ISO/IEC Guide 63:2012 - Safety Aspects in International Standards for Medical Devices

Sidney Vianna

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http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=50729

ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.

ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
 
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Marcelo

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Re: ISO/IEC Guide 63:2012 - Safety Aspects in International Standards for Medical Dev

Great to know that it has been finally published. As the name implies, it's a guide to write standards for medical devices. It's focus is on using ISO 14971 as a framework to create standards (products of process) for dealing with safety of medical devices (something like the new IEC 60601 which requires that the standard is included in a risk management framework.
 
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