BS 82304-1:2017 pdf download – Health Software Part 1: General requirements for product safety 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 :201 5 shall apply to the HEALTH SOFTWARE in addition to the other requirements of this document. IEC 62304:2006 and IEC 62304/AMD1 :201 5 normatively references ISO 1 4971 :2007. It is recognized that the MANUFACTURER might not be able to follow all the process steps identified in ISO 1 4971 :2007 for each constituent component of the HEALTH SOFTWARE , such as proprietary components, subsystems of non-healthcare origin, and legacy software. In this case, the MANUFACTURER shall take account of the RESIDUAL RISKS and implement RISK CONTROLS around those found to be unacceptable. 6 * H EALTH SOFTWARE PRODUCT VALIDATION 6.1 V ALIDATION plan The MANUFACTURER shall establish a VALIDATION plan addressing all HEALTH SOFTWARE PRODUCT use requirements established in 4.2. In the VALIDATION plan, the MANUFACTURER shall: a) identify the VALIDATION scope and the corresponding VALIDATION activities; b) identify the constraints that potentially limit the feasibility of VALIDATION activities; c) select appropriate VALIDATION methods, input information, and associated acceptance criteria for successful VALIDATION ; d) identify the enabling systems or services such as operating environment(s), including hardware and software platforms, needed to support VALIDATION ; e) specify the required qualification of the VALIDATION personnel; where training is required, this shall be completed before starting the VALIDATION ; f) define the appropriate level of independence of the VALIDATION team from the design team. NOTE 1 Constraints include: technical feasibility, cost, time, availability of VALIDATION enablers or qualified personnel, contractual constraints, criticality of the mission, etc. NOTE 2 V ALIDATION methods include: inspection, analysis, analogy/similarity, demonstration, simulation, peerreview, testing or certification. Relevant information: reference to standards and other publications such as compatibility standards, regulatory authority guidance documents, and clinical literature. 6.2 Performing VALIDATION The MANUFACTURER shall confirm readiness for VALIDATION once: a) the VALIDATION plan has been established; b) the VALIDATION team has been set up with the appropriately qualified personnel; and c) as appropriate, development life cycle phases as required by Clause 5 have been completed for those parts of the HEALTH SOFTWARE PRODUCT subject to VALIDATION . The VALIDATION team shall perform the VALIDATION activities in the intended operational environment(s) according to the VALIDATION plan of 6.1 . Where deviations from the...
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