What IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes for Safety Classification requires
This international standard defines the life cycle requirements for medical device software, mandating a risk-based approach where all software is assigned a safety class (A, B, or C) based on its potential to cause harm (Clause 4.3). This classification dictates the rigor of the required software development, risk management, and maintenance processes.
Pillar: Medical & Healthcare · Authority: International Electrotechnical Commission (IEC) · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/38421.html
SHA-256 integrity: c20c275d2a2e508e17083c5eaf94161c136656402db34700e1f23421c5843328
Primary Citations — 6 traced to source
- IEC 62304:2006+A1:2015, Clause 4.3 - Software safety classification
- IEC 62304:2006+A1:2015, Clause 5.1 - Software development planning
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