Medical device refers to any instrument, device, appliance, material or other object intended by the manufacturer for use in the human body, whether used alone or in combination, including software required for its normal use.
A: Disease diagnosis, prevention, surveillance, treatment or mitigation
B: Diagnosis, monitoring, treatment or mitigation of injury or disability
C: Exploration, substitution, or alteration of anatomical or physiological processes
D: Birth control
There are relatively stringent requirements for the entry of medical products into various countries, and the EMC portion is only part of the requirements of the parallel safety standards for exported medical machinery products.
Medical products exported to Europe must abide by the Electromagnetic Compatibility Directive 89/336/EEC and can be tested in accordance with the provisions of Standard EN60601-1-2:
For the EMI portion, products are tested according to different groups and classifications, which are generally as follows:
Group 1 engineering medical equipment
Group 2 engineering medical equipment
For the EMS portion, tests are generally divided into life support equipment and non-life support equipment. As the name implies, it is easy to distinguish. Different types of tests correspond to different requirements, and the requirements for life support equipment are relatively strict.
The EU requirements:
If a medical product passes the EMI and EMS tests, the report issued by the laboratory will be sufficient. Then, together with the safety directive, the EU export requirements can be fulfilled.
The US requirements:
Electronic medical products need to pass the FDA approval for market access. In addition to applying for Premarket Notification (PMN:510K) or Premarket Approval (PMA) as per different regulations, medical device registration and listing are also required. For the EMC Part, electronic medical products can be tested in accordance with the requirements of FCC Part 18 regulations, and the certificate can be issued by the agency with FCC Part 18 authorization.
EMTEK is fully capable of testing the FCC Part 18 medical products.