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17/30359567 DC : 0

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NA

Status of Standard is Unknown

BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS

Available format(s)

Hardcopy , PDF

Language(s)

English

€23.37
Excluding VAT

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Marking, labelling and packaging
Annex A (informative) - Information for users
Annex B (normative) - Method for in vitro
        determination of bacterial filtration
        efficiency (BFE)
Annex C (normative) - Method for determination
        of breathability (differential pressure)
Annex D (informative) - Microbial cleanliness
Annex ZA (informative) - Relationship between
         this European Standard and the essential
         requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered
Bibliography

BS EN 14683.

Committee
CH/205/1
DocumentType
Draft
Pages
26
PublisherName
British Standards Institution
Status
NA

Standards Relationship
PREN 14683 : DRAFT 2017 Identical

EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
EN 132:1998 Respiratory protective devices - Definitions of terms and pictograms
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 22609:2004 Clothing for protection against infectious agents Medical face masks Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 139:2005 Textiles — Standard atmospheres for conditioning and testing
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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