17/30359567 DC : 0
NA
Status of Standard is Unknown
BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
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
BS EN 14683.
| Committee |
CH/205/1
|
| DocumentType |
Draft
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| Standards | Relationship |
| PREN 14683 : DRAFT 2017 | 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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