The tests that need to be done in the development of medical device products

The tests that need to be done in the process of developing medical device products learned in the practice process.
References:

1. https://blog.csdn.net/whik1194/article/details/103223618
2. Practical testing experience

1. EMC testing

EMC (Electro Magnetic Compatibility) Also known as Electromagnetic Compatibility (EMC), it mainly includes two meanings: EMS and EMI.EMS refers to Electromagnetic Immunity, which means that the device should be able to work normally in a certain electromagnetic environment.EMI refers to electromagnetic disturbance, that is, the electromagnetic disturbance generated by the device itself cannot have an excessive impact on other electronic products.

National Standard Electromagnetic Compatibility Test and Measurement Technology "GB/T 17626" series are as follows:

There are 28 EMC tests, comparing different medical device products, which need to be completedThe number of trials varies.We only need to complete individual test items correspondingly.

1.1 Anti-electromagnetic interference capability

Whether the device can work normally under the action of external electromagnetic waves in the 10Mhz - 2GHz frequency band, and whether the internal modules can work normally.

1.2 External Radiation Ability

When the equipment is working normally, whether the electromagnetic wave energy in the frequency band (30MHz - 1GHz) radiated to the outside world is lower than the upper limit of electromagnetic radiation proposed by the national standard.Thereby reducing electromagnetic interference to external electronic products.

1.3 Anti-static ability

Under the normal working condition of the equipment, when the outside world produces contact discharge and air discharge to the equipment, whether the equipment can work normally, and whether the internal modules can work normally.

2. Safety test

Pending test