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ISO, IEC update safety aspects in medical device standards

ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have just published a new guide to help standards writers address safety aspects in medical device standards more thoroughly than ever. ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, replaces the 1999 edition. Notably, it responds to the risk-based framework set out in ISO 14971: 2007, Medical devices - Application of risk management to medical devices. A global approach among manufacturers, users, regulatory authorities, and other stakeholders is essential to coherent medical-device safety standard development.

As Alfred Dolan, leader of the team that updated the guidelines, explains, “ISO/IEC Guide 63:2012 identifies common elements of all medical device safety standards and recommends a logical order to address these within a risk management framework specified in ISO 14971. It provides a helpful context for developing consistent standards.”

ISO/IEC Guide 63 is for use by all ISO and IEC bodies involved in the development of medical device safety standards. It can also be used by non-ISO and IEC standards development organizations that are writing medical device safety standards or comparable documents. For more information, visit

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