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- Contents Page
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Classification
- 5 Requirements
- 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.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.3.6 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
- Annex C (normative)Method for determination of breathability (differential pressure)
- Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
- Bibliography
- EN_14683_(E)_[Publication_draft for CEN].pdf
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EN 14683_2014_Medical face masks — Requirements and test methods 医用口罩要求
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