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Posts Tagged ‘safety aspects’

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.

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.

Global Manager Group is one of the leading global ISO and safety consultants. They offers their consultancy services worldwide in areas of ISO 9001 quality management system, iso 14001 environment management system, ISO/IEC 17025 , iso 22000 food management system, iso 27001 information security management system, brc food safety standard and ohsas 18001 and hse manual for health, safety and Environment management system.


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