IEC 82304-1-2016 pdf download.Health software Part 1: General requirements for product safety.
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 60601 /IEC 80601 series;
b) in vitro diagnostic equipment covered by the IEC 61 01 0 series; or
c) implantable devices covered by the ISO 1 4708 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 ISO/IEC 1 2207 where the term “compliance” is used in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 62304:2006, Medical device software – Software life cycle processes
IEC 62304:2006/AMD1 :201 5
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1 ACCOMPANYING DOCUMENT
document accompanying HEALTH SOFTWARE containing information for the RESPONSIBLE ORGANIZATION or USER , particularly regarding SAFETY and/or SECURITY
[SOURCE: IEC 60601 -1 :2005, 3.4, modified – Replace ” ME EQUIPMENT , ME SYSTEM , equipment and accessory” by ” HEALTH SOFTWARE ” and replace ” OPERATOR ” by ” USER ” and added “and/or SECURITY ”.]
3.2 ANOMALY
any condition that deviates from the expected based on requirements specifications, design documents, standards, etc. or from someone’s perceptions or experiences.IEC 82304-1 pdf download.