BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
08-22-2019
English
04-30-2014
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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
Describes 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 |
CH/205
|
| DevelopmentNote |
Supersedes 03/306155 DC. (02/2006) Supersedes 12/30260949 DC. (04/2014)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This European Standard specifies 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. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. NOTE 1 Standards for masks for use as respiratory personal protective equipment are available. NOTE 2 Annex A provides information for the users of medical face masks.
| Standards | Relationship |
| UNE-EN 14683:2006 | Identical |
| ONORM EN 14683 : 2014 | Identical |
| SN EN 14683 : 2014 | Identical |
| I.S. EN 14683:2014 | Identical |
| NS EN 14683 : 2014 | Identical |
| NF EN 14683 : 2014 | Identical |
| DIN EN 14683:2014-07 | Identical |
| NEN EN 14683 : 2014 | Identical |
| NBN 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 |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| 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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