Comment Closes On
|
|
Committee
|
CH/198 |
Document Type
|
Draft |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
British Standards Institution
|
Status
|
Superseded |
Superseded By
|
|
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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