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.
6.1 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 VALIDATION plan are deemed necessary, they shall be justified in the VALIDATION report. When ANOMALIES are found in the HEALTH SOFTWARE PRODUCT during VALIDATION , these shall be resolved through a problem resolution process according to Clause 9 of IEC 62304/AMD1 :201 5. Where this problem resolution process results in modification of the HEALTH SOFTWARE PRODUCT , the affected part of the VALIDATION shall be repeated, taking into account the extent of the modification.
6.3 V ALIDATION report
The VALIDATION team shall develop the VALIDATION report for the HEALTH SOFTWARE PRODUCT subject to VALIDATION . The VALIDATION report shall provide evidence that:
a) the VALIDATION results are traceable to the HEALTH SOFTWARE PRODUCT use requirements, taken as input;
b) the HEALTH SOFTWARE PRODUCT meets the use requirements established in 4.2; and
c) the RESIDUAL RISK of the HEALTH SOFTWARE PRODUCT remains acceptable. The VALIDATION report shall document the VALIDATION conditions and the results of the VALIDATION activities. If, during VALIDATION , ANOMALIES were identified in the HEALTH SOFTWARE PRODUCT , these shall be listed in the VALIDATION report. The VALIDATION report shall list the members of the VALIDATION team (name, affiliation, function). The VALIDATION report shall include a summary of the VALIDATION results, and the conclusion that the HEALTH SOFTWARE PRODUCT is validated for the INTENDED USE , based on the use requirements.
7.1 * Identification A HEALTH SOFTWARE PRODUCT shall be identified with the name or trademark of the MANUFACTURER , a product name, or type reference, and a unique version identifier such as a revision level or date of release/issue.BS 82304-1 pdf download.