BS 10/30208681 DC

BS ISO/IEC Guide 63. Guide to the development and inclusion of safety aspects in International Standards for medical devices British Standards Institution / 13-Sep-2010 / 30 pages

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Cross References:
ISO 5840:2005
ISO 9000:2005
ISO 10993
ISO 10993-17
ISO 11135-1
ISO 11137-1
ISO 13485:2003
ISO 14971:2007
ISO/IEC Guide 51:1999
IEC 62366:2007
ISO/IEC Directives Part 2:2004

All current amendments available at time of purchase are included with the purchase of this document.

Keywords: Standards; Documents; Design; Numerical designations; Standardization; Technical documents; Technical writing; Safety; Safety measures; Packaging; Instructions for use; Medical equipment

Product Code(s): 30208681,30208681

This product references:ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
ISO 14971:2007 - Medical devices - Application of risk management to medical devices
ISO/IEC Guide 51:1999 - Safety aspects -- Guidelines for their inclusion in standards
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 5840:2005 - Cardiovascular implants - Cardiac valve prostheses