Under What Circumstances Do Environmental Tests Need To Be Carried Out On Medical Electrical Equipment?

If the medical electrical equipment is expected to be used in a special environment (such as high temperature, high humidity or low temperature), or if the product performance and clinical effect are easily affected by environmental factors, the supporting data that the product can be used normally and stably in the corresponding environment shall be provided in the research data.

If applicable, the related requirement of GB/T 14710 should be specified in product technical requirement, and the test should be conducted according to requirement.