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DIN EN 14683:2014-07

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
Available format(s)

Hardcopy , PDF

Superseded date

03-06-2019

Language(s)

German

Published date

01-01-2014

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

This standard is included in DIN Handbook 475.

DevelopmentNote
DRAFT 2017 issued in July 2017. (07/2017)
DocumentType
Standard
Pages
21
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded

Standards Relationship
I.S. EN 14683:2014 Identical
ONORM EN 14683 : 2014 Identical
SN EN 14683 : 2014 Identical
UNE-EN 14683:2006 Identical
NEN EN 14683 : 2014 Identical
BS EN 14683:2014 Identical
NBN EN 14683 : 2014 Identical
EN 14683:2014 Identical
UNI EN 14683 : 2014 Identical
NS EN 14683 : 2014 Identical
NF EN 14683 : 2014 Identical

DIN HDBK 475 : 2ED 2013
VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom
VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation

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)

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Hardcopy - German
PDF - German
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