AAMI ISO TIR 13409 : 1996 ERRATA 2005
Superseded
Superseded
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES
Published date
11-23-2012
Superseded date
05-30-2006
Superseded by
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Summarise this standard
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Describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1,000 colony forming units (cfu) that are manufactured in small quantities (less than 1,000 product units).
| Committee |
WG 02
|
| DevelopmentNote |
Together with AAMI ISO 11137, supersedes AAMI ST32. (04/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO/TS 13409:2002 | Identical |
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