EN 14683-2014 en Medical face masks - Requirements and test methods《医用面罩 要求及测试方法》.pdf

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1、BSI Standards PublicationBS EN 14683:2014Medical face masks Requirements and testmethodsBS EN 14683:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 14683:2014. Itsupersedes BS EN 14683:2005 which is withdrawn.The UK participation in its preparation was entr

2、usted to TechnicalCommittee CH/205/1, Medical textiles.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The Britis

3、h Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 78520 7ICS 11.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2014.A

4、mendments issued since publicationDate Text affectedBS EN 14683:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14683 March 2014 ICS 11.140 Supersedes EN 14683:2005English Version Medical face masks - Requirements and test methods Masques usage mdical - Exigences et mthodes dessai Medizinis

5、che Gesichtsmasken - Anforderungen und Prfverfahren This European Standard was approved by CEN on 4 February 2014. 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

6、alteration. Up-to-date 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

7、 made by translation under 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, E

8、stonia, Finland, Former Yugoslav Republic 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 United Kingdom. EUROPEAN COMMITTEE FOR S

9、TANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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 CEN national Members. Ref. No. EN 14683:2014 EBS EN 14683:2014EN 14683

10、:2014 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .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 (n

11、ormative) Method for in-vitro determination of bacterial filtration efficiency (BFE). 10 B.1 Principle . 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

12、Test report . 12 Annex C (normative) Method for determination of breathability (differential pressure) . 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 E

13、uropean Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 18 Bibliography . 19 BS EN 14683:2014EN 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 h

14、eld 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 2014 and conflicting national standards shall be withdrawn at the latest by September 2014. Attention is drawn to the possibil

15、ity that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC 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/ext

16、ension of title and scope to the more general and broader use for medical face masks; b) adjustment 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 requ

17、irements for medical face masks; e) update of Annex A on user information; f) complete revision of 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 revis

18、ion, including update of all normative references, the Bibliography and Annex ZA on the relationships 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

19、 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral 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, Be

20、lgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swit

21、zerland, Turkey and the United Kingdom. BS EN 14683:2014EN 14683:2014 (E) 4 Introduction The transmission 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 surgic

22、al team. The main intended use of medical face masks is to protect the patient from infective agents 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 pati

23、ents and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations. BS EN 14683:2014EN 14683:2014 (E) 5 1 Scope This European Standard specifies construction, design, performance requirements and test methods for medical face masks intended to limit th

24、e 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 asympt

25、omatic 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

26、users of medical face masks. 2 Normative references The following documents, in whole or in 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

27、document (including any amendments) applies. EN ISO 10993-1, Biological evaluation of medical 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 10

28、993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization (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 prot

29、ection against infectious agents Medical face masks Test method for resistance against penetration 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 cove

30、ring the mouth and nose providing a barrier to minimise the direct transmission of infective 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 ma

31、sk material(s) as a barrier to bacterial penetration Note 1 to entry: The BFE test method is 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

32、 mask under specific conditions of air flow, temperature and humidity BS EN 14683:2014EN 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 N

33、ote 1 to entry: The culturable number is the number of micro-organisms, single cells or 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.

34、1 cleanliness microbial freedom from population of viable micro-organisms on a product 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

35、be released but are not generated by mechanical impact 3.6 infective agent micro-organism 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

36、by a surgical team under controlled environmental conditions 3.8 aerosol gaseous suspension 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 ma

37、terial used for mechanical and physical separation or deposition of aerosol particles (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

38、 specified in this European Standard are classified into two types (Type I and Type II) according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. BS EN 14683:2014EN 14683:2014 (E) 7 5 Requirements 5.1 General 5.1.1 Mater

39、ials and construction The medical face mask is a medical device, generally composed 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, atten

40、tion shall be paid to cleanliness (absence of particulate matter). 5.1.2 Design The 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 shap

41、es and constructions as well as additional features such as a face shield (to protect 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 carri

42、ed out on finished products or samples cut from finished products, if applicable in 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

43、 the relevant type in Table 1. 5.2.3 Breathability When tested in accordance with Annex 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 medi

44、cal face mask to penetration of splashes of liquid shall conform to the minimum value 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

45、 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, follow the procedure below: The number of mas

46、ks that shall be tested is minimum 5 (five), but can be greater if necessary to allow for an AQL of 4 %. BS EN 14683:2014EN 14683:2014 (E) 8 Weigh each mask prior testing. The full mask is aseptically removed from the packaging and placed in a sterile 500 ml bottle containing 300 ml of extraction li

47、quid (1 g/l Peptone, 5 g/l NaCl b) type of mask (as indicated in Table 1). EN ISO 15223-1 and EN 1041 should be considered. BS EN 14683:2014EN 14683:2014 (E) 9 Annex A (informative) Information for users When breathing, speaking, coughing, sneezing etc., one releases smaller or larger amounts of dro

48、plets of secretions from the mucous membranes in the mouth and nose. The majority of the nuclei are between 0,5 m and 12 m in diameter and especially the larger droplets can contain micro-organisms from the source site. Nuclei can subsequently spread through the air to a susceptible site such as an

49、open operating wound or sterile equipment. The medical face masks intended to be used in operating rooms and health care settings with similar requirements are designed to protect the entire working environment. This standard describes two types of medical face masks with associated protection levels. As a minimum, Type I medical face masks are used for patients in order to reduce the risk of the spread of infections, particularly in epidemic or pandemic situations. Type II masks are principally intended for use by healthcare professionals in an operati