YY 0469-2011 Translated English of Chinese Standard. YY0469-2011: Surgical maskThis Standard specifies the technical requirements, test methods, marking, instructions for use, packaging, transportation, and storage of surgical mask This Standard applies to disposable masks worn by clinical medical personnel during invasive operations. |
Contents
| 3 | |
Scope | 5 |
Technical requirements | 7 |
Test methods | 9 |
Marking | 12 |
Packaging transportation and storage | 13 |
Appendix A Normative Preparation method of synthetic blood | 14 |
Appendix B Normative Test method for bacterial filtration efficiency BFE | 15 |
Bibliography | 20 |
Common terms and phrases
Aerosol chamber agar plate air pipeline allergen Amaranth dye Appendix bacterial aerosol bacterial colonies bacterial filtration efficiency bacterial suspension body fluids cm in length conversion table cytotoxicity Delayed-type hypersensitization detectable Not detectable document Ethylene oxide residue Figure B.2 filtration efficiency BFE Flame retardation properties gas chromatography GB/T geometric standard deviation humidity of 85±5 Inspect visually kPa 120 mmHg Mask belt mask material Medical Device meet the requirements method specified Microbial indicators microorganisms Nose clip Number of samples package peptone perform the test plastic material Positive hole positive quality control Preparation method pressure difference pressure of 16.0 relative humidity result shall meet Sample pretreatment sampler samples to test Schematic diagram side of mask Skin irritation sodium carboxymethylcellulose sodium chloride sprayer sterilization surface tension Surgical mask Synthetic blood penetration Table B.1 technical requirements terms and definitions test methods Test process test sample Total number trypsin soy broth Tween 20 Vacuum pump