AAMI ISO 11137 : 94 AMD 1 2002
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
Superseded date
30-05-2006
Published date
23-11-2012
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Provides requirements for validation, process control and routine monitoring for radiation sterilization of health care products.
| Committee |
WG 02
|
| DevelopmentNote |
Together with AAMI ISO TIR 13409, supersedes AAMI ST32. Supersedes AAMI ST31 and AAMI TIR5. (07/2002)
|
| DocumentType |
Standard
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137:1995 | Identical |
| AAMI AT6 : 2013 | AUTOLOGOUS TRANSFUSION DEVICES |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
| ASTM F 2051 : 2000 : R2014 | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| ASTM F 2051 : 2000 | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| AAMI ISO TIR 13409 : 1996 ERRATA 2005 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES |
| ASTM F 2051 : 2000 : R2006 | Standard Specification for Implantable Saline Filled Breast Prosthesis |
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