1. Since medical raw material powders directly impact human health, strict standards must be established to ensure the quality and safety of these materials. Standards for medical raw materials encompass the following aspects:
Quality Standards: Indicators covering appearance, purity, assay content, impurities, and similar parameters.
Safety Standards: Indicators covering microbial limits, limits on hazardous substances, and similar parameters.
Application-Specific Standards: The establishment of distinct raw material standards tailored to the varying intended uses of specific medical devices or pharmaceutical products.
2. To ensure that medical raw material powders comply with established standards, the raw materials must undergo rigorous testing. Testing methods for medical raw materials include the following categories:
Physical Testing: Indicators covering appearance, particle size distribution, specific gravity, viscosity, and similar parameters.
Chemical Testing: Indicators covering purity, assay content, impurities, and similar parameters.
Microbiological Testing: Indicators covering total viable count (total bacterial count), total mold count, *E. coli* levels, and similar parameters.