AAMI TIR 29:2012(R2017)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
English
18-10-2017
01-03-2024
Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Normative reference
3 Terms and definitions
4 Installation qualification
5 Operational Qualification
6 Performance Qualification
7 Product and Process Specifications
8 Routine Monitoring and Control
9 Maintaining Process Effectiveness
10 Assessment of Change
Annexes
Annex A - Measurement uncertainty in
routine monitoring of dose
Annex B - Source distribution equivalency
Annex C (informative) - Bibliography
Gives additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization.
| DocumentType |
Guide
|
| ISBN |
978-1-57020-477-7
|
| Pages |
56
|
| ProductNote |
Reconfirmed 2017
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI ISO 11137-2 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ISO/ASTM 51702:2013 | Practice for dosimetry in a gamma facility for radiation processing |
| 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/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 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/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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