SIST EN 14683:2019

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske maske za obraz - Zahteve in preskusne metodeMedizinische Gesichtsmasken - Anforderungen und PrüfverfahrenMasques à usage médical - Exigences et méthodes d'essaiMedical face masks - Requirements and test methods11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 14683:2019SIST EN 14683:2019en,fr,de01-maj-2019SIST EN 14683:2019SLOVENSKI
STANDARDSIST EN 14683:20141DGRPHãþD



SIST EN 14683:2019



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14683
March
t r s { ICS
s sä s v r Supersedes EN
s v x z uã t r s vEnglish Version
Medical face masks æ Requirements and test methods Masques à usage médical æ Exigences et méthodes d 5essai
Medizinische Gesichtsmasken æ Anforderungen und Prüfverfahren This European Standard was approved by CEN on
s { November
t r s zä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
9
t r s { CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s v x z uã t r s { ESIST EN 14683:2019



EN 14683:2019 (E) 2 Contents Page European foreword . 4 Introduction . 5 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 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 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 specified in Table B.1. . 13 B.4.2 Nebulizer, capable of delivering particles with a mean size of (3,0 ± 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 Pressure gauge, capable of measuring a pressure of 35 kPa to an accuracy of ± 1 kPa. . 13 SIST EN 14683:2019



EN 14683:2019 (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 B.5 Test specimens . 13 B.6 Preparation of bacterial challenge . 13 B.7 Procedure . 14 B.8 Calculation of bacterial filtration efficiency (BFE) . 16 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 meter(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 buffer 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)
Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered . 22 Bibliography . 23
SIST EN 14683:2019



EN 14683:2019 (E) 4 European foreword This document (EN 14683:2019) 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 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 document supersedes EN 14683:2014. This document has been prepared under a standardization request 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 integral part of this document. The main changes compared to the previous edition are: a) the appropriate method for in vitro determination of bacterial filtration efficiency (BFE) provided in Annex B has been updated; b) the former deleted note in 5.2.3 on the breathability requirements has been reintroduced as standard text; it provides a recommendation regarding the use of a respiratory protective device; c) the performance requirements on the breathability (differential pressure) provided in Table 1 have been increased and the appropriate method for determination provided in Annex C has been completely reviewed; d) the determination of the microbial cleanliness (bioburden) has been slightly updated and moved from 5.2.5 to a new informative Annex D. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 14683:2019



EN 14683:2019 (E) 5 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 surgical 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. 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 pandemic situations. SIST EN 14683:2019



EN 14683:2019 (E) 6 1 Scope This document 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. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) EN ISO 11737-1:2018, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) 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) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses:
IEC Electropedia: available at http://www.electropedia.org/
ISO Online browsing platform: available at http://www.iso.org/obp 3.1 aerosol gaseous suspension of solid and/or liquid particles 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 is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials. 3.3 biocompatibility quality of being accepted in a specific living environment without adverse or unwanted side effects SIST EN 14683:2019



EN 14683:2019 (E) 7 3.4 cleanliness freedom from unwanted foreign matter Note 1 to entry: Such matter can be microorganisms, organic residues or particulate matter. 3.4.1 microbial cleanliness 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 colony forming unit CFU unit by which the culturable number of microorganisms is expressed Note 1 to entry: The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on a solid nutrient medium. 3.6 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 Note 1 to entry: The differential pressure is an indicator of the “breathability” of the mask. 3.7 filter material used for mechanical and physical separation or deposition of aerosol particles (liquid or solid) from the inhaled and exhaled air 3.8 infective agent microorganism that has been shown to cause surgical wound infections or that might cause infection in the patient, members of staff or other 3.9 medical face mask medical device covering the mouth and nose providing a barrier to minimize the direct transmission of infective agents between staff and patient Note 1 to entry: Transmission of fluid-borne agents from patients to staff may occur via splashes. 3.10 splash resistance ability of a medical face mask to withstand penetration of synthetic blood projected at a given pressure 3.11 surgical procedure surgical intervention penetrating by skin or mucosa, performed by a surgical team under controlled environmental conditions SIST EN 14683:2019



EN 14683:2019 (E) 8 4 Classification Medical face masks 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. The 'R' signifies splash resistance. 5 Requirements 5.1 General 5.1.1 Materials 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, attention shall be paid to cleanliness. 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 shapes 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 carried out on finished products or samples cut from finished products. 5.2.2 Bacterial filtration efficiency (BFE) When tested in accordance with Annex B, the BFE of the medical face mask shall conform to the minimum value given for the relevant type in Table 1. For thick and rigid masks such as rigid duckbill or cup masks the test method may not be suitable as a proper seal cannot be maintained in the cascade impactor. In these cases, another valid equivalent method shall be used to determine the BFE. When a mask consists of two or more areas with different characteristics or different layer-composition, each panel or area shall be tested individually. The lowest performing panel or area shall determine the BFE value of the complete mask. 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. If the use of a respiratory protective device as face mask is required in an operating theatre and/or other medical settings, it might not fulfil the performance requirements with regard to differential pressure as defined in this European Standard. In such case, the device should fulfil the requirement as specified in the relevant Personal Protective Equipment (PPE) standard(s). 5.2.4 Splash resistance When tested in accordance with ISO 22609:2004 the resistance of the medical face mask to penetration of splashes of liquid shall conform to the minimum value given for Type IIR in Table 1. SIST EN 14683:2019



EN 14683:2019 (E) 9 5.2.5 Microbial cleanliness (Bioburden) When tested according to EN ISO 11737-1:2018 the bioburden of the medical mask shall be
¶ 30 CFU/g tested (see Table 1). NOTE EN ISO 11737-1:2018 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package. To determine the mask’s bioburden according to EN ISO 11737-1:2018, refer to the procedure as described in Annex D. The number of masks that shall be tested is minimum 5 of the same batch/lot. Other test conditions as described in EN ISO 11737-1:2018 may be applied. In the test report, indicate the total bioburden per individual mask and based on the mask weight, the total bioburden per gram. 5.2.6 Biocompatibility According to the definition and classification in EN ISO 10993-1:2009, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the medical face mask according to EN ISO 10993-1:2009 and determine the applicable toxicology testing regime. The results of testing should be documented according to the applicable parts of the EN ISO 10993 series. The test results shall be available upon request. 5.2.7 Summary of performance requirements Table 1 — Performance requirements for medical face masks Test Type I a
Type II Type IIR Bacterial filtration efficiency (BFE), (%)
· 95
· 98
· 98 Differential pressure (Pa/cm2) < 40 < 40 < 60 Splash resistance pressure (kPa) Not required Not required
· 16,0 Microbial cleanliness (cfu/g)
¶ 30
¶ 30
¶ 30 a Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements. 6 Marking, labelling and packaging Annex I, §13, of the Medical Devices Directive (93/42/EEC) or Annex I, §23, of the Medical Device Regulation (EU) 2017/745 specifies the information that should be specified on the packaging in which the medical face mask is supplied. The following information shall be supplied: a) number of this European Standard; SIST EN 14683:2019



EN 14683:2019 (E) 10 b) type of mask (as indicated in Table 1). EN ISO 15223-1:2016 and EN 1041:2008+A1:2013 should be considered. SIST EN 14683:2019



EN 14683:2019 (E) 11 Annex A (informative)
Information for users When breathing, speaking, coughing, sneezing, etc., one releases smaller or larger amounts of droplets of secretions from the mucous membranes in the mouth and nose. The majority of the nuclei are between 0,5
from the source site. Nuclei can subsequently spread through the air to a susceptible site such as an 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 operating room or other medical settings with similar requirements. A special case, also covered by the European Medical Devices legislation, is that in which the wearer wishes to protect him/herself against splashes of potentially contaminated fluids. If the intended use of the mask is to protect the wearer against infective agents (bacteria, viruses or fungi), the use of a respirator device is applicable in accordance with the Personal Protective Equipment (PPE) Directive (89/686/EEC) or the Personal Protective Equipment (PPE) Regulation (EU) 2016/425. Performance requirements for respirators are the scope of EN 149. The level of efficiency offered by a mask depends on a number of factors such as the filtration efficiency, quality of the material and the fit of the mask on the wearer’s face. Different designs are suited for different applications and the careful choice of mask is therefore important in order to achieve the desired result. The filtration capacity of mask materials can vary depending on the filter media. The fit of masks varies considerably from those which are held in place by ear loops fastened behind the wearer’s ears to those with tie bands around the head and a nose clamp that can be shaped to the wearer’s nose.
It is usual to characterize mask performance using in vitro tests of the material from which the mask is made. It is, however, important to consider the fit of the mask carefully when a mask for a certain application is chosen. A further factor to be considered is the capacity of the mask to absorb moisture from the exhaled air and thereby to maintain its performance over a longer period of time. The more advanced designs easily maintain their performance throughout even very long operations whereas the less advanced ones are intended only for short procedures. Due to the fact that used masks are considered highly contaminated, it is essential that: — the body of the mask is not touched by the fingers/hands of the wearer; — hands are disinfected (full hand disinfection) after mask removal; — a mask is worn covering the nose and mouth of the wearer, at no time a mask is hanging around the neck of the wearer; — a used mask should be disposed of when no longer needed or between two procedures; when there is a further need for protection a new mask should be put on. SIST EN 14683:2019



EN 14683:2019 (E) 12 Annex B (normative)
Method for in vitro determination of bacterial filtration efficiency (BFE) B.1 General WARNING — Staphylococcus aureus is a pathogen. The relevant national provisions by law and hygienic instructions when dealing with pathogens shall be complied with. B.2 Principle A specimen of the mask material is clamped between a six-stage cascade impactor and an aerosol chamber. An aerosol of Staphylococcus aureus is introduced into the aerosol chamber and drawn through the mask material and the impactor under vacuum. The bacterial filtration efficiency (BFE) of the mask is given by the number of colony forming units passing through the medical face mask material expressed as a percentage of the number of colony forming units present in the challenge aerosol. For test apparatus see Figure B.3. B.3 Reagents and materials B.3.1 General B.3.2 and B.3.3 describe commercially available solutions of tryptic soy agar and tryptic soy broth. Other variants may be suitable. B.3.2 Tryptic soy agar Formula/litre
Enzymatic digest of casein 15 g Enzymatic digest of soybean meal 5 g Sodium chloride 5 g Agar 15 g Final pH
7,3 ± 0,2 at 25 °C B.3.3 Tryptic soy broth Formula/litre
Enzymatic digest of casein 17 g Enzymatic digest of soybean meal
3 g Sodium chloride 5 g Dipotassium phosphate 2,5 g Dextrose 2,5 g Final pH
7,3 ± 0,2 at 25 °C SIST EN 14683:2019



EN 14683:2019 (E) 13 B.3.4 Peptone water Formula/litre
Peptone 10 g Sodium chloride 5 g Final pH
7,2 ± 0,2 at 25 °C B.3.5 Culture of Staphylococcus aureus ATCC 6538, growing on tryptic soy agar slants. B.4 Test apparatus B.4.1 Six stage cascade impactor, the arrangement is specified in Table B.1.
B.4.2 Nebulizer, capable of delivering particles with a mean size of (3,0 ± contact with the cascade impactor. B.4.3 Aerosol chamber, glass, 600 mm long and 80 mm in external diameter. B.4.4 Flow meters, capable of measuring a flow rate of 28,3 l/min. B.4.5 Pressure gauge, capable of measuring a pressure of 35 kPa to an accuracy of ± 1 kPa. B.4.6 Erlenmeyer flasks, 250 ml and 500 ml capacity. B.4.7 Peristaltic or syringe pump, capable of delivering 0,01 ml/min. B.4.8 Vacuum pump, capable of maintaining a flow rate of 57 l/min. B.5 Test specimens Test specimens shall be cut from complete masks. A complete mask may be used in place of a cut specimen, as long as the extremities are removed, the mask is laid flat and all layers are incorporated (in case of folded masks unfold the mask in order to test a surface as flat as
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