IEC 60601-1 Safety Testing

IEC 60601-1 Edition 3.1 & 3.2 Medical Safety Testing

IEC 60601-1 is the fundamental safety standard for medical electrical equipment worldwide. Compatible Electronics provides comprehensive IEC 60601-1 Edition 3.1 and 3.2 testing as an FDA ASCA recognized laboratory (TL-80).

What is IEC 60601-1?

IEC 60601-1 specifies general requirements for basic safety and essential performance of medical electrical equipment. It addresses hazards including electric shock, mechanical hazards, excessive temperatures, fire, and radiation to protect patients, operators, and the environment.

Means of Protection (MOP) Concept

MOOP

Means of Operator Protection
Single vs. double protection
Risk-based insulation design

MOPP

Means of Patient Protection
Applied part classifications
Enhanced protection requirements

Type B

Non-critical patient contact
Standard leakage limits
Basic protection level

Type BF / CF

BF: Floating applied part
CF: Cardiac floating
Direct heart connection capability

Key Safety Tests

Dielectric strength (hi-pot) testing
Protective earth continuity
Leakage current measurements (earth, touch, patient)
Creepage and clearance verification

Temperature measurements under normal and abnormal conditions
Mechanical strength and stability
Ingress protection (IP rating) verification
Biocompatibility considerations
Abnormal operation and fault conditions

Applied Part Classifications

Type B Applied Parts

Not directly contacting patient or contacting non-critical areas. Standard protection level with basic leakage current limits.

Type BF Applied Parts

Floating applied part with patient connection. Enhanced protection with isolated patient circuitry and reduced leakage requirements.

Type CF Applied Parts

Cardiac floating applied part for direct heart connection. Highest level of protection with the most stringent leakage current limits.

Defibrillation-Proof

Special requirements for devices that may be used during defibrillation. Protection against high-energy discharge effects.

Risk Management Integration

ISO 14971 Integration

Edition 3 introduced ISO 14971 risk management integration. Manufacturers must identify hazardous situations, evaluate risks, and demonstrate that residual risks are acceptable. Our testing supports your risk management documentation.

Risk management is now integral to demonstrating safety compliance