ANSI/AAMI/ISO TIR13004:2013(R2016)
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]
Hardcopy , PDF
English
22-08-2016
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Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TS 13004:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families for
sterilization dose substantiation and sterilization
dose auditing
5 Selection and testing of product for substantiating
and auditing a selected sterilization dose
6 Method VD[max][SD] - Substantiation of a selected
sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5,
or 35 kGy
7 Maintaining process effectiveness
8 Tables of values for SIP equal to 1.0 VD[max][SD], SIP
dose reduction factor and augmentation dose
corresponding to applicable values of average bioburden
for selected sterilization doses of 17.5, 20, 22.5, 27.5,
30, 32.5 and 35 kGy
9 Worked examples
Bibliography
Specifies a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes AAMI TIR33. (11/2017)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-504-3
|
| Pages |
85
|
| ProductNote |
Reconfirmed 2016
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO/TS 13004:2013 | Identical |
| 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 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
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