TS EN IEC 60601-1 Medical Electrical Equipment Safety Testing

Under this standard, the electrical, mechanical, thermal, and fire hazards that medical electrical equipment may pose to patients, users, and the surrounding environment are evaluated under normal operating conditions, Single Fault Condition (SFC), and reasonably foreseeable abnormal use conditions.

The main product groups that can be evaluated within this scope include:

• Patient monitoring systems
• Medical power supplies
• Electro-medical analysis and diagnostic equipment
• Laboratory medical equipment
• Physical therapy and rehabilitation devices
• Surgical support equipment
• Medical imaging support systems
• Dental equipment
• Patient care and support equipment
• Portable and fixed medical electrical equipment

The tests performed in our laboratory include:

• Protective earthing continuity
• Insulation resistance and dielectric strength testing
• Patient leakage current and touch current measurements
• Temperature rise and thermal risk assessments
• Mechanical strength and stability testing
• Power input testing and abnormal operating condition assessments
• Single Fault Condition (SFC) analysis
• Power interruption and restart behavior testing
• Marking, documentation, and construction compliance inspections

During the testing process, not only the electrical safety of the equipment is evaluated, but also its ability to maintain critical functions safely during clinical use. Accordingly, a comprehensive conformity assessment is carried out by evaluating both Basic Safety and Essential Performance requirements.

The technical reports prepared can be used for MDR conformity assessment, product certification, type testing, technical documentation, and manufacturers' quality management systems.