Regulatory roadmap for mask certification

Standards of mask certification

Hygienic


EN 0064-1:2020
Single-use
For use by adults
EN 0064-2:2020
Single-use
For use by children
EN 0065:2020
Reusable hygiene
face masks for
adults and children
CWA 17553

Surgical


EN 14683

Type I - low EFB

Type II - medium EFB

TYPE IIR - medium EFB
splash-resistant

Filtering (PEE)


EN 149:2001+A1:2010

FFP1 - low efficiency

FFP2 - medium efficiency

FFP3 - high efficiency

In response to the coronavirus outbreak, CEN and CENELEC agreed, in collaboration with all their Members and after an urgent request from the European Commission, to make freely available a series of European standards (ENs) for medical devices and personal protective equipment used in the context of the COVID-19 pandemic.

Standards of mask certification

Hygienic

EN 0064-1:2020
Single-use
For use by adults
EN 0064-2:2020
Single-use
For use by children
EN 0065:2020
Reusable hygiene
face masks for
adults and children
CWA 17553

Surgical

EN 14683

Type I - low EFB

Type II - medium EFB

TYPE IIR - medium EFB
splash-resistant

Filtering (PEE)

EN 149:2001+A1:2010

FFP1 - low efficiency

FFP2 - medium efficiency

FFP3 - high efficiency

How to certificate a Face Shield?

During the pandemic, the face shield became a basic element of protection against Covid-19. In some cases, such as health or front line workers, the protection provided by the mask is not enough.

We believe that is so important that all Personal Protective Equipment is certified by European standards. During the pandemic, the urgency has allowed the use of protective equipment “do it yourself”, but this has caused some problems. Some equipment was not comfortable or effective to be used continuously for many hours.

Face shields, as any other PPE, are included in the scope of application of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC that regulates the conditions for the free circulation of personal protective equipment on the European internal market.

Face shields can be homologated through the following standards:

- For the case of Face Shields, they can be homologated from 2 standards:

  • UNE-EN 166 (facial protection)

  • UNE-EN 166 RfU 03.031 version 1 (Covid19)

- The following standards specify the tests for homologation:

  • UNE-EN 166:2002: Personal eye-protection - Specifications.

  • UNE-EN 167:2002:Personal eye-protection - Optical test methods

  • UNE-EN 168:2002: Personal eye-protection - Non-optical test methods.

Next, we will explain in more detail the rules.

  • UNE-EN 166:2002 is essential since it explains the specifications and details of the tests that face shields must pass. In this standard, there are specifications for various types of protectors, such as protection against gas and dust particles or electric arcs.

    Therefore, the first step to determine which tests the protector must pass is to identify it. In our case, we have tested it as Class 3 protection against drops and liquid splashes.

  • UNE 167:2002 details the procedure for optical tests, their specifications, procedures and results.

  • UNE 168:2002 details the procedure for non-optical tests, their specifications, procedures and results. This standard tests the fire proofness or resistance of the materials.

Here you can find the abstracts of these standards.

Currently, the EU has released an update of the standard: RfU 03.031 version 1, considered as a simplification of standard 166:2001 and only serves as protection against the SARS-CoV-2. It does not have to pass all the tests of 166:2001 (Class III) and it can be certified by this version of the standard.

Furthermore, the process is much faster (it changes from 3 or 4 weeks to 2 weeks) and requires fewer samples.

Once the regulations and standards have been identified, it is important to contact a Notified Body (NB) in the country where the certification will take place. Keep in mind that not all NB may certificate this product, only those who have the resources to spend the UNE 166: 2001. You can find the list of NBs of each EU country here.

NB will be important support throughout the process. We have done this process with:

CENTRO NACIONAL DE MEDIOS DE PROTECCIÓN - INSTITUTO NACIONAL DE SEGURIDAD E HIGIENE EN EL TRABAJO

Carabela La Niña, 16 - 41007 SEVILLA

Phone : +34 954.51.41.11

Email: cnmp@insst.mitramiss.es

Website : www.insst.es - www.insst.es/epi

There are some important points to emphasize that are basic to know before starting the certification process:

  • The standard sets the minimum height of the frame is 10 mm wide part that is in contact with the head.

  • It is important to review the material on the screen. The materials traditionally used in the manufacture of the visors of face protection screens (PPE) are polycarbonate and cellulose acetate, but they are not the only ones. It is recommended to consult a specialist for the selection of a material with the necessary optical quality since basic materials used in stationery and food do not meet the light diffusion requirements. Examples of unsatisfactory results: Monopet 450 µ, PVC 200 µ, PVC 180 µ, Acetate (180-240) µ. If you have the datasheet of the material, there is a very important parameter: HAZE, this should not be higher than 2. However, this does not ensure a positive result in the tests, but a first approach to the correct material for the screen. We have used 0,5mm thick PETG.

  • The vertical dimension of the screen should not be less than 150mm and it is recommended that it not exceed 220mm.

  • Quantities to be delivered to the NB to carry out the tests:

    Equipment Standard Quantities
    Face Shield UNE 166:2001 22 units
    Face shield Covid-19 UNE 166:2001 - RfU 03.031 11 units
  • It is important to know that if the design has sizes, the models of the different sizes have to be delivered to the NB. A reference size must be taken and an estimated 7 units from the other sizes.

    - 11 units for size M (reference)
    - 7 units for size S
    - 7 units for size L

Once these requirements have been analyzed, the samples should be sent to the NB and awaited the results.

If the results are favorable, you can request the opening of an EU (CE) type certification file and obtain a certificate with a maximum validity of 5 years from the date of issue for the 166: 2002 standard.

If you decide on option 166.2002 RfU 03.031 (Covid-19), you must request the opening of an EU type certification file, in this case the certificate will have a maximum validity until March 30, 2021. It may be that this date is lengthened as a result of the second waves of Covid-19 that are being experienced in Europe.

On this website, you will find all the documentation to pass the CE marking.

Information on the certification process is quite difficult to find. We have created these guidelines to help you take the first steps to begin this process. You have to know that each company must pass its certification process and that this process is not scalable, even if the models downloaded from this platform are printed.

How to obtain a CE mark for FaceShields?

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PPE legislation in Europe

All personal protective equipment needs to be certified and this is why we try to help in others certification processes. In the following list you can find specific notified bodies of every UE country.
Country Name UE Notified Bodies
Italy A.N.C.I. - SERVIZI S.R.L. - SEZIONE CIMAC (CENTRO ITALIANO MATERIALI APPLICAZIONE CALZATURIERA) More info
Spain AENOR INTERNACIONAL, S.A. (Unipersonal) More info
France AFNOR Certification More info
France ALIENOR CERTIFICATION More info
Austria ALLGEMEINE UNFALLVERSICHERUNGSANSTALT - SICHERHEITSTECHNISCHE PRÜFSTELLE More info
Italy ANCCP Certification Agency Srl More info
France APAVE SUDEUROPE SAS More info
Spain ASOCIACION DE INVESTIGACION DE LA INDUSTRIA TEXTIL More info
Spain ASOCIACIÓN PARA LA PROMOCIÓN, INVESTIGACIÓN, DESARROLLO E INNOVACIÓN TECNOLÓGICA DE LA INDUSTRIA DEL CALZADO Y CONEXAS DE LA RIOJA More info
France ASQUAL More info
Portugal ASSOCIAÇÃO PORTUGUESA DOS INDUSTRIAIS DO CALÇADO, COMPONENTES, ARTIGOS DE PELE E SEUS SUCEDÂNEOS More info
Hungary BIMEO VIZSGALO ES KUTATO-FEJLESZTO KFT. More info
United Kingdom BSI Assurance UK Ltd More info
Netherlands BSI Group The Netherlands B.V. More info
Germany Bureau Veritas Consumer Products Services Germany GmbH More info
Ireland CCQS Certification Services Limited More info
United Kingdom CCQS UK LTD More info
Belgium CENTEXBEL (WETENSCHAPPELIJK EN TECHNISCH CENTRUM VAN DE BELGISCHE TEXTIELNIJVERHEID - DIVISIE GENT) More info
Poland CENTRALNY INSTYTUT OCHRONY PRACY - PANSTWOWY INSTYTUT BADAWCZY (CIOP-PIB) More info
Spain CENTRO NACIONAL DE MEDIOS DE PROTECCION-INSTITUTO NACIONAL DE SEGURIDAD E HIGIENE EN EL TRABAJO More info
Italy CENTRO TESSILE COTONIERO E ABBIGLIAMENTO SPA More info
Italy CERTOTTICA SCARL More info
Portugal CITEVE Certificação Unipessoal Lda More info
Italy CSI SPA More info
France CTC More info
Germany DEKRA Testing and Certification GmbH More info
Germany DGUV Test Prüf- und Zertifizierungsstelle Elektrotechnik Fachbereich Energie Textil Elektro Medienerzeugnisse der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV) More info
Germany DGUV Test Prüf- und Zertifizierungsstelle Fachbereich Persönliche Schutzausrüstungen der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV) More info
Germany DGUV Test Prüf- und Zertifizierungsstelle Fachbereich Rohstoffe und chemische Industrie der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV) More info
Germany DGUV Test Prüf- und Zertifizierungsstelle Nahrungsmittel und Verpackung Fachbereich Nahrungsmittel der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV) More info
Germany DIN CERTCO GESELLSCHAFT FÜR KONFORMITÄTSBEWERTUNG MBH More info
Germany DNV GL SE More info
Italy DOLOMITICERT S.C.A.R.L. More info
Lithuania Department of Textiles Physical-Chemical Testing of Textile Institute of State Scientific Research Institute Center for Physical Sciences and Technology More info
Germany Deutsche Prüf- und Zertifizierungsstelle für Land- und Forsttechnik More info
Germany ECS European Certification Service GmbH More info
Spain EUROFINS TEXTILE TESTING SPAIN, S.L.U. More info
Croatia EUROINSPEKT EUROTEXTIL d.o.o. Odjel za certifikaciju More info
Italy Eurofins Product Testing Italy S.r.l. More info
France FINANCIERE POURQUERY More info
United Kingdom FLEETWOOD TEST HOUSE, BLACKPOOL AND THE FYLDE COLLEGE More info
Denmark FORCE Certification A/S More info
Hungary GÉPTESZT Termelőeszközöket Felülvizsgáló és Karbantartó Kft. More info
Germany HOHENSTEIN LABORATORIES GmbH & Co. KG More info
Austria IBS - Institut für Brandschutztechnik und Sicherheitsforschung GmbH More info
Spain IDIADA AUTOMOTIVE TECHNOLOGY S.A. More info
Hungary INNOVATEXT Textile Engineering and Testing Institute Co. More info
Netherlands INSPEC International B.V. More info
United Kingdom INSPEC International Ltd. More info
Spain INSTITUO ESPAÑOL DEL CALZADO Y CONEXAS, ASOCIACION DE INVESTIGACION More info
France INSTITUT DE RADIOPROTECTION ET DE SÛRETÉ NUCLÉAIRE More info
France INSTITUT NATIONAL DE LA PLONGEE PROFESSIONNELLE More info
Czech Republic INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. More info
Slovenia INSTITUTE OF OCCUPATIONAL SAFETY More info
Poland INSTYTUT TECHNOLOGII BEZPIECZENSTWA MORATEX More info
Italy INTERTEK Italia S.p.A. More info
Italy ISET Srl Unipersonale More info
Italy ISTITUTO ITALIANO SICUREZZA DEI GIOCATTOLI SRL More info
Italy ITALCERT SRL More info
United Kingdom ITS Testing Services (UK) Ltd More info
France Institut Français de Textile et de l'Habillement (IFTH) More info
Germany Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA) Prüf- und Zertifizierungsstelle im DGUV Test More info
Romania Institutul National de Cercetare Dezvoltare pentru Protectia Muncii - I.N.C.D.P.M. "Alexandru Darabont" More info
Romania Institutul National de Cercetare-Dezvoltare pentru Securitate Miniera si Protectie Antiexploziva More info
Poland Instytut Technologii Tekstylnych CERTEX Sp. z o.o More info
Greece KR HELLAS LTD. More info
Spain LEITAT Technological Center - Acondicionamiento Tarrasense More info
Spain LGAI TECHNOLOGICAL CENTER, S. A./Applus More info
Hungary MADI es TARSA Technical, Safety and Service Ltd. Testing Laboratory More info
Germany MATERIALPRÜFUNGSANSTALT UNIVERSITÄT STUTTGART More info
Croatia MIRTA-KONTROL d.o.o. More info
Turkey MNA LABORATUVARLARI SANAYI TICARET LIMITED ŞIRKETI More info
Italy MTIC InterCert S.r.l. More info
Switzerland (MRA) NSBIV AG (Zertifizierungsstelle SIBE Schweiz) More info
Germany PFI - PRÜF-UND FORSCHUNGSINSTITUT PIRMASENS E.V. More info
Poland POLSKI REJESTR STATKOW S.A. More info
Germany PZT GmbH More info
Italy RICOTEST More info
Italy RINA Services S.P.A. More info
Sweden RISE Research Institutes of Sweden AB More info
Sweden RISE SMP SVENSK MASKINPROVNING AB More info
Hungary SAFETY AUDIT Minőségellenőrző és Tanúsító Kft. More info
United Kingdom SATRA More info
Finland SGS FIMKO OY More info
United Kingdom SGS United Kingdom Limited More info
Poland SIEC BADAWCZA LUKASIEWICZ - INSTYTUT PRZEMYSLU SKORZANEGO More info
Poland SIEC BADAWCZA ŁUKASIEWICZ - INSTYTUT WLOKIENNICTWA More info
United Kingdom SIRA CERTIFICATION SERVICE More info
Czech Republic STROJIRENSKY ZKUSEBNI USTAV s.p. More info
United Kingdom Shirley Technologies Limited, trading as BTTG More info
Switzerland (MRA) Suva CERTIFICATION More info
Germany Sächsisches Textilforschungsinstitut e. V. - An-Institut der Technischen Universität Chemnitz More info
Denmark TEKNOLOGISK INSTITUT - Certificering & Inspektion More info
Switzerland (MRA) TESTEX AG , Schweizer Textilprüfinstitut More info
Czech Republic TEXTILNÍ ZKUŠEBNÍ ÚSTAV, s.p. More info
Turkey TURKISH STANDARDS INSTITUTION (TSE) More info
Netherlands Telefication B.V. also trading under the names Kiwa Telefication and Kiwa EMC More info
Austria TÜV AUSTRIA SERVICES GMBH More info
Germany TÜV Rheinland LGA Products GmbH More info
Netherlands TÜV Rheinland Nederland B.V. More info
Germany TÜV SÜD Product Service GmbH Zertifizierstellen More info
United Kingdom UL INTERNATIONAL (UK) LTD More info
Netherlands UL International (Netherlands) B.V. More info
Germany UNIVERSITÄT STUTTGART INSTITUT FÜR FÖRDERTECHNIK UND LOGISTIK More info
Turkey Universal Certification and Surveillance Service Trade Ltd. Co. More info
Slovakia VIPO a. s. More info
Slovakia VUTCH - CHEMITEX spol. s r.o. More info
Czech Republic VVUU, a.s. More info
Belgium Vias Institute More info
Czech Republic Vojenský technický ústav, s. p. More info
Czech Republic Vyzkumny ustav bezpecnosti prace, v. v. i. More info
Ireland satra Technology Europe Ltd More info
Austria ÖTI - Institut für Ökologie, Technik und Innovation GmbH More info
Germany Öffentliche Prüfstelle für das Textilwesen der Hochschule Niederrhein GmbH More info