medical

Medical Technology
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Medical electronics is a sector which addresses the design, use, and implementation of electronic
equipment and devices for medical uses such as examination, diagnosis, research and treatment.

The market is expected to grow rapidly in the near future, including medical technology used for
therapeutics and patient monitoring, alongside homecare products and handheld products.Among other issues, the integration of wireless technology into medical devices has created a
need to demonstrate that they are safe from the effects of other radio-emitting products.

Examples of the wide variety of medical electrical products that require testing for basic safety and essential performance include: patient monitoring equipment, ophthalmic devices, dental equipment, defibrillators, muscle and nerve stimulators, ventilators, oxygen concentrators, sleep apnea / CPAP devices, haemodialysis equipment, endoscopy devices, infusion pumps, blood pressure monitoring devices, thermometers, medical heating blankets, ultrasonic medical diagnostic and monitoring equipment, medical beds, operating tables, surgical/cosmetic/therapeutic/diagnostic laser systems, , and in-vitro diagnostic medical devices (IVD).

OUR APPROACH TO MEDICAL ELECTRONICS TESTING

Bureau Veritas has comprehensive testing facilities throughout the world for evaluating the electrical safety, electromagnetic compatibility, and wireless technology of various products and systems.

We provide test reports and certificates according to CB Scheme and ILAC accreditation. Through our NRTL program, we offer certification for the US and Canadian markets; and with CBTLs worldwide, we can help you access markets worldwide.

Our support extends to a variety of fields, including:

  • Electromagnetic compatibility
  • Electrical safety
  • Wireless connectivity (2G/3G/4G-LTE, WiFi, Bluetooth, NFC, RFID, Zigbee, Zwave)
  • Alarms (60601-1-8)
  • Home Healthcare (60601-1-11) 
  • Emergency Medical Services (60601-1-12)
  • Eco-environment (hazardous substances analysis, lifecycle analysis)
  • Biocompatibility (ISO 10993 series)
  • Cybersecurity
  • Mechanical and climatic
  • Global Market Access (GMA)
  • NRTL / SCC Certification (for US and Canada)

Increased demand for advanced imaging devices and systems is driving growth of the global medical electronics market, along with a rise in chronic disease cases and a rapidly ageing population. There is also an increasing demand for wearable healthcare devices that are personalised and easy to use.

Sample regulations and standards for medical electronics:

Electrical safetyElectromagnetic compatibility
IEC/EN 60601-1(ed.3);am.1; am.2IEC/EN 60601-1-2 (ed.4.1)
IEC/EN 60601-1-XXIEC/EN 61326
IEC/EN 60601-2-XX and 80601-2-XXFCC part 18
IEC/EN 61010-1FCC part 15
IEC/EN 62368-1 

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