UNI EN 14683 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
04-10-2022
01-01-2014
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
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 |
U42.01
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN 14683 : 2014 | Identical |
| SN EN 14683 : 2014 | Identical |
| DIN EN 14683:2014-07 | Identical |
| NEN EN 14683 : 2014 | Identical |
| BS EN 14683:2014 | Identical |
| EN 14683:2014 | Identical |
| NBN EN 14683 : 2014 | Identical |
| I.S. EN 14683:2014 | Identical |
| EN 14683:2019 | Identical |
| NS EN 14683 : 2014 | Identical |
| NF EN 14683 : 2014 | Identical |
| UNE-EN 14683:2006 | 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 |
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