How many controls does IEC 60601-1 have?

IEC 60601-1 contains 20 controls organized across 6 domains.

Where does IEC 60601-1 apply?

IEC 60601-1 is applicable in International. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does IEC 60601-1 map to?

IEC 60601-1 has control-to-control mappings with 221 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with IEC 60601-1 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

IEC 60601-1 — Medical Electrical Equipment Safety

IEC 60601-1 is the international standard for the safety and essential performance of medical electrical equipment. It establishes general requirements for basic safety and essential performance applicable to all medical electrical equipment and medical electrical systems.

Domains

Clause 15-17: Construction, ME Systems, and EMC

Clause 11-14: Temperatures, Accuracy, Faults, and PEMS

Clause 8-10: Protection Against Hazards

Clause 6-7: Classification, Identification and Marking

Clause 4-5: General Requirements and Testing

Frequently Asked Questions

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