Comment Closes On
|
|
Committee
|
CH/210/4 |
Document Type
|
Draft |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
British Standards Institution
|
Status
|
Current |
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 5840:2005
|
Cardiovascular implants Cardiac valve prostheses |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
IEC 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices |
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO/IEC Guide 51:2014
|
Safety aspects Guidelines for their inclusion in standards |
ISO 10993-17:2002
|
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
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