PREN 14683 : DRAFT 2017
Current
The latest, up-to-date edition.
MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
12-01-2013
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 |
| 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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