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
|
SurgicalEN 14683 Type I - low EFB Type II - medium EFB TYPE IIR - medium EFB |
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.
Link to UK information on the requirements for PPE, face coverings and hand sanitising products, including fast-track approvals: click here.
Link to WHO (World Health Organization ) guidelines on mask use: click here.
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 |
|
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 or in the PPE legislation in Europe section of this website.
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?
First of all, it is necessary to contact the notified body in your country, you will find this information on this webpage. No matter which institute you choose, there is usually a section dedicated to personal protective equipment on its website.
Once all the tests have positive results, you are ready to ask for a CE. For this, it will be necessary to collect the documentation product. It is not a difficult task, but you have to be very careful and detailed in preparing the documentation.
Following you can find a list of the documents you may need.
List of documents to deliver for EU certificate:
Name and address of the manufacturer |
The number of this norm |
Protector model identification – marking (more information below) |
Instructions for storage, use and maintenance |
Drawings and diagrams of the design and manufacture of PPE and its components, sub-assemblies and circuits |
Specific instructions regarding cleaning and disinfection |
Details regarding the fields of use, level of protection and benefits |
Details regarding appropriate accessories and spare parts. Assembly instructions will be included with the original eye protector and / or accessories and loose parts |
Use-by date or duration until decommissioning, if applicable, applicable to the complete protector and / or individual parts |
Type of packaging suitable for transport, if applicable |
Meaning of the markings on the frame and eyepiece |
Warning stating that eyepieces belonging to optical class 3 should not be used for long periods of time, if applicable |
Warning regarding the compatibility of markings |
Warning indicating that materials that come into contact with the user’s skin may cause allergies in sensitive individuals |
Risk that the PPE must protect according to its design |
Name, address and identification number of the notified body or bodies that participated in the conformity assessment of the PPE |
Internet address where the declaration of conformity can be accessed |
Description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications; (quality control of filament, storage…) |
In the case of PPE produced as an individual unit to fit a specific user, all the necessary instructions for the manufacture of this type of PPE according to the approved base model |
MARKING
Marking is an important detail during the CE examination. It contains a combination of numbers and letters. Each letter/number has a certain meaning in relation to the properties of the shield. This marking could be placed in the visor or in the headband.
MARKING : European Standard + area of application + CE
Example: 166 4F CE.
- 166 corresponds to the European standard
- Number corresponding to the Field of use
FIELD OF USE
Symbol | Designation | Description of the field of use |
No symbol | Basic use | Unspecified mechanical hazards and hazards arising from ultraviolet, visible, infra-red and solar radiation |
3 | Liquids | Liquids (droplets or splashes) |
4 | Large dust particles | Dust with a particle size > 5 µm |
5 | Gas and fine dust particles | Gases, vapours, sprays, smoke and dust with a particle size < 5 µm |
8 | Short circuit electric arc | Electrical arc due to a short circuit in electrical equipment |
9 | Molten metals and hot solids | Splashes of molten metal and penetration of hot solids |
- Letter corresponds to Mechanical Resistance
PROTECTION AGAINST HIGH SPEED PARTICLES
Mechanical Resistance | Impact Level | Maximum speed | Diameter |
A | High energy impact | 190 m/s | ø 6 mm |
B | Medium energy impact | 120 m/s | ø 6 mm |
F | Low energy impact | 45 m/s | ø 6 mm |
S | Increased robustness | 5,1 m/s | ø 22 mm |
- CE is the marking of conformity with the relevant requirements
Normally, the protection against SARS-CoV-2 es 166(Standard)3(Liquids protection)S(Increased robustness)CE.
This information could also be provided by the Notified Body.
PPE legislation in Europe
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 |