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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.
The huge range of electrical products that require testing for safety and performance include:
electro-medical devices and systems, defibrillators, muscle and nerve stimulators, pulmonary
deaerators, endoscopy devices, infusion pumps and compensators, blood pressure monitoring
devices, ultrasonic medical diagnostic and monitoring equipment, x-ray devices used for
radioscopy and fluoroscopy, radiographic generators for radiogenic diagnostic groups, in-vitro
diagnostic medical devices (IVD) and implantable devices and pacemakers.
OUR APPROACH TO MEDICAL ELECTRONICS TESTING
In order to assess the safety compliance of your medical devices, Bureau Veritas has
comprehensive testing facilities all over the world for checking electrical safety, electromagnetic
compatibility and wireless technology.
We provide test reports and certificates according to CB Scheme and ILAC accreditation. Through
our NRTL appointment in USA and global labs, we can also provide product safety compliance for
the United States and Canada (FDA and Health Canada) including OSHA NRTL certification; 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)
- Eco-environment (hazardous substances analysis, lifecycle analysis)
- Electromagnetic fields (EMF)
- Mechanic and climatic
Sample regulations and standards for medical electronics:
|Electrical safety||Electromagnetic compatibility|
|IEC/EN/NF 60601-1(ed.2);am.1; am.2||IEC/EN/NF 60601-1-2 (ed.2 et 3)|
|IEC/EN/NF 60601-1(ed.3)||IEC/EN/NF 61326|
|IEC/EN/NF 60601-1-x||FCC part 18|
|IEC/EN/NF 60601-2-x||FCC part 15|