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BS EN 14683:2014 Medical face masks. Requirements and test methods, 2014
- Contents Page
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Classification
- 5 Requirements [Go to Page]
- Table 1 — Performance requirements for medical face masks
- 6 Labelling and information to be supplied
- Annex A (informative) Information for users
- 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
- 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
- B.6 Procedure
- B.7 Calculation of bacterial filtration efficiency
- B.8 Test report
- Figure B.1 — Principle of BFE test apparatus
- Figure B.2 — BFE test apparatus
- Annex C (normative) Method for determination of breathability (differential pressure)
- C.1 Principle
- Figure C.1 — Apparatus for measuring air resistance
- 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
- 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
- Bibliography [Go to Page]