AAMI TIR14 : 2016
Superseded
View Superseded by
CONTRACT STERILIZATION USING ETHYLENE OXIDE
English
06-05-2016
02-16-2023
Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Definitions
3 Selection of sterilization facility
4 Written agreement between product manufacturer and
contract sterilizer
5 Validation program
6 Handling of BIs, PCDs, and product samples
7 Sterilization processing documentation
8 Controls for routine processing
Bibliography
Gives guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations.
| DevelopmentNote |
Formerly it was AAMI ST27 (05/2001)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-613-9
|
| Pages |
19
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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