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

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Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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
EN ISO 139:2005/A1:2011	Textiles - Standard atmospheres for conditioning and testing - Amendment 1 (ISO 139:2005/AMD 1:2011)
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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