IEC 82304-1:2016,Health software – Part 1: General requirements for product safety.
HEALTH SOFTWARE PRODUCTS, within the context of this document, are software-only products. These products are intended to be used with computing equipment not explicitly developed for running the software. HEALTH SOFTWARE PRODUCTS may require specified platforms.
HEALTH SOFTWARE PRODUCTS are intended by their MANUFACTURER for managing, maintaining or improving health of individual persons, or the delivery of care. Some HEALTH SOFTWARE can contribute to a HAZARDOUS SITUATION. Accordingly, Clause 5 requires a RISK MANAGEMENT process for all HEALTH SOFTWARE. For HEALTH SOFTWARE that can contribute to a HAZARDOUS SITUATION, RISK CONTROL is needed to prevent HARM or reduce the likelihood of HARM occurring. Testing of the finished product is not, by itself, adequate to address the SAFETY of HEALTH SOFTWARE. Therefore, requirements for the processes by which the HEALTH SOFTWARE is developed are necessary. This document relies heavily on IEC 62304:2006 and IEC 62304:2006/AMD1:2015 for the software development process which can be applied to
HEALTH SOFTWARE PRODUCTS.
Whether a HEALTH SOFTWARE PRODUCT has to meet regulatory requirements is a matter of national legislation. This document makes no attempt to determine whether a HEALTH SOFTWARE PRODUCT is or should be regulated.
This document aims to provide requirements for the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS; it can only provide such requirements for software-only products. Situations where HEALTH SOFTWARE is a part of—or embedded in— a physical device are outside the scope of this document as these combined products are considered separately in, for example, IEC 60601-1 and associated collateral and particular standards.
This document understands health in a meaning similar to the WHO definition: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” (WHO, 1946). This definition appears not highly suitable for practical purposes: “a state of complete well-being” or the inclusion of social well-being could be interpreted more widely than seems reasonable. For example dating software, games, or flight simulator software could be considered within the scope of the standard. That is clearly not the intent. However, a precise definition — or even delineation — of “health” for practical use in
“HEALTH SOFTWARE” is not available.
HEALTH SOFTWARE refers to software that contributes to the health of individual people as observed and/or demonstrated using measurable health parameters or clinical expertise. This is a subset of “health” as defined by the WHO. The requirements of the standard apply to the software that impacts such health parameters, and/or to software where SECURITY violations would undermine privacy or confidentiality of health and wellbeing information.
1.1 Purpose
This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS.
1.2 Field of application
This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS.
In each referenced standard, the term umedical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.
Where the term “patient” is used, either in this document or in a referenced standard, it refers to the person for whose health benefit the HEALTH SOFTWARE is used.IEC 82304-1:2016 pdf free download.