AAMI ISO TIR 13409 : 1996 ERRATA 2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES
30-05-2006
23-11-2012
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Superseded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 |
| ASTM F 2038 : 2000 : EDT 1 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| ASTM F 2042 : 2000 : R2005 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| ASTM F 2038 : 2000 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| ASTM F 2042 : 2000 : EDT 1 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| ASTM F 2042 : 2000 : R2011 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
| ASTM F 2038 : 2000 : R2005 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| ASTM F 2038 : 2000 : R2011 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials |
| ASTM F 2042 : 2000 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| AAMI ISO 11137 : 94 AMD 1 2002 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION |
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