ISO 14971 (Medical devices – Application of Risk ...（ISO 14971(医疗设备应用程序的风险）.pdfVIP

ISO 14971 May 2014 Page 1 ISO 14971 (Medical devices – Application of Risk Management to Medical Devices) CHANGED? If you ask whether ISO 14971 standard requirements have changed, the answer would be YES and NO. In August 2012, EN ISO 14971:2012 has been released and superseded EN ISO 14971:2009 to support the Directives. The changes are described in Annex ZA, ZB and ZC, the core text of the standard remains unchanged. This is triggered when comp