IEC 60601-1 Medical Device Safety & Compliance Testing
IEC 60601-1 specifies general requirements for basic safety and essential performance of medical electrical equipment. Compatible Electronics provides comprehensive medical device safety testing to support regulatory compliance worldwide.
What is IEC 60601-1?
IEC 60601-1 applies to the basic safety and essential performance of medical electrical equipment (ME equipment) and medical electrical systems (ME systems). It serves as the foundation for particular standards covering specific types of medical devices and addresses safety requirements for equipment used in diagnosis, treatment, or monitoring of patients.
Equipment Covered
- Diagnostic imaging equipment
- Patient monitoring systems
- Therapeutic equipment
- Surgical instruments
- Laboratory diagnostic equipment
- Dental equipment
- Physiotherapy equipment
- Infusion pumps and devices
- Defibrillators and cardiac equipment
Key Safety Requirements
- Basic safety requirements
- Essential performance criteria
- Risk management (ISO 14971)
- Applied part classifications
- Means of protection (MOP)
- Electrical safety requirements
- Mechanical safety requirements
- Programmable electrical medical systems (PEMS)
- Usability engineering (IEC 62366)
Tests Performed
- Protective earth continuity
- Earth leakage current
- Patient leakage current
- Dielectric strength testing
- Applied part testing
- Temperature limits testing
- Mechanical strength testing
- Risk management documentation review
Standards We Test To
International
- IEC 60601-1 Ed. 3.1 (2012)
- IEC 60601-1 Ed. 3.2 (2020)
European
- EN 60601-1 (harmonized)
- EN IEC 60601-1:2006/A1:2013
North America
- ANSI/AAMI ES60601-1
- CAN/CSA-C22.2 No. 60601-1
Related Directives and Standards
EU Medical Device Regulation (MDR) 2017/745
EU IVD Regulation (IVDR) 2017/746
FDA 21 CFR Part 820
IEC 60601-1-2 EMC for medical devices
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