CSA Z11137-3 : 2007 : R2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
Hardcopy , PDF
08-01-2017
English
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 |
34
|
| ProductNote |
Reconfirmed EN
|
| 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Superseded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 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 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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