> iec_82304-1:2016
IEC 82304-1:2016
Health Software — Part 1: General Requirements for Product Safety
IEC 82304-1:2016 addresses standalone health software intended to operate on general computing hardware without dedicated medical hardware. It covers the full product lifecycle: product use requirements, system validation, clinical evaluation, post-market surveillance, and decommissioning, while invoking IEC 62304 for the underlying software development process.
Scope & Applicability
Applies to standalone health software products available to healthcare professionals, patients, or consumers that do not require specialized proprietary hardware.
Non-Coverage Boundaries
Does not apply to software embedded as an integral part of hardware medical devices.
Key Clauses & Control Requirements
Health Software Product Requirements
Specifying clinical indication, target computing platforms, operating systems, and network communication constraints.
Software Product Validation
Validating that the software satisfies intended use and meets all specified user needs in realistic operating environments.
Required Regulatory & Audit Evidence Artifacts
- [✓]Product Requirements Specification (PRS) for Standalone Health Software
- [✓]System Validation Plan and Validation Summary Report
- [✓]Accompanying documents and Instructions for Use (IFU) for consumers and clinicians
“IEC 82304-1 is the missing bridge between generic software engineering and medical device regulation for SaaS and mobile health apps.”
Cross-Surface Ecosystem Relationships
- IEC 82304-1:2016 Health software - Part 1: Product safety ↗(International Electrotechnical Commission)
Frequently Asked Questions
How does IEC 82304-1 relate to IEC 62304?
IEC 82304-1 treats the software as a complete commercial product (including packaging, documentation, and validation), while directing the engineering team to follow IEC 62304 for the software engineering processes.