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AAMI TIR 29:2012(R2017)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

03-01-2024

Language(s)

English

Published date

10-18-2017

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Superseded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
ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
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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