![]() ![]() ![]() The Annex ZA harmonized ISO 14971:2012 with the Medical Devices Directive 93/42/EEC of 1993. ISO 14971:2012 was harmonized with respect to the three European Directives associated with medical devices through the three 'Zed' Annexes (ZA, ZB & ZC). Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production. The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971. This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard for the application of risk management to medical devices. ![]()
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