Medical Devices

www.iso.ch/iso/en
ISO also offers three documents related to medical devices: ISO 13485:2003, a standard covering quality management system requirement for regulatory purposes; ISO/TR 14969:2004, which provides guidance of applying ISO 13485; and Guide 63:1999 on inclusion of safety aspects in standards for medical devices. ISO’s search engine can be used to find information on each of these documents.

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