In vitro diagnostic equipment environmental test requirements

  In vitro diagnostic equipment generally defines the environmental conditions in its instructions or labels, so whether domestic products or imported products,When the in vitro diagnostic equipment for product registration and the environmental conditions of use of the approved product are changed, or when the specification is changed,All relevant documents must be submitted for environmental testing to verify the safety and effectiveness of the declared product under its claimed environmental conditions.

  1. The declared product has applicable mandatory standards, and GB/T 14710 is quoted in the standard. The environmental test shall be the content of the technical requirements of the product.Refer to the requirements of the mandatory standards for reference. Generally, it is not necessary to specify the experimental conditions in detail. It only needs to state that “the content of the applicable section of GB/T 14710 should be met”, and the contents of the environmental test should be included in the registration inspection report.

  2. There is no applicable mandatory standard for the declared products, and one of the following forms can be submitted as the verification data that the environmental conditions have no effect on the safety of the product, and the technical requirements of the product do not need to refer to GB/T 14710:

   (1) A registration inspection report containing environmental tests.

  (2Entrusted inspection report for environmental testing.

  (3Research data that environmental conditions have no impact on product safety effectiveness, including: climatic environmental conditions (temperature, humidity), mechanical environmental conditions (vibration, collision), transportation conditions, power supply adaptability, etc.