Medical devices save lives. The sooner you can get your medical device out to the market, the sooner it can help people. But before you can do that, you need to achieve medical device compliance. Patients and users expect medical devices to be safe. Using medical devices should improve their health and even save their lives.

That’s why proving medical device compliance is important. It guarantees patients that the device they are using is, in fact, safe.  And the ultimate goal of developing a medical device is to help patients. If your device isn’t safe, you’ll risk patients getting hurt. The best way to do it is to do medical device testing. Currently, we are offering the testing of the medical devices as per the below mentioned 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
  • 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 haemodialysis, 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 afterloading 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 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 lithotripsy
  • 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 interventional 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 mammomagraphic 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 haemostasis 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

To get the quote on any above standards testing, please submit your detailed query by clicking here, so that our team can provide you our best proposal.