European standards:
EN 149 – Respiratory protective devices – Filtering half masks to protect against particles
EN 14325 – Protective clothing against chemicals
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
Chinese standards:
GB/T 32610-2016 Technical specification of daily protective mask
GB 19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use
GB 2626-2006 – Respiratory protective equipment – non-powered air-purifying particle respirator
American standards:
American regulations (FDA*):
21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR Part 820. Quality System Regulation.
* FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
Code of Federal Regulations (CFR). FDA’s portion of the CFR is in Title 21. The regulations enable a common understanding of the regulatory process by describing the requirements to be followed by drug manufacturers, applicants, and FDA.