DIN EN 14683-2014 Medical face masks - Requirements and test methods German version EN 14683 2014《医用面罩 要求和试验方法 德文版本EN 14683-2014》.pdf

1、July 2014Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11

2、.140!%2Z“2159755www.din.deDDIN EN 14683Medical face masks Requirements and test methods;English version EN 14683:2014,English translation of DIN EN 14683:2014-07Medizinische Gesichtsmasken Anforderungen und Prfverfahren;Englische Fassung EN 14683:2014,Englische bersetzung von DIN EN 14683:2014-07Mas

3、ques usage mdical Exigences et mthodes dessai;Version anglaise EN 14683:2014,Traduction anglaise de DIN EN 14683:2014-07SupersedesDIN EN 14683:2006-02www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 21 pages06.14 DIN EN 14683:2014-072 A

4、comma is used as the decimal marker. National foreword This document (EN 14683:2014) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, (Secretariat: DIN, Germany). The responsible German bodies involved in its preparation were the Normenausschuss Medizin (Medical Stan

5、dards Committee) and the Normenausschuss Textil und Textilmaschinen (Textilnorm) (Textiles and Textile Machinery Standards Committee), Joint Working Committee NA 063-01-08 GA Operationstextilien. Amendments This standard differs from DIN EN 14683:2006-02 as follows: a) the title and scope have been

6、changed and extended to the more general and broader use for medical face masks; b) the standard has been adjusted to meet the requirements in ISO 22609 concerning the resistance to liquid splashes; c) requirements for microbiological purity and general biocompatibility have been added; d) Table 1 h

7、as been adjusted in the area of performance requirements for medical face masks; e) Annex A concerning user information has been updated; f) Annex B (on the method for in-vitro determination of the bacterial filter performance) has been completely revised, in particular with regard to the testing co

8、nditions and the structure of the test apparatus; g) the standard has been completely editorially revised, including the updating of all normative references, the bibliography and Annex ZA concerning the relationship to the EU Directive 93/42/EEC. Previous editions DIN EN 14683: 2006-02 EN 14683 Mar

9、ch 2014 ICS 11.140 Supersedes EN 14683:2005English Version Medical face masks - Requirements and test methods Masques usage mdical - Exigences et mthodes dessai Medizinische Gesichtsmasken - Anforderungen und Prfverfahren This European Standard was approved by CEN on 4 February 2014. CEN members are

10、 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-date lists and bibliographical references concerning such national standards may be obtained on application to t

11、he 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 under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Cen

12、tre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuan

13、ia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for C

14、EN national Members. Ref. No. EN 14683:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 14683:2014 (E) 2 Contents PageForeword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and def

15、initions .5 4 Classification 6 5 Requirements .7 5.1 General 7 5.2 Performance requirements .7 6 Labelling and information to be supplied .8 Annex A (informative) Information for users 9 Annex B (normative) Method for in-vitro determination of bacterial filtration efficiency (BFE). 10 B.1 Principle

16、. 10 B.2 Reagents and materials . 10 B.3 Apparatus 11 B.4 Test specimens . 11 B.5 Preparation of bacterial challenge 11 B.6 Procedure 12 B.7 Calculation of bacterial filtration efficiency . 12 B.8 Test report . 12 Annex C (normative) Method for determination of breathability (differential pressure)

17、. 15 C.1 Principle . 15 C.2 Apparatus 16 C.3 Test specimens . 16 C.4 Procedure 16 C.5 Calculation of differential pressure 16 C.6 Test report . 16 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 18 Bibliog

18、raphy . 19 DIN EN 14683:2014-07EN 14683:2014 (E) 3 Foreword This document (EN 14683:2014) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publ

19、ication of an identical text or by endorsement, at the latest by September 2014 and conflicting national standards shall be withdrawn at the latest by September 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENE

20、LEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14683:2005. In respect to EN 14683:2005, the following changes have been made: a) change/extension of title and scope to the more general and broader use for medical face masks; b) adjustment

21、 to ISO 22609 concerning the request for resistance to liquid splashes; c) addition of requirements for microbiological purity and general biocompatibility; d) adjustment of Table 1 on performance requirements for medical face masks; e) update of Annex A on user information; f) complete revision of

22、Annex B on method for in-vitro determination of the bacterial filter performance in particular with regard to the testing conditions and the structure of the test apparatus; g) complete editorial revision, including update of all normative references, the Bibliography and Annex ZA on the relationshi

23、ps to the EU Directive 93/42/EEC. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an inte

24、gral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republ

25、ic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 14683:2014-07EN 14683:2014 (E) 4 Introduction The tr

26、ansmission of infective agents during surgical procedures in operating theatres and other medical settings can occur in several ways. Sources are, for example, the noses and mouths of members of the surgical team. The main intended use of medical face masks is to protect the patient from infective a

27、gents and, additionally, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids and viable particles. Medical face masks may also be intended to be worn by patients and other persons to reduce the risk of spread of infections, particularly in epidemic or

28、pandemic situations. DIN EN 14683:2014-07EN 14683:2014 (E) 5 1 Scope 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 ot

29、her 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 applicabl

30、e 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. 2 Normative references The following documents, in whole or in

31、 part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN ISO 10993-1, Biological evaluation of medic

32、al devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1) EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity (ISO 10993-5) EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sen

33、sitization (ISO 10993-10) EN ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products (ISO 11737-1) ISO 22609, Clothing for protection against infectious agents Medical face masks Test method for resistance against pene

34、tration by synthetic blood (fixed volume, horizontally projected) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 medical face mask medical device covering the mouth and nose providing a barrier to minimise the direct transmission of infectiv

35、e agents between staff and patient Note 1 to entry: Transmission of blood-borne agents from patients to staff may occur via splashes. 3.2 bacterial filtration efficiency (BFE) efficiency of the medical face mask material(s) as a barrier to bacterial penetration Note 1 to entry: The BFE test method i

36、s used to measure the bacterial filtration efficiency (BFE) of medical face mask materials. 3.3 differential pressure air permeability of the mask, measured by determining the difference of pressure across the mask under specific conditions of air flow, temperature and humidity DIN EN 14683:2014-07E

37、N 14683:2014 (E) 6 Note 1 to entry: The differential pressure is an indicator of the “breathability“ of the mask. 3.4 colony forming unit (cfu) unit by which the culturable number of micro-organisms is expressed Note 1 to entry: The culturable number is the number of micro-organisms, single cells or

38、 aggregates, able to form colonies on a solid nutrient medium. 3.5 cleanliness freedom from unwanted foreign matter Note 1 to entry: Such matter can be micro-organisms, organic residues or particulate matter. 3.5.1 cleanliness microbial freedom from population of viable micro-organisms on a product

39、and/or a package Note 1 to entry: In practical use, microbial cleanliness is often referred to as “bioburden“. 3.5.2 cleanliness particulate matter freedom from particles that are contaminating a material and can be released but are not generated by mechanical impact 3.6 infective agent micro-organi

40、sm that has been shown to cause surgical wound infections or that might cause infection in the patient, members of staff or other 3.7 surgical procedure surgical intervention penetrating skin or mucosa, performed by a surgical team under controlled environmental conditions 3.8 aerosol gaseous suspen

41、sion of solid and/or liquid particles, the particles having a negligible falling velocity Note 1 to entry: See EN 132. Note 2 to entry: This velocity is generally considered to be less than 0,25 m/s. 3.9 filter material used for mechanical and physical separation or deposition of aerosol particles (

42、liquid or solid) from the inhaled and exhaled air 3.10 splash resistance ability of a medical face mask to withstand penetration of synthetic blood projected at a given pressure 4 Classification Medical face masks specified in this European Standard are classified into two types (Type I and Type II)

43、 according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. DIN EN 14683:2014-07EN 14683:2014 (E) 7 5 Requirements 5.1 General 5.1.1 Materials and construction The medical face mask is a medical device, generally composed

44、 of a filter layer that is placed, bonded or moulded between layers of fabric. The medical face mask shall not disintegrate, split or tear during intended use. In the selection of the filter and layer materials, attention shall be paid to cleanliness (absence of particulate matter). 5.1.2 Design The

45、 medical face mask shall have a means by which it can be fitted closely over the nose, mouth and chin of the wearer and which ensures that the mask fits closely at the sides. Medical face masks may have different shapes and constructions as well as additional features such as a face shield (to prote

46、ct the wearer against splashes and droplets) with or without anti-fog function, or a nose bridge (to enhance fit by conforming to the nose contours). 5.2 Performance requirements 5.2.1 General All tests shall be carried out on finished products or samples cut from finished products, if applicable in

47、 their sterile state. 5.2.2 Bacterial filtration efficiency (BFE) When tested in accordance with Annex B, the bacterial filtration efficiency (BFE) of the medical face mask shall conform to the minimum value given for the relevant type in Table 1. 5.2.3 Breathability When tested in accordance with A

48、nnex C, the differential pressure of the medical face mask shall conform to the value given for the relevant type in Table 1. 5.2.4 Splash resistance When tested in accordance with ISO 22609 the resistance of the medical face mask to penetration of splashes of liquid shall conform to the minimum val

49、ue given for Type IIR in Table 1. 5.2.5 Microbial cleanliness (Bioburden) When tested according to EN ISO 11737-1 the bioburden of the medical mask shall be 30 cfu/g tested (see Table 1). NOTE EN ISO 11737-1 specifies requirements and provides guidance for the enumeration and microbial characterisation of the population of viable microorganisms on or in a medical device, component, raw material or package. To determine the masks bioburden according to EN ISO 11737-1,