BS IEC 82304-1:2016 pdf download.Health software
I Scope
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 “medical 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 does not apply to HEALTH SOFTWARE which is intended to become part of a specific hardware designed for health use. Specifically, IEC 82304-1 does not apply to:
a) medical electrical equipment or systems covered by the IEC 6060 1/IEC 80601 series;
b) in vitro diagnostic equipment covered by the IEC 61010 series; or
c) implantable devices covered by the ISO 14708 series.
NOTE This document also applies to HEALTH SOFTWARE PRODUCTS (e.g. medical apps. health apps) intended to be
used in combination with mobile computing platforms.
1.3 Compliance
Compliance with this document is determined by inspection of all documentation required by this document.
Assessment of compliance is carried out and documented by the MANUFACTURER. Where the HEALTH SOFTWARE PRODUCT is subject to regulatory requirements, external assessment may take place.
Where this document normatively references parts or clauses of other standards focused on SAFETY or SECURITY, the MANUFACTURER may use alternative methods to demonstrate compliance with the requirements of this document. These alternative methods may be used if the process results of such alternative methods, including traceability, are demonstrably equivalent and the RESIDUAL RISK remains acceptable.
NOTE The term conformance is used in ISOIIEC 12207 where the term “complianc&’ is used in this document.
3.8 INTENDED USE
INTENDED PURPOSE
use for which a product, process or service is intended according to the specifications,instructions and information provided by the MANUFACTURER[SOURCE: ISO 14971:2007, 2.5]
3.9 IT-NETWORK
INFORMATION TECHNOLOGY NETWORK
a system or systems composed of communicating nodes and transmission links to provide physically linked or wireless transmission between two or more specified communication nodes
Note 1 to entry: The scope of the IT-NETWORK in this document is defined by the RESPONSIBLE ORGANIZATION based on where the HEALTH SOFTWARE in the IT-NETWORK is located and the defined use of the IT-NETWORK. It can contain IT infrastructure, home health, or general computing components or systems not intended by design to be used in a healthcare setting. See also 7.2.3.2.[SOURCE: IEC 61907:2009, 3.1.1, modified - The definition has been rephrased and Note 1 to entry has been added.].BS IEC 82304-1 pdf download.