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17/30302489 DC : DRAFT MAR 2017

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION

Superseded date

10-04-2018

Superseded by

BS EN ISO 13408-2:2011

Published date

10-04-2017

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BS EN ISO 13408-2.

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Superseded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 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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