AAMI ISO TIR 13409 : 1996 ERRATA 2005

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES

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Superseded date: 30-05-2006

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Published date: 23-11-2012

Publisher: Association for the Advancement of Medical Instrumentation

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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).

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Committee	WG 02
Development Note	Together with AAMI ISO 11137, supersedes AAMI ST32. (04/2004)
Document Type	Standard
ISBN
Pages
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	AAMI ISO 11137-2 : 2013
Supersedes	AAMI ST32 : 1991

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO/TS 13409:2002	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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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