AAMI ISO 11137-2 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
English
01-01-2013
23-05-2019
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 11137-2:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Definition and maintenance of product families
for dose setting, dose substantiation and
sterilization dose auditing
5 Selection and testing of product for establishing
the sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive
information from incremental dosing to determine
an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Bibliography
Describes methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6].
| Committee |
WG 02
|
| DevelopmentNote |
Supersedes AAMI ISO 11137, AAMI TIR27 and AAMI ISO TIR 13409 (03/2006)
|
| DocumentType |
Standard
|
| Pages |
88
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137-2:2013 | Identical |
A newer version of this standard is available.
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