Standard
IEC 82304-1:2016
Manufacturers of health software placed on the market without dedicated hardware, for general computing platforms.
Publisher metadata and public scope were checked. The full licensed standard was not reviewed; retained clause explanations are practitioner material and require confirmation against an authorized copy and applicable adoption.
Open official sourceDoes this apply to my work?
The health-software scope is not identical to every jurisdiction’s medical-device definition.
Assess applicable adoption and product context.
What does it address?
Health-software product safety across its lifecycle.
What does this mean in practice?
The controls and evidence below are practitioner examples. They are not mandatory document names or a complete list of obligations.
| Source provision | Requirement or recommendation | Practical control or activity | Example evidence | Applicability note |
|---|---|---|---|---|
| Health-software product scope | Standard requirements depend on applicable adoption | Define the supported computing environment and intended product use. | Product scope and evidence for the supported environment. | Confirm detailed requirements in the licensed standard. |
Illustrative example
A decision in practice
- Intended use
- A manufacturer markets health software for general computing platforms.
- Risk
- An unsupported platform might affect a safety-relevant function.
- Control
- Define and communicate supported configurations.
- Testing
- Evaluate the relevant functions on supported environments.
- Evidence
- Configuration boundaries and product verification observations.
- Conclusion
- Product evidence must address the actual intended use and platform limitations.
More practitioner context
Practical impact
Health-software product safety across its lifecycle.
Actions to consider
Confirm product scope and consult an authorized copy.
Practitioner interpretation
The health-software scope is not identical to every jurisdiction’s medical-device definition.
Continuing context
The health-software scope is not identical to every jurisdiction’s medical-device definition.
Source and review information
Source check: 21 September 2026. Publisher metadata and public scope were checked. The full licensed standard was not reviewed; retained clause explanations are practitioner material and require confirmation against an authorized copy and applicable adoption.
Citation, dates and editorial history
- Stable source ID
- iec-82304-1-health-software
- Official citation
- IEC 82304-1:2016 — Health software — Part 1: General requirements for product safety
- Issuing organization
- International Electrotechnical Commission
- Edition
- Edition 1.0 (2016)
- Publication
- 27 October 2016
- Application / transition
- Assess applicable adoption and product context.
- Publication status
- Final / published
- Verification
- Verified — public source metadata and scope
- Editorial update
- 21 September 2026 · Version 2.0
- Source owner
- CSVtoCSA editorial
- Review needed
- Full-text / applicability review as described above
- Independent review
- No independent regulatory review is claimed.
21 September 2026: Source metadata checked, scope clarified, practical mapping and illustrative example added, and layout reorganized. Existing detailed guide content and its dated history are retained below its disclosure. This is an editorial update, not a regulatory amendment.
Questions and corrections
Contributor opinions are moderated and remain distinct from the source and site explanation. Comments do not update source metadata.
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Source: iec-82304-1-health-software
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