DIN EN 14683:2014-07
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
German
01-01-2014
03-06-2019
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Superseded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 |
| NEN EN 14683 : 2014 | Identical |
| BS EN 14683:2014 | Identical |
| NBN EN 14683 : 2014 | Identical |
| EN 14683:2014 | Identical |
| NS EN 14683 : 2014 | Identical |
| NF EN 14683 : 2014 | Identical |
| UNE-EN 14683:2006 | 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 |
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