Is it necessary to fully check the safety and EMC of the whole medical device products before leaving the factory?How to do it usually?

1, do not need to full inspection safety and EMC. reasons:

- According to the "General Administration on the release of medical device manufacturers quality control and finished product release guide notice (No. 173 of 2016)" stipulates that: finished product inspection procedures should in principle cover the registered or filed product technical requirements need to be routinely controlled in the test items and test methods. cannot be covered, should be explained in the finished product inspection protocol . If necessary, should be given to the confirmed alternative solutions.

For cost reasons, the general enterprise does not have the conditions of the full inspection of safety and EMC, and voltage test and so on are destructive testing, so basically sampling.

2, the usual practice:

Each batch of factory sampling safety regulations three: voltage test, leakage current test, protective grounding.

Voltage resistance is destructive test, but the end of the safety test, after the performance test can still be qualified, is available for continued use.