The MANUFACTURER shall establish a VALIDATION plan addressing all HEALTH SOFTWARE PRODUCT use requirements established in 4.2. In this case, the MANUFACTURER shall take account of the RESIDUAL RISKS and implement RISK CONTROLS around those found to be unacceptable. It is recognized that the MANUFACTURER might not be able to follow all the process steps identified in ISO 14971:2007 for each constituent component of the HEALTH SOFTWARE, such as proprietary components, subsystems of non-healthcare origin, and legacy software. The requirements in 4.2, 4.3, Clause 5, Clause 6, Clause 7, Clause 8 and Clause 9 of IEC 62304:2006 and IEC 62304/AMD1:2015 shall apply to the HEALTH SOFTWARE in addition to the other requirements of this document. The system requirements for the HEALTH SOFTWARE PRODUCT established in 4.5 shall be used as primary design input for the life cycle process of the HEALTH SOFTWARE PRODUCT. The second edition of ISO 24971 was published in 2020 and contains some of the informative annexes from the second edition of ISO 14971.IEC 82304-1 pdf free download.Health software- Part 1: General requirements for product safety.ĥ * HEALTH SOFTWARE - Software life cycle processes In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard. The Annex ZB harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/746) of 2017. The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017. The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998.
The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990. 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.
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