International Standards and Conformity Assessment for all electrical, electronic and related technologies

News release – 2012 Number 02

ISO/IEC guide upgrades safety aspects in medical device standards

 

Geneva, Switzerland, 2012-02-29 – IEC and ISO (International Organization for Standardization) have just published a new, improved guide to help standards writers address safety aspects in medical device standards even more thoroughly.

 

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ISO/IEC Guide 63, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on and replaces a 1999 edition.

 

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 optimal use of resources by only developing medical device safety standards for which there is a clear market requirement.

 

The guide 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 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 JWG (Joint Working Group) 1: Application of risk management to medical devices.

 

ISO/IEC Guide 63 can be purchased on the IEC Webstore.