IEC 60601-1 Testing

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What is IEC 60601-1?

IEC 60601-1 is an international standard published by the International Electro–technical Commission (IEC) for the safety and essential performance of medical electrical equipment. There is IEC 60601 series of standards, which is for basic safety & essential performance of different Medical devices.

What is Medical Electrical Equipment?

Medical electrical equipment is the equipment used in the Medical sector for diagnosis, treatment, or monitoring of a PATIENT. As per the standard language Medical electrical equipment is an equipment which is having an APPLIED PART or which is transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT, and having not more one connection to Supply Mains. Some example of Medical devices are as follows:

  1. High-Frequency Surgical Generator
  2. Short-wave therapy equipment
  3. Cardiac defibrillators
  4. Ultrasonic physiotherapy equipment
  5. Therapeutic X-ray equipment operating in the range 10 kV to 1 MV
  6. Nerve and muscle simulators
  7. Critical care ventilators
  8. Endoscopic equipment
  9. Infant incubators
  10. Infant transport incubators
  11. Infant radiant warmers
  12. Transcutaneous partial pressure monitoring equipment
  13. Infusion pumps and controllers
  14. Invasive blood pressure monitoring equipment
  15. Ultrasonic medical diagnostic and monitoring equipment
  16. Operating tables
  17. Medical beds
  18. OT Lights
  19. Neuro-therapy Equipment’s


For List of IEC 60601 Series of Standards:

IEC 60601 series have one General Standard, 8 Collateral Standard and 52 Particular Standards:

 

General Standard

IEC 60601-1-1 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance

Collateral Standards

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 60601-1-6 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 electrical systems used in the home healthcare environment

 

IEC 60601-1-12 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

 

 

Particular Standards

IEC 60601-2-1 Medical electrical equipment – Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

 

IEC 60601-2-2 Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories

 

IEC 60601-2-3 Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

 

IEC 60601-2-4 Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

 

IEC 60601-2-5 Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

 

IEC 60601-2-6 Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

 

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 and essential performance of nerve and muscle stimulators

 

IEC 60601-2-11 Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

 

IEC 60601-2-12 Medical electrical equipment – Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators

 

IEC 60601-2-16 Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, haemodiafiltration, and haemofiltration equipment

 

IEC 60601-2-17 Medical electrical equipment – Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy after–loading equipment

 

IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

 

IEC 60601-2-19 Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

 

IEC 60601-2-20 Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

 

IEC 60601-2-21 Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

 

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 60601-2-23 Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

 

IEC 60601-2-24 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

 

IEC 60601-2-25 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

 

IEC 60601-2-26 Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

 

IEC 60601-2-27 Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

 

IEC 60601-2-28 Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

 

IEC 60601-2-29 Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

 

IEC 60601-2-31 Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with an internal power source

 

IEC 60601-2-33 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

 

IEC 60601-2-34 Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

 

IEC 60601-2-36 Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithography

 

IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

 

IEC 60601-2-39 Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

 

IEC 60601-2-40 Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

 

IEC 60601-2-41 Medical electrical equipment – Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

 

IEC 60601-2-43 Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for intervention procedures

 

IEC 60601-2-44 Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

 

IEC 60601-2-45 Medical electrical equipment – Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

 

IEC 60601-2-46 Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

 

IEC 60601-2-47 Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

 

IEC 60601-2-49 Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

 

IEC 60601-2-50 Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

 

IEC 60601-2-52 Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

 

IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential 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 and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

 

IEC 60601-2-62 Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high-intensity therapeutic ultrasound (HITU) equipment

 

IEC 60601-2-63 Medical electrical equipment – Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

 

IEC 60601-2-64 Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

 

IEC 60601-2-65 Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

 

IEC 60601-2-66 Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

 

IEC 60601-2-68 Electrical medical equipment – Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment, and radionuclide beam therapy equipment

 

IEC 60601-2-75 Medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

 

IEC 60601-2-76:2018 Medical electrical equipment – Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas hemostasis equipment

 

IEC 60601-2-83:2019 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

 

IEC 60601-2-84:2018 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of emergency and transport ventilators

 

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