What IEC 82304-1 (Health Software) requires
IEC 82304-1:2016 is the international standard for general health software product safety. It is designed for software products that do not have dedicated hardware and are used in health environments (e.g., lifestyle, wellness, or administrative software), ensuring safety, reliability, and security across the product lifecycle.
Pillar: Medical & Healthcare · Authority: ISO (International Organization for Standardization) · Version: 1.1.1 · Last updated:
Primary source: https://www.iso.org/standard/64951.html
SHA-256 integrity: 1ded65a990e5d1a923470489e0403257e2ec7b0898b87d3e5bf7ecdb35e885ab
Primary Citations — 6 traced to source
- IEC 82304-1:2016 Health software - Part 1: General requirements for product safety
- IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/iec-82304-1-health-software.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/iec-82304-1-health-software.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/iec-82304-1-health-software
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