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AAMI ISO TIR 15843 : 2000

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PRODUCT FAMILIES AND SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS, AND FREQUENCY OF STERILIZATION DOSE AUDITS

Superseded date

16-01-2007

Published date

23-11-2012

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Gives three approaches that the primary manufacturer can use to reduce the total number of product units tested to establish and audit the radiation sterilization dose while maintaining assurance that the designated sterility assurance level (SAL) is achieved.

Committee
WG 02
DevelopmentNote
To be used in conjunction with AAMI ISO 11137 (07/2002) Supersedes AAMI ST31, AAMI ST32 and AAMI TIR5. (04/2004)
DocumentType
Standard
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO/TS 15843:2000 Identical

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