ISO/IEC Guide 63:2012 upgrades safety aspects for Medical Devices
ISO (International Organization for Standardization) and IEC (International Electro technical Commission) have just published a new guide ISO/IEC 63:2012 with improved safety aspects in medical devices and instruments.
- Chico, CA (1888PressRelease) March 01, 2012 - As per ISO latest press release on 28th Feb 2012, 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. It will 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 is prepared 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. 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.
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.
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Source: iso.org
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