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04/30048584 DC : DRAFT MAY 2004

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE

Published date

23-11-2012

Superseded date

29-06-2007

Superseded by

BS EN ISO 11137-2:2015

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BS EN ISO 11137-2

Committee
CH/198
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO 11137-1:2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
AAMI TIR27 : 1ED 2001 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE - METHOD VD MAX
AAMI ST32 : 1991 GUIDELINE FOR GAMMA RADIATION STERILIZATION
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

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