BS EN 14683:2014
$142.49
Medical face masks. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 24 |
This European Standard 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 |
|---|---|
| 4 | Contents Page |
| 5 | Foreword |
| 6 | Introduction |
| 7 | 1 Scope 2 Normative references 3 Terms and definitions |
| 8 | 4 Classification |
| 9 | 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 5.2.5 Microbial cleanliness (Bioburden) |
| 10 | 5.2.6 Biocompatibility 5.2.7 Summary of performance requirements Table 1 — Performance requirements for medical face masks 6 Labelling and information to be supplied |
| 11 | Annex A (informative) Information for users |
| 12 | Annex B (normative) Method for in-vitro determination of bacterial filtration efficiency (BFE) B.1 Principle B.2 Reagents and materials B.2.1 General B.2.2 Tryptic soy agar B.2.3 Tryptic soy broth |
| 13 | B.2.4 Peptone water B.2.5 Culture of Staphylococcus aureus ATCC 6538, growing on tryptic soy agar slants B.3 Apparatus B.3.1 Six stage cascade impactor B.3.2 Nebulizer, capable of delivering particles with a mean size of (3,0 ± 0,3) μm when in contact with the impactor B.3.3 Aerosol chamber, glass, 600 mm long and 80 mm in external diameter B.3.4 Flow meters, capable of measuring a flow rate of 28,3 l/min B.3.5 Pressure gauge, capable of measuring a pressure of 35 kPa to an accuracy of ± 1 kPa B.3.6 Erlenmeyer flasks, 250 ml and 500 ml capacity B.3.7 Peristaltic or syringe pump, capable of delivering 0,01 ml/min B.3.8 Vacuum pump, capable of maintaining a flow rate of 57 l/min B.4 Test specimens B.5 Preparation of bacterial challenge |
| 14 | B.6 Procedure B.7 Calculation of bacterial filtration efficiency B.8 Test report |
| 15 | Figure B.1 — Principle of BFE test apparatus |
| 16 | Figure B.2 — BFE test apparatus |
| 17 | Annex C (normative) Method for determination of breathability (differential pressure) C.1 Principle Figure C.1 — Apparatus for measuring air resistance |
| 18 | C.2 Apparatus C.2.1 Flow meter, capable of measuring an airflow of 8 l/min C.2.2 Manometers, M1 and M2 or differential manometer C.2.3 Electric vacuum pump C.2.4 Valve C.3 Test specimens C.4 Procedure C.5 Calculation of differential pressure C.6 Test report |
| 20 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Table ZA.1 — Correspondence between this European Standard and EU Directive 93/42/EEC concerning medical devices |
| 21 | Bibliography |
