Standards Database
Comprehensive database of medical device standards with implementation guidance
ISO 13485
Medical devices — Quality management systems
Quality management system requirements for medical device manufacturers
ISO 14971
Medical devices — Application of risk management
Risk management process for medical devices throughout the lifecycle
IEC 62304
Medical device software — Software life cycle processes
Software development lifecycle requirements for medical device software
IEC 60601-1
Medical electrical equipment — Part 1: General requirements
General safety and essential performance requirements for medical electrical equipment
IEC 60601-1-2
Medical electrical equipment — Part 1-2: Electromagnetic disturbances
EMC requirements and testing for medical electrical equipment
IEC 62366
Medical devices — Application of usability engineering
Usability engineering process for medical devices
IEC 60601-2-22
Medical electrical equipment — Part 2-22: Laser equipment
Particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1
Safety of laser products — Part 1: Equipment classification
Laser product classification and safety requirements
ISO 10993
Biological evaluation of medical devices
Biological safety evaluation and biocompatibility testing requirements for medical devices
ISO 14155
Clinical investigation of medical devices for human subjects
Good clinical practice for clinical investigations of medical devices
IEC 81001-5-1
Health software and health IT systems safety, effectiveness and security
Cybersecurity requirements for health software and IT systems
ISO 15223
Medical devices — Symbols to be used with medical device labels
Standardized symbols for medical device labeling and information
ISO 20417
Medical devices — Information to be supplied by the manufacturer
Requirements for information supplied with medical devices including labeling
IEC 60601-2-57
Medical electrical equipment — Part 2-57: Particular requirements for basic safety and essential performance of non-laser light source equipment
Safety requirements for LED and other non-laser light source medical equipment
Phase 1: Standards Database - In Development
We're building comprehensive standard pages with implementation guidance, visual diagrams, and medical laser system examples. Content will be published as it's completed.