Electrical Safety Test for Class II Medical Equipment

Electrical safety testing service for Class II medical devices utilizing double insulation or reinforced insulation without protective earth connection, in accordance with IEC 60601-1 and IEC 62353 requirements.

Applicable to double-insulated medical devices including selected laboratory devices, diagnostic systems, portable equipment, and specialty healthcare electronics.

Included Test Procedures:

• Visual Inspection
• Enclosure Leakage Current Test
• Touch Leakage Current Test
• Patient Leakage Current Test
• Patient Auxiliary Current Test (if applicable)
• Applied Part Leakage Current Test (Type B/BF/CF)
• Insulation Resistance Test
• Dielectric Withstand (Hipot) Test
• Functional Safety Verification
• Polarity Verification (if applicable)
• Power Cord & Plug Inspection
• Labeling & Safety Marking Verification

Example Equipment:

• Portable Vital Signs Monitor
• Portable ECG Machine
• Portable Ultrasound System
• Dental Equipment
• Portable Suction Unit
• Rehabilitation Devices
• Physiotherapy Equipment
• Dermatology Laser Systems
• Portable Diagnostic Devices
• Home Healthcare Devices
• Medical Chargers & Adapters

Deliverables:

• Electrical Safety Test Report
• Pass/Fail Assessment 
• Leakage Current Measurements (optional)
• Compliance Documentation (optional)
• Safety Inspection Label (optional)