Name: AAMI ISO 11137 : 94 AMD 1 2002
Brand: AAMI

STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION

Superseded date

05-30-2006

Published date

11-23-2012

Publisher

Association for the Advancement of Medical Instrumentation

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Status	Superseded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	AAMI ISO 11137-1:2006 AAMI ISO 11137-2 : 2013 AAMI ISO 11137-3 : 2006
Supersedes	AAMI ST31 : 1990 AAMI ST32 : 1991

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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