AAMI TIR40 : 2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - GUIDANCE ON DOSE SETTING UTILIZING A MODIFIED METHOD 2
Hardcopy , PDF
09-04-2024
English
31-01-2018
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Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Normative References
3 Abbreviations, terms, and definitions
4 Modified Method 2 - Application for method
5 Modified Method 2: Dose setting using fraction positive
information from incremental dosing to determine an
extrapolation factor
6 Procedure for Modified Method 2A
7 Procedure for Modified Method 2B
8 Auditing sterilization dose
9 Worked examples
Bibliography
Defines a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a predetermined sterility assurance level (SAL).
| DocumentType |
Standard
|
| ISBN |
978-1-57020-694-8
|
| Pages |
27
|
| 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Superseded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 |
| AAMI ISO TIR 11139 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
| AAMI ST32 : 1991 | GUIDELINE FOR GAMMA RADIATION STERILIZATION |
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