Name: PREN 14683 : DRAFT 2017
Brand: CEN

MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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

Defines 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.

Committee	TC 205
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
17/30359567 DC : 0	Identical
NEN EN 14683 : 2014	Identical
17/30359567 DC : DRAFT JUL 2017	Identical
NF EN 14683 : 2014	Identical
03/306155 DC : DRAFT APR 2003	Identical
12/30260949 DC : 0	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)