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.
A global approach among manufacturers, users, regulatory authorities and other stakeholders is needed for the planning and development of medical device safety standards. 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.
ISO/IEC Guide 63 is designed to improve the interface between the standards-developing committees and the stakeholders they serve, as well as to make the optimal use of resources by only developing medical device safety standards for which there is a clear market requirement.
Alfred M. Dolan, Convenor of the team that updated the guidelines, described the benefits which the new guide is expected to bring to users and the improvements made compared to the 1999 edition it replaces:
“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. It provides a very helpful context in developing consistent standards.
“Compared to the 1999 version, the new guide accentuates the concept of risk and emphasizes the need to consider the relationship between hazards and the associated harms which may result. The resultant risk is what standards need to control through establishing technical or process requirements in those standards.”
ISO/IEC Guide 63 is intended to be used 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 at the international, regional or national levels that are considering or are in the process of developing medical device safety standards and/or comparable documents.
For Dr. Eamonn Hoxey, Chair of ISO/TC 210, Quality management and corresponding general aspects for medical devices, the new guide will provide precise recommendations across all medical device standards. “ISO/IEC Guide 63:2012 will provide a harmonized approach to the concept of safety when developing medical device safety standards. In this way it will help manufacturers and users to collaborate effectively to ensure the safety and performance of medical devices used in health facilities worldwide.”
ISO/IEC Guide 63 was prepared jointly by ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice, in a Joint Working Group, Application of risk management to medical devices. It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 108 Swiss francs respectively through the ISO Store or by contacting the Marketing, Communication & Information department.