ISO IEC guide upgrades safety aspects in medical device Standards


ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have published a new, improved guide to help Standards writers address safety aspects in medical device Standards even more thoroughly. ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on and replaces a 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.

'ISO/IEC Guide 63 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,' says Alfred M. Dolan, Convenor of the team that updated the guidelines. 'It provides a very helpful context in developing consistent Standards'.

Read more in our March 2012 Touchstone article.

Order ISO/IEC Guide 63:2012 (hard copy) or ISO 14791:2007 (hard copy) from You can order PDFs of ISO and IEC Standards by calling 0800 782 632 during business hours or emailing

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