishing the sterilization dose
8 Installation qualification
9 Operational qualification
10 Performance qualification
11 Routine monitoring and control
Annex A (informative) - Mathematical modelling
Bibliography

Provides guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry.

DevelopmentNote
Supersedes CSA ISO 11137. (01/2009)
DocumentType
Standard
Pages
36
ProductNote
Reconfirmed F
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11137-3:2017 Identical

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/ASTM 51276:2012 Practice for use of a polymethylmethacrylate dosimetry system
ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
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 51607:2013 Practice for use of the alanine-EPR dosimetry system
ISO 9001:2015 Quality management systems — Requirements
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
ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
ISO/ASTM 51631:2013 Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations

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