《EN 14683-2019+AC-2019医用口罩 要求和试验方法》由会员分享，可在线阅读，更多相关《EN 14683-2019+AC-2019医用口罩 要求和试验方法（23页珍藏版）》请在金锄头文库上搜索。
1、 EUROPEAN STANDARD NORME EUROP ENNE EUROP ISCHE NORM EN 14683 2019 AC August 2019 ICS 11 140 English Version Medical face masks Requirements and test methods Masques usage m dical Exigences et m thodes d essai Medizinische Gesichtsmasken Anforderungen und Pr fverfahren This European Standard was app
2、roved by CEN on 19 November 2018 and includes Corrigendum AC approved by CEN on 19 November 2018 CEN members are bound to comply with the CEN CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up to d
3、ate lists and bibliographical references concerning such national standards may be obtained on application to the CEN CENELEC Management Centre or to any CEN member This European Standard exists in three official versions English French German A version in any other language made by translation unde
4、r the responsibility of a CEN member into its own language and notified to the CEN CENELEC Management Centre has the same status as the official versions CEN members are the national standards bodies of Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Gre
5、ece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Republic of North Macedonia Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey and United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROP EN DE NORMALISATION EUROP ISCHES K
6、OMITEE F R NORMUNG CEN CENELEC Management Centre Rue de la Science 23 B 1040 Brussels 2019 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 14683 2019 AC 2019 E EN 14683 2019 AC 2019 E 2 Contents Page European foreword 4 Introduction 5
7、 1 Scope 6 2 Normative references 6 3 Terms and definitions 6 4 Classification 8 5 Requirements 8 5 1 General 8 5 1 1 Materials and construction 8 5 1 2 Design 8 5 2 Performance requirements 8 5 2 1 General 8 5 2 2 Bacterial filtration efficiency BFE 8 5 2 3 Breathability 8 5 2 4 Splash resistance 8
8、 5 2 5 Microbial cleanliness Bioburden 9 5 2 6 Biocompatibility 9 5 2 7 Summary of performance requirements 9 6 Marking labelling and packaging 9 Annex A informative Information for users 11 Annex B normative Method for in vitro determination of bacterial filtration efficiency BFE 12 B 1 General 12
9、B 2 Principle 12 B 3 Reagents and materials 12 B 3 1 General 12 B 3 2 Tryptic soy agar 12 B 3 3 Tryptic soy broth 12 B 3 4 Peptone water 13 B 3 5 Culture of Staphylococcus aureus ATCC 6538 growing on tryptic soy agar slants 13 B 4 Test apparatus 13 B 4 1 Six stage cascade impactor the arrangement is
10、 specified in Table B 1 13 B 4 2 Nebulizer capable of delivering particles with a mean size of 3 0 0 3 m when in contact with the cascade impactor 13 B 4 3 Aerosol chamber glass 600 mm long and 80 mm in external diameter 13 B 4 4 Flow meters capable of measuring a flow rate of 28 3 l min 13 B 4 5 Pr
11、essure gauge capable of measuring a pressure of 35 kPa to an accuracy of 1 kPa 13 EN 14683 2019 AC 2019 E 3 B 4 6 Erlenmeyer flasks 250 ml and 500 ml capacity 13 B 4 7 Peristaltic or syringe pump capable of delivering 0 01 ml min 13 B 4 8 Vacuum pump capable of maintaining a flow rate of 57 l min 13
12、 B 5 Test specimens 13 B 6 Preparation of bacterial challenge 13 B 7 Procedure 14 B 8 Calculation of bacterial filtration efficiency BFE 15 B 9 Test report 16 Annex C normative Method for determination of breathability differential pressure 18 C 1 Principle 18 C 2 Test apparatus 19 C 2 1 Mass flow m
13、eter s capable of measuring an airflow of 8 l min 19 C 2 2 Manometer a differential manometer water or digital Individual manometers can also be used M1 is for the upstream pressure measurement and M2 is for the downstream pressure measurement 19 C 2 3 Electric vacuum pump including a pressure buffe
14、r tank 19 C 2 4 Valve permitting the adjustment of the flow rate 19 C 2 5 Sample holder 19 C 3 Test specimens 19 C 4 Procedure 20 C 5 Calculation of differential pressure 20 C 6 Test report 20 Annex D informative Microbial cleanliness 21 D 1 Sampling 21 D 2 Testing 21 Annex ZA informative Relationsh
15、ip between this European Standard and the essential requirements of Directive 93 42 EEC 1993 OJ L 169 aimed to be covered 22 Bibliography 23 EN 14683 2019 AC 2019 E 4 European foreword This document EN 14683 2019 AC 2019 has been prepared by Technical Committee CEN TC 205 Non active medical devices
16、the secretariat of which is held by DIN This European Standard shall be given the status of a national standard either by publication of an identical text or by endorsement at the latest by September 2019 and conflicting national standards shall be withdrawn at the latest by September 2019 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN shall not be held responsible for identifying any or all such patent rights This documen
