IEC Standard
IEC 60601-1-1 Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard:
Safety requirements for medical electrical systems
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential
performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-4 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 60601-1-9 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for medical electrical equipment and medical electricalsystems used in the home healthcare environment
IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety andessential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-8 Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential
performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety andessential performance of nerve and muscle stimulators
IEC 60601-2-12 Medical electrical equipment - Part 2-12: Particular requirements for the basic safety andessential performance of critical care ventilatorsIEC 60601-2-13 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential
performance of anaesthetic systems
IEC 60601-2-16 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-17 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety andessential performance of automatically controlled brachytherapy afterloading equipment
IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety andessential performance of endoscopic equipment
IEC 60601-2-19 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety andessential performance of infant incubators
IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety andessential performance of infusion pumps and controllers
IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety andessential performance of electrocardiographs
IEC 60601-2-26 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety andessential performance of electroencephalographs
IEC 60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety andessential performance of electrocardiographic monitoring equipment
IEC 60601-2-29 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety andessential performance of radiotherapy simulators
IEC 60601-2-36 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety andessential performance of equipment for extracorporeally induced lithotripsy

IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety andessential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety andessential performance of electromyographs and evoked response equipment
IEC 60601-2-41 Medical electrical equipment - Part 2-41: Particular requirements for the basic safety andessential performance of surgical luminaires and luminaires for diagnosis
IEC 60601-2-46 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety andessential performance of operating tables
IEC 60601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety andessential performance of multifunction patient monitoring equipment
IEC 60601-2-52 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety andessential performance of medical beds
IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety andessential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-57 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety andessential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring
and cosmetic/aesthetic use
IEC 60601-2-66 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety andessential performance of hearing instruments and hearing instrument systems
IEC 80601-2-26 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety andessential performance of electroencephalographs
IEC 80601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety andessential performance of multifunction patient monitoring equipment
IEC 80601-2-58 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential
performance of lens removal devices and vitrectomy devices for ophthalmic surgery
IEC 80601-2-60 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety andessential performance of dental equipment
ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential
performance of pulse oximeter equipment

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Contact
DEKRA PRODUCT TESTING
Mr. Roel Korteman
Sales Manager+31 6 4644 0839
Roel.Korteman@DEKRA.com
Mr. Tim van den Berg
Sales Manager+31 88 96 83 542
Tim.vandenBerg@DEKRA.com