Regulatory Focus™ > News Articles > New ISO/IEC Guide Addresses Medical Device Safety Regulations

New ISO/IEC Guide Addresses Medical Device Safety Regulations

Posted 28 February 2012 | By Alexander Gaffney, RAC 

A new guide put forth by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) aims to address medical device safety by guiding the development of new safety standards.

ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in international standards for medical devices, seeks to improve upon earlier ISO guides by promoting the "optimal use of resources" through limiting the development of new standards to areas where there is a clear need.

"ISO/IEC Guide 63:2012 identifies common elements of all medical device safety standards and recommends a specific logical order to address these within a risk management framework as specified in ISO 14971," said Alfred M. Dolan, head author of the guideline.

"A global approach among manufacturers, users, regulatory authorities and other stakeholders is needed for the planning and development of medical device safety standards," said ISO spokesperson Elizabeth Gasiorowski-Denis in a statement. "To create a coherent approach to the treatment of safety in the preparation of standards, close coordination within and among committees responsible for different medical devices is necessary."

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ISO/IEC guide upgrades safety aspects in medical device standards

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