What’ Re The Requirements For The Environmental Test Of IVD Equipment?

 IVD equipment generally defines its environmental conditions for use in its instructions or labels. The verification data of the IVD equipment for environmental testing should be submitted to confirm the safety and efficacy under its claimed environmental conditions when applying for product registration, changes of permission items and change notification of instructions for environmental conditions, regardless of domestic or imported products.

If the product has applicable mandatory standards and GB/T 14710 is referred to in the standards, the environmental test should be part of the content of the product technical requirements and referred to according to the requirements of the mandatory standard. Generally, it is not necessary to specify the experimental conditions in detail, but only to indicate “comply with the content of applicable chapters of GB/T 14710”. And the contents of the environmental test should be included in the test report.

For the product without applicable mandatory standards, one of the following documents can be submitted as verification data that environmental conditions have no interference on the decision about the safety and efficacy of the product, and there is no need to quote GB/T 14710 in product technical requirements: ①Test report including the environmental test;②Test report of environmental test; ©Research data that environmental conditions have no interference on the decision about the safety and efficacy of the product, including: climatic environmental conditions (temperature, humidity), mechanical environmental conditions (vibration, collision), transportation conditions, power supply adaptability, etc. The research should meet the requirements of GB/T 14710.