BS EN 14683:2019
$142.49
Medical face masks. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 26 |
This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1 Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2 Annex A provides information for the users of medical face masks.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 8 | 1 Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 Classification 5 Requirements 5.1 General 5.1.1 Materials and construction 5.1.2 Design 5.2 Performance requirements 5.2.1 General 5.2.2 Bacterial filtration efficiency (BFE) 5.2.3 Breathability 5.2.4 Splash resistance |
| 11 | 5.2.5 Microbial cleanliness (Bioburden) 5.2.6 Biocompatibility 5.2.7 Summary of performance requirements 6 Marking, labelling and packaging |
| 13 | Annex A (informative)Information for users |
| 14 | Annex B (normative)Method for in vitro determination of bacterial filtration efficiency (BFE) B.1 General B.2 Principle B.3 Reagents and materials B.3.1 General B.3.2 Tryptic soy agar B.3.3 Tryptic soy broth |
| 15 | B.3.4 Peptone water B.3.5 Culture of Staphylococcus aureus ATCC 6538, growing on tryptic soy agar slants. B.4 Test apparatus B.4.1 Six stage cascade impactor, the arrangement is specified in Table B.1. B.4.2 Nebulizer, capable of delivering particles with a mean size of (3,0 ± 0,3) μm when in contact with the cascade impactor. B.4.3 Aerosol chamber, glass, 600 mm long and 80 mm in external diameter. B.4.4 Flow meters, capable of measuring a flow rate of 28,3 l/min. B.4.5 Pressure gauge, capable of measuring a pressure of 35 kPa to an accuracy of ± 1 kPa. B.4.6 Erlenmeyer flasks, 250 ml and 500 ml capacity. B.4.7 Peristaltic or syringe pump, capable of delivering 0,01 ml/min. B.4.8 Vacuum pump, capable of maintaining a flow rate of 57 l/min. B.5 Test specimens B.6 Preparation of bacterial challenge |
| 16 | B.7 Procedure |
| 18 | B.8 Calculation of bacterial filtration efficiency (BFE) B.9 Test report |
| 20 | Annex C (normative)Method for determination of breathability (differential pressure) C.1 Principle |
| 21 | C.2 Test apparatus C.2.1 Mass flow meter(s) capable of measuring an airflow of 8 l/min. C.2.2 Manometer, a differential manometer (water or digital). Individual manometers can also be used. M1 is for the upstream pressure measurement and M2 is for the downstream pressure measurement. C.2.3 Electric vacuum pump including a pressure buffer tank. C.2.4 Valve permitting the adjustment of the flow rate. C.2.5 Sample holder C.3 Test specimens |
| 22 | C.4 Procedure C.5 Calculation of differential pressure C.6 Test report |
| 23 | Annex D (informative)Microbial cleanliness D.1 Sampling D.2 Testing |
| 24 | Annex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered |
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BS EN 14683:2019
Medical face masks. Requirements and test methods Published By Publication Date Number of Pages BSI…
