IEC 82304-1 pdf free download
IEC 82304-1 pdf free download.Health software- Part 1: General requirements for product safety.
5 * HEALTH SOFTWARE — Software life cycle processes
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 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.
IEC 62304:2006 and IEC 62304/AMD1:2015 normatively references ISO 14971:2007. 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. In this case, the MANUFACTURER shall take account of the RESIDUAL RISKS and implement RISK CONTROLS around those found to be unacceptable.
6 * HEALTH SOFTWARE PRODUCT VALIDATION
6.1 VALIDATION 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 I Constraints include: technical feasibility, cost, time, availability of VALIDATION enablers or qualified personnel, contractual constraints, criticality of the mission, etc.
NOTE 2 VALIDATION methods include: inspection, analysis. analogylsimilarity, demonstration, simulation, peer- review, 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/AMD1:2015. 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 VALIDATION 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).IEC 82304-1 pdf download.
