MDD Main contents include:
1, must be safe;
2, must be based on the currently recognized process technology design and manufacturing;
3, must achieve the expected performance;
4, in the specified life period must ensure the safety and performance of the product.
(5) Appropriate transportation and storage requirements must be specified;
6, side effects must be within the acceptable range;
7, chemical, physical and biological characteristics, such as: toxicity, biological compatibility, etc., must be within the permissible range;
8. Infection and microbial contamination must be within an acceptable range;
9, combined with other equipment, must consider the impact of environmental conditions (such as EMC, etc.);