EN 149 – Respiratory protective devices – Filtering half masks to protect against particles
EN 14325 – Protective clothing against chemicals
EN 14126:2003 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
BS EN 13795-1:2019 Surgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns
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
ASTM F1862 / F1862M – 17 – Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
ASTM F2100-19 – Standard Specification for Performance of Materials Used in Medical Face Masks , bacterial filtration efficiency, differential pressure, fluid resistance, general use, medical face masks, particle filtration efficiency, sub-micron filtration
American regulations (FDA*):
21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
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.