Name: DIN EN 14683 E : 2014
Brand: DIN

DIN EN 14683 E : 2014

Superseded

View Superseded by

MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS

Superseded date

06-03-2019

Published date

01-12-2013

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
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)
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

Provides 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.

DocumentType	Standard
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN 14683 E:2019

Standards	Relationship
ONORM EN 14683 : 2014	Identical
SN EN 14683 : 2014	Identical
EN 14683:2019	Identical
I.S. EN 14683:2014	Identical
NS EN 14683 : 2014	Identical
NEN EN 14683 : 2014	Identical
BS EN 14683:2014	Identical
NBN EN 14683 : 2014	Identical
NF EN 14683 : 2014	Identical
EN 14683:2014	Identical
UNI EN 14683 : 2014	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
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)