10/30208681 DC : DRAFT SEP 2010
Current
Current
The latest, up-to-date edition.
BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
Published date
23-11-2012
Publisher
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BS ISO/IEC GUIDE 63
| Committee |
CH/210/4
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Standards | Relationship |
| ISO/IEC Guide 63:2012 | Identical |
| 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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