Main Test Standards for Medical Products

There are strict requirements for medical products in every country, and EMC test is just a part of the safety standards for medical machinery products.

Medical Product Testing Requirements

Medical products exported to Europe should follow the 89/336/EEC electromagnetic compatibility directive and can be tested according to standard EN60601-1-2.


EMI is tested according to different groups and classifications and can generally be divided into:

1 group of medical equipment

2 groups of engineering equipment


EMS generally tests for life support equipment and non-life support equipment. As the name suggests, this is a good distinction. test requirements for different types are different, and the standards are more strict for life support equipment.


EU Requirements

If the medical products have passed EMI and EMS tests, then laboratory can issue the report, and follow the safety instructions, then it can meet EU export requirements.


US Requirements

Medical electronic products need to meet FDA requirements. and should apply for pre-market notification (PMN: 501K) or marketing approval (PMA) according to regulatory requirements, it is also necessary to perform medical device product registration (Listing). jobs. For the EMC part, medical electronic products can be tested according to FCC Part 18 standards, and certificates can be issued by institutions with FCC Part 18 qualification.

As a Authoritative third party certification body,DDT has full capability to perform the FCC Part 18 tests.