2016/425 - 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 Harmonized Directive
Regulation (EU) 2016/425 governs the design, manufacture, and market placement of personal protective equipment (PPE) within the European Union, replacing Directive 89/686/EEC to enhance clarity, uniformity, and safety standards. It applies to new PPE introduced to the EU market by manufacturers established in the Union or importers from third countries, including provisions for supply via all channels such as distance selling. The regulation delineates responsibilities clearly among economic operators-manufacturers, importers, distributors-to ensure compliance with essential health and safety requirements. It mandates conformity assessment procedures to underpin CE marking, ensuring PPE meets stringent safety benchmarks. The regulation aligns with broader EU legislations related to accreditation, market surveillance, and standardisation, fostering consistent application and fairness in the internal market. It also expands the scope of PPE covered, refines technical requirements based on practical experience, and strengthens market surveillance and safeguard mechanisms to promptly identify and address non-compliant or risky PPE. This comprehensive framework aims to guarantee a high level of user protection and facilitate the free movement of compliant PPE across Member States.
Purpose
Regulation (EU) 2016/425 governs the design, manufacture, and marketing of personal protective equipment (PPE) within the European Union. It replaces Directive 89/686/EEC to address noted inadequacies and inconsistencies in product coverage and conformity assessment procedures under the former directive. The regulation aims to ensure a high level of health and safety protection for users of PPE, create a harmonized legal framework, remove trade barriers within the internal market, and provide clear obligations for economic operators. It also seeks to improve market surveillance and streamline the conformity assessment process using updated standards and procedures.
Key Obligations
Manufacturer Responsibilities: Manufacturers must ensure PPE complies with all requirements of the Regulation. They are responsible for conformity assessment, making technical documentation, and providing the EU declaration of conformity. If an economic operator places PPE on the market under their own name or modifies it potentially affecting compliance, they assume manufacturer obligations.
Importer Responsibilities: Importers must verify that PPE complies with the Regulation, ensure conformity assessment has been performed, keep relevant documentation available for authorities, and mark PPE with their name and address unless this is physically impossible.
Distributor Responsibilities: Distributors must ensure that PPE is compliant, stored and handled in a way that does not compromise conformity, and cooperate with market surveillance authorities by providing relevant information.
Conformity Assessment: PPE is categorized into three classes with specific conformity assessment procedures based on risk level. Assessment must be conducted by notified bodies or, where appropriate, by manufacturers themselves. EU type-examination certificates have a maximum validity of five years, with provisions for renewal.
CE Marking and Documentation: PPE must carry the CE marking to indicate conformity, accompanied either by a copy or internet address where the EU declaration of conformity can be accessed. Instructions and information must be clear, comprehensible, and accompany each smallest commercially available unit.
Traceability: Economic operators must keep sufficient information to identify suppliers and recipients throughout the supply chain to aid market surveillance.
Market Surveillance & Safeguard Procedures: Member States must ensure effective market surveillance to prevent non-compliant PPE entering the market. Authorities have access to technical documentation and declarations. An improved safeguard procedure is in place to handle PPE presenting a risk to health or safety.
Notified Bodies: Bodies performing conformity assessment must meet strict competence requirements and are subject to coordination, evaluation, and monitoring by Member States and the Commission. Subcontractors and subsidiaries involved in conformity assessment must comply with the same requirements.
Affected Products and Actors
Products Covered: All types of personal protective equipment-including PPE for professional and private use that protects users against health and safety risks-are covered when placed on the EU market as new products or imported from third countries.
Excluded Products: Items not claiming a protective function, such as artisanal decorative products, clothing for design or decoration purposes, or seasonal clothing that protects against non-extreme weather, are excluded. Products covered by other legislation are also excluded.
Economic Operators: Manufacturers, importers, distributors, and any operator placing PPE under their name or trademark are directly affected and bear responsibilities to ensure compliance with the Regulation.
Implementation Timeline
Regulation (EU) 2016/425 applied from 21 April 2018, replacing Directive 89/686/EEC.
Manufacturers and other economic operators had to comply with the new requirements, including updated conformity assessment and CE marking rules, from the date of application.
EU type-examination certificates issued under previous legislation remain valid for a limited time, subject to renewal conditions.
Market surveillance authorities and notified bodies adapted their procedures to the Regulation’s provisions following its entry into force.
This Regulation represents a mandatory, uniform legal framework directly applicable in all Member States, without the need for transposition into national law.
The Regulation (EU) 2016/425 applies to personal protective equipment (PPE) that is new to the Union market, whether manufactured within the Union or imported from third countries, including second-hand PPE. It covers all forms of supply, including distance selling. The scope includes PPE that protects users against health and safety risks, such as professional and private use protection against heat, but excludes decorative or design clothing without protective function, seasonal clothing, umbrellas, and dishwashing gloves. Products covered by other legislation or those that do not claim a protective function are excluded. The Regulation ensures harmonised health and safety requirements and conformity assessment procedures across the EU market, promoting free movement and providing a clear framework for manufacturers, importers, distributors, and market surveillance authorities involved in the supply chain of PPE.
Die Verordnung (EU) 2016/425 regelt persönliche Schutzausrüstungen (PSA) innerhalb der EU und ersetzt die Richtlinie 89/686/EWG durch eine Verordnung, um eine einheitliche Anwendung ohne nationale Abweichungen sicherzustellen. Ziel ist ein hohes Schutzniveau für Nutzer durch harmonisierte Anforderungen an Konformität, Sicherheit und Gesundheitsschutz. Die Verordnung definiert klare Pflichten für Hersteller, Einführer und Händler entlang der Lieferkette und legt umfassende Konformitätsbewertungsverfahren fest, die von zuständigen Stellen bewertet und überwacht werden. Sie umfasst auch Regelungen zur CE-Kennzeichnung und verpflichtet zur vollständigen Dokumentation technischer Unterlagen. Zudem werden Marktüberwachungsmaßnahmen und Rückverfolgbarkeitspflichten gestärkt. Die Verordnung behandelt auch PSA für den privaten Gebrauch gegen Hitze und schließt bestimmte Produkte vom Anwendungsbereich aus, die keinen Schutzzweck erfüllen. Ziel ist die Sicherstellung eines hohen Sicherheitsstandards, die Verbesserung der Markttransparenz und der Verbraucherschutz sowie die Harmonisierung der Regeln für PSA im Binnenmarkt.
Zweck
Die Verordnung (EU) 2016/425 regelt das Inverkehrbringen und die Bereitstellung von Persönlicher Schutzausrüstung (PSA) in der Europäischen Union. Sie ersetzt die Richtlinie 89/686/EWG und verfolgt das Ziel, einen einheitlichen, hohen Gesundheits- und Sicherheitsstandard bei PSA sicherzustellen sowie Handelshemmnisse im Binnenmarkt abzubauen. Die Verordnung präzisiert den Rechtsrahmen für PSA, um Mängel und Unstimmigkeiten bei Produkten und Konformitätsbewertungsverfahren zu beheben. Als Verordnung ist sie unmittelbar in allen Mitgliedstaaten anwendbar, wodurch eine einheitliche Umsetzung ohne Spielräume für divergierende nationale Regelungen gewährleistet wird.
Wichtige Verpflichtungen
Herstellerpflichten: Hersteller sind verantwortlich für die Durchführung der Konformitätsbewertungsverfahren ihrer PSA. Sie müssen sicherstellen, dass die Produkte den grundlegenden Gesundheits- und Sicherheitsanforderungen entsprechen, eine EU-Konformitätserklärung erstellen und die CE-Kennzeichnung anbringen.
Einführerpflichten: Einführer aus Drittländern müssen sicherstellen, dass PSA die Anforderungen der Verordnung erfüllen, dass Konformitätsbewertungsverfahren durchgeführt wurden und technische Unterlagen für Marktüberwachungszwecke vorliegen. Sie müssen ihre Kontaktdaten auf der PSA angeben.
Händlerpflichten: Händler müssen mit angemessener Sorgfalt prüfen, dass PSA die Konformitätsanforderungen erfüllen und dürfen keine nicht-konformen Produkte bereitstellen.
Verpflichtungen zur Rückverfolgbarkeit: Alle Wirtschaftsakteure müssen gewährleisten, dass PSA über die gesamte Lieferkette rückverfolgbar sind. Eine verpflichtende Dokumentation dient der Unterstützung der Marktüberwachungsbehörden.
Anforderungen an Konformitätsbewertungsstellen: Notifizierte Stellen müssen einheitliche Qualitäts- und Leistungsstandards erfüllen. Sie dürfen Teile ihrer Aufgaben an Unterauftragnehmer oder Zweigstellen nur vergeben, wenn diese die gleichen Anforderungen erfüllen.
Marktüberwachung: Nationale Behörden überwachen den Markt und erhalten Zugang zu den EU-Konformitätserklärungen sowie den technischen Unterlagen. Wirtschaftsakteure sind verpflichtet, aktiv bei der Marktüberwachung mitzuwirken.
CE-Kennzeichnung: Die Verordnung enthält spezifische Vorschriften zur Anbringung der CE-Kennzeichnung, die als sichtbares Zeichen der Konformität dient.
Betroffene Produkte und Akteure
Produkte: Die Verordnung gilt für persönliche Schutzausrüstungen, die neu in der EU in Verkehr gebracht werden, sei es durch Hersteller in der Union oder durch Einfuhr aus Drittländern. PSA umfasst Ausrüstung, die Personen vor gesundheitlichen oder sicherheitsrelevanten Risiken schützt.
Ausgeschlossen sind: Produkte, die lediglich modischen oder dekorativen Zwecken dienen, nicht als PSA definiert sind oder durch andere Rechtsvorschriften geregelt werden (z. B. wetterfeste Kleidung ohne spezifische Schutzfunktion).
Akteure: Hersteller, Einführer, Händler sowie Konformitätsbewertungsstellen. Wirtschaftsbeteiligte, die PSA unter ihrem eigenen Namen in Verkehr bringen oder Produkte wesentlich verändern, gelten ebenfalls als Hersteller.
Umsetzungszeitplan
Die Verordnung wurde am 9. März 2016 angenommen und ersetzt die bisherige Richtlinie 89/686/EWG.
Mitgliedstaaten und Wirtschaftsakteure hatten eine Übergangsfrist zur Umsetzung der neuen Anforderungen, insbesondere um die direkten Vorgaben der Verordnung zu erfüllen.
Die EU-Konformitätserklärungen, technischen Unterlagen und CE-Kennzeichnungen müssen seit Inkrafttreten den neuen Vorgaben entsprechen. Hersteller und Konformitätsbewertungsstellen müssen ihre Verfahren anpassen, um die Gültigkeitsdauer der EU-Baumusterprüfbescheinigung (maximal 5 Jahre) einzuhalten.
Die Mitgliedstaaten müssen sicherstellen, dass ihre Marktüberwachungsbehörden effizient arbeiten und mit den Wirtschaftsakteuren zusammenarbeiten.
Diese Verordnung modernisiert und harmonisiert die Regulierung persönlicher Schutzausrüstung in der EU umfassend, um ein hohes Schutzniveau sowie einen fairen Binnenmarkt sicherzustellen.
Die Verordnung (EU) 2016/425 gilt für persönliche Schutzausrüstungen (PSA), die neu in den Markt der Europäischen Union eingeführt werden. Dies umfasst sowohl neue PSA, die von Herstellern innerhalb der Union erzeugt werden, als auch neue oder gebrauchte PSA, die aus Drittländern eingeführt werden. Die Verordnung bezieht sich auf PSA für berufliche und private Nutzung, die einen Schutz des Nutzers bieten, wie etwa Schutzkleidung gegen Hitze. Ausgeschlossen sind unter anderem handwerklich hergestellte Produkte ohne Schutzfunktion sowie für den privaten Gebrauch bestimmte Kleidung mit reflektierenden oder fluoreszierenden Elementen aus modischen Gründen, ebenso wie Produkte gegen leichte Witterungseinflüsse wie Regenschirme oder Spülhandschuhe. Die Verordnung gilt für sämtliche Vertriebsformen, einschließlich des Fernabsatzes, und stellt sicher, dass alle PSA, die auf den Markt gebracht werden, einheitlichen Gesundheits- und Sicherheitsanforderungen entsprechen.
Le règlement (UE) 2016/425 établit un cadre strict pour les équipements de protection individuelle (EPI) afin d'assurer la santé et la sécurité des utilisateurs sur le marché européen. Il remplace la directive 89/686/CEE, harmonisant les exigences techniques et les procédures d’évaluation de conformité pour tous les États membres via un règlement, garantissant ainsi une application uniforme. Le texte définit clairement les responsabilités des fabricants, importateurs, distributeurs et autres opérateurs économiques, insiste sur la traçabilité des EPI tout au long de la chaîne d’approvisionnement, et impose des procédures d’évaluation adaptées aux catégories de risques des équipements. Le règlement étend son champ d’application aux EPI à usage privé contre la chaleur et précise les exclusions concernant certains produits. Il fixe des exigences pour les organismes d’évaluation de conformité, intégrant la norme d’accréditation afin d’assurer un niveau homogène et élevé de qualité dans les contrôles. Le marquage CE, élément central attestant la conformité, est également réglementé pour garantir la sécurité et la libre circulation des EPI au sein de l’Union.
Objet
Le Règlement (UE) 2016/425 du Parlement européen et du Conseil du 9 mars 2016 établit des règles harmonisées relatives aux équipements de protection individuelle (EPI). Il a pour but de garantir un niveau élevé de protection de la santé et de la sécurité des utilisateurs d’EPI dans l’Union européenne, ainsi que de favoriser la libre circulation de ces équipements au sein du marché intérieur. Ce règlement remplace la directive 89/686/CEE, en raison des incohérences et insuffisances constatées, en imposant un cadre réglementaire plus clair et uniforme, notamment par le passage d’une directive à un règlement.
Obligations principales
Fabricants : Doivent effectuer la procédure d’évaluation de la conformité de leurs EPI selon les exigences essentielles de santé et de sécurité fixées par le règlement. Ils doivent fournir une documentation technique complète, une déclaration UE de conformité, et apposer le marquage CE. En cas de mise sur le marché sous leur nom ou marque propre, ou de modification affectant la conformité, ils deviennent responsables comme fabricant.
Importateurs : Sont responsables de veiller à ce que les EPI importés respectent les exigences du règlement. Ils doivent s’assurer que les procédures de conformité ont été correctement effectuées, que le marquage CE est apposé et que la documentation est disponible pour les autorités compétentes. Ils doivent identifier l’EPI par leur nom ou marque et leur adresse sauf impossibilité technique.
Distributeurs : Doivent s’assurer que les EPI mis à disposition ne portent pas atteinte à leur conformité. Ils sont aussi associés à la surveillance du marché par les autorités compétentes.
Tous les opérateurs économiques : Ont l’obligation de ne mettre sur le marché que des EPI conformes au règlement. Ils doivent conserver les informations permettant de garantir la traçabilité des EPI tout au long de la chaîne d’approvisionnement afin de faciliter la surveillance du marché.
Organismes d’évaluation de la conformité : Leur compétence doit être attestée soit par accréditation, soit par une évaluation des autorités nationales compétentes. Ils doivent garantir un niveau équivalent de qualité et de concurrence loyale dans toute l’Union.
Produits et acteurs concernés
Le règlement s’applique aux équipements de protection individuelle neufs ou d’occasion, produits par un fabricant établi dans l’Union ou importés de pays tiers, destinés à protéger l’utilisateur contre un ou plusieurs risques susceptibles de menacer la santé ou la sécurité.
Sont inclus les EPI à usage privé contre la chaleur, ainsi que les EPI similaires à usage professionnel. Sont exclus notamment les vêtements décoratifs sans fonction protectrice, les vêtements saisonniers, les parapluies, gants de vaisselle, et d’autres produits relevant d’autres législations.
Les acteurs concernés comprennent les fabricants, importateurs, distributeurs, organismes d’évaluation de la conformité, autorités nationales de surveillance du marché et, indirectement, les utilisateurs finaux.
Calendrier de mise en œuvre
Le règlement est directement applicable dans tous les États membres de l’Union européenne sans nécessité de transposition en droit national.
La durée de validité des attestations d'examen UE de type est limitée à un maximum de cinq ans, avec une procédure de réexamen prévue.
Les normes harmonisées produites par le Comité européen de normalisation (CEN et CENELEC) sont utilisées comme base pour la présomption de conformité.
La surveillance du marché doit être active dès la mise en application du règlement, impliquant la conservation des documents techniques et la coopération entre les opérateurs économiques et autorités nationales.
Les règles à propos du marquage CE, des procédures d’évaluation de la conformité et des obligations des opérateurs économiques sont applicables dès la publication du règlement, avec un renforcement progressif des contrôles et de la traçabilité.
Le règlement (UE) 2016/425 s'applique aux équipements de protection individuelle (EPI) qui sont nouveaux pour le marché de l'Union européenne lors de leur mise à disposition, qu'ils soient fabriqués dans l'Union ou importés de pays tiers, neufs ou d'occasion. Il couvre toutes les formes de fourniture, y compris la vente à distance. Sont visés les EPI destinés à protéger l'utilisateur contre les risques susceptibles de menacer sa santé ou sa sécurité dans divers secteurs professionnels ou pour un usage privé contre certains risques spécifiques, comme la chaleur. Toutefois, certains produits sont exclus, notamment les vêtements et accessoires à usage privé ne répondant pas à une véritable fonction de protection (vêtements de saison, parapluies, gants de vaisselle), ainsi que ceux relevant d'autres législations sectorielles spécifiques. L'objectif est d'assurer un haut niveau de protection homogène dans tous les États membres tout en facilitant la libre circulation des EPI conformes sur le marché intérieur.
Uredba (EU) 2016/425 ureja trženje osebne varovalne opreme (OVO) na notranjem trgu EU in nadomešča Direktivio 89/686/EGS. Namen uredbe je zagotoviti visoko raven varstva zdravja in varnosti uporabnikov OVO ter odstraniti trgovinske ovire z uvajanjem enotnih zahtev glede proizvodnje, skladnosti, označevanja in nadzora teh izdelkov. Uredba določa jasne zahteve za gospodarske subjekte, kot so proizvajalci, uvozniki in distributerji, glede zagotavljanja skladnosti OVO z bistvenimi zdravstvenimi in varnostnimi zahtevami ter obveznosti glede dokumentacije in sledljivosti. Poudarja pomembnost harmoniziranih standardov in postopkov ugotavljanja skladnosti, ki jih izvajajo priglašeni organi, ter uvaja mehanizme za nadzor trga in ukrepe v primeru neskladnosti. Uredba se uporablja za vse vrste ponudbe OVO, vključno s prodajo na daljavo, in določa, da morajo tudi izdelki iz tretjih držav izpolnjevati enake zahteve. Cilj je poenostavitev pravnega okvira, povečanje varnosti uporabnikov ter pošteno konkurenco na trgu OVO v EU.
Namen
Uredba (EU) 2016/425 ureja osebno varovalno opremo (OVO) v EU z namenom zagotavljanja visokih zdravstvenih in varnostnih standardov na notranjem trgu. Nadomešča Direktivo 89/686/EGS in postavlja jasna, usklajena pravila za izdelavo, dajanje na trg in nadzor osebne varovalne opreme, ki jo je treba uporabiti za zaščito uporabnikov pred nevarnostmi. Cilj je odstraniti ovire pri trgovanju med državami članicami, izboljšati skladnost izdelkov ter zagotoviti varnost in zaščito potrošnikov in uporabnikov OVO.
Ključne obveznosti
- Proizvajalci so odgovorni za zagotovitev skladnosti OVO z zahtevanimi bistvenimi zdravstvenimi in varnostnimi zahtevami, kar mora dokazovati s postopki ugotavljanja skladnosti. Proizvajalec mora zagotoviti tehnično dokumentacijo in izjavo EU o skladnosti, ki mora spremljati izdelek.
- Uvozniki morajo zagotavljati, da OVO iz tretjih držav izpolnjuje zahteve uredbe, in da so postopki ugotavljanja skladnosti zapolnjeni. Prav tako morajo na OVO navesti svoje identifikacijske podatke in zagotoviti, da so na voljo organom nadzora.
- Distributerji morajo delovati skrbno, da njihovo posredovanje ne vpliva na skladnost OVO in morajo sprejeti ukrepe, da na trg ne pride neskladna oprema.
- Vsak gospodarski subjekt, ki da OVO na trg pod svojim imenom ali blagovno znamko ali ga spremeni na način, ki vpliva na skladnost, se šteje za proizvajalca in nosi njegove obveznosti.
- Države članice morajo vzpostaviti nadzor trga, spremljati skladnost OVO in ukrepati v primeru tveganja za zdravje ali varnost uporabnikov.
- Priglašeni organi morajo imeti ustrezno usposobljenost ter opravljati postopke ugotavljanja skladnosti na enotnem visoko kakovostnem nivoju.
- Oznaka CE mora biti jasno nameščena na osebno varovalno opremo kot znak skladnosti z uredbo.
Zajeti izdelki in upravičenci
- Osebna varovalna oprema vključuje izdelke, ki jih uporabniki nosijo za zaščito pred nevarnostmi, kot so fizični, kemični, biološki ali drugi dejavniki.
- Uredba zajema tako novo OVO, proizvedeno v EU, kot novo ali rabljeno OVO, uvoženo iz tretjih držav.
- Izključena oprema so npr. oblačila za zasebno rabo brez zaščitnih funkcij, sezonska oblačila, dežniki, in okrasni proizvodi, ki ne zagotavljajo zaščite.
- Vključena je OVO za profesionalno in zasebno rabo, tudi oprema za zaščito pred vročino.
- Uredba obravnava dobavo OVO v vseh oblikah, vključno s prodajo na daljavo.
Časovnica izvajanja
- Uredba je bila sprejeta 9. marca 2016 in nadomešča Direktivo 89/686/EGS.
- Proizvajalci, uvozniki in distributerji so morali prilagoditi svoje postopke skladno z uredbo takoj ob uveljavitvi.
- Certifikati o EU-pregledu tipa (označevanju skladnosti) imajo veljavnost največ pet let, s predvidenim postopkom za njihov pregled in podaljšanje.
- Države članice morajo uvesti potrebne nadzorne mehanizme in zagotoviti ustrezne organe za ugotavljanje skladnosti ter nadzor trga.
- Komisija ima pooblastila za spremembe uredbe, da upošteva tehnološki napredek in nove znanstvene ugotovitve.
Uredba 2016/425 s tem zagotavlja enotna in jasna pravila za vse akterje v dobavni verigi osebne varovalne opreme ter ščiti zdravje in varnost uporabnikov po vsej Evropski uniji.
Direktiva 2016/425 se uporablja za osebno varovalno opremo (OVO), ki je nova v trenutku dajanja na trg EU, vključno z opremo, izdelano v EU ali uvoženo iz tretjih držav, ter zajema vse načine dobave, tudi prodajo na daljavo. Namenjena je zagotavljanju enotnih osnovnih zdravstvenih in varnostnih zahtev za osebno varovalno opremo, ki varuje uporabnike pred tveganji, ki bi lahko ogrozila njihovo varnost ali zdravje. Direktiva zajema tako profesionalno kot zasebno varovalno opremo, pri čemer so nekateri izdelki, kot so okrasna oblačila z odsevnimi elementi, sezonska oblačila ali dežniki, izvzeti, saj zanje ni predvidena zaščitna funkcija. Območje uporabe pokriva tudi opremo, namenjeno zaščiti pred ekstremnimi vremenskimi pogoji, vibracijami, hrupom in sevanjem, s ciljem povečati raven varnosti uporabnikov in zagotoviti brezhibno delovanje trga EU.
General Information
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The protective effects and requirements of footwear, gloves and separate headwear are excluded from the scope of this document.
- Standard25 pagesEnglish languagee-Library read for1 day
This document is applicable to electrical insulating protective clothing used by skilled persons when they are working on or near live parts of low-voltage installations at nominal voltages up to 500 V AC. The purpose of this clothing is to prevent dangerous current from passing through persons when there is a risk of unintentional contact with several live parts located in and around the working area. This document does not deal with protection against the effects of an electric arc, DC applications and voltages higher than 500 AC. The products designed and manufactured according to this document contribute to the safety of the users provided they are used by skilled persons, in accordance with safe methods of work and the instructions for use.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for protective helmets for ski mountaineers intended to protect the head of the user in order to reduce the risk of impact injury.
This document is also applicable to protective helmets used in activities with similar hazards including but not limited to; ski-touring, speed-touring, ski fitness, split-boarding, skimo, telemark touring, but does not apply to protective helmets for alpine skiers and snowboarders.
- Standard31 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for protective helmets for use in mountaineering intended to protect the head of the user in order to reduce the risk of impact injury.
This document is also applicable to protective helmets used in activities with similar hazards as in mountaineering including, but not limited to, climbing, caving, canyoning, rope courses, and via ferrata climbing.
This document does not apply to protective helmets used by ski mountaineers as defined in FprEN 18100:2025 .
- Standard29 pagesEnglish languagee-Library read for1 day
This document specifies a method for assessing the heat penetration resistance of materials intended for use in clothing to protect against large splashes of molten metal. It provides specific procedures for assessing the effects of splashes of molten aluminium, molten cryolite, molten copper, molten iron and molten mild steel.
The principle of the test method is applicable to a wider range of hot molten materials than those for which specific procedures are set out, provided that appropriate measures are applied to protect the test operator. It is important to note that good resistance of a material to a pure molten metal does not guarantee a good performance against any slag that can be present in a manufacturing process.
- Standard23 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for protective gloves to protect the hairdressers especially from the risk associated with micro-organisms and dangerous chemicals and defines terms to be used.
- Standard20 pagesEnglish languagee-Library read for1 day
- Corrigendum3 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for operators' eye protectors for intense light source (ILS) equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation.
This document is applicable to devices intended for patient protection during ILS procedures, except for treatment in the periorbital area. For guidance on patient eye protection during ILS procedures, see ISO/TR 22463.
For guidance on the use and selection of ILS eye protectors, see ISO 12609-2.
This document does not apply to:
— laser protectors, for which ISO 19818-1 applies;
— protectors for medically prescribed applications (not occupational), e.g. eye protection for severe dry eye, tints prescribed for medical conditions;
— protectors specifically intended for protection against only solar radiation and used in non-occupational environments for which the ISO 12312 (all parts) applies;
— protectors used with tanning equipment;
— protectors intended to protect against ionizing radiation, e.g. X-rays, for which IEC 61331-3 applies.
- Standard22 pagesEnglish languagee-Library read for1 day
This document specifies requirements for enhanced visibility equipment in the form of garments, or devices, which are capable of visually signalling the user’s presence.
The enhanced visibility equipment is intended to provide conspicuity of the wearer in medium risk situations under any daylight conditions and/or under illumination by vehicles headlights or searchlights in the dark.
Performance requirements are included for colour and retroreflection as well as for the minimum areas and for the placement of the materials in protective equipment.
This document is not applicable to:
- high visibility equipment in high-risk situations, which is covered in EN ISO 20471 (for further information concerning risk situations, see Annex A);
- visibility equipment specifically intended for the head, hands and feet, e.g. helmets, gloves and shoes;
- equipment integrating active lighting, e.g. LEDs;
- visibility for low-risk situations.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies safety requirements and test methods for all types of load sharing devices commonly used in mountaineering (climbing and associated activities).
This document does not cover the specific requirements of devices intended for use in slackline applications.
- Standard13 pagesEnglish languagee-Library read for1 day
This document specifies safety requirements and test methods for all types of load sharing devices commonly used in mountaineering (climbing and associated activities).
This document does not cover the specific requirements of devices intended for use in slackline applications.
- Standard13 pagesEnglish languagee-Library read for1 day
This document specifies requirements for enhanced visibility equipment in the form of garments, or devices, which are capable of visually signalling the user’s presence.
The enhanced visibility equipment is intended to provide conspicuity of the wearer in medium risk situations under any daylight conditions and/or under illumination by vehicles headlights or searchlights in the dark.
Performance requirements are included for colour and retroreflection as well as for the minimum areas and for the placement of the materials in protective equipment.
This document is not applicable to:
- high visibility equipment in high-risk situations, which is covered in EN ISO 20471 (for further information concerning risk situations, see Annex A);
- visibility equipment specifically intended for the head, hands and feet, e.g. helmets, gloves and shoes;
- equipment integrating active lighting, e.g. LEDs;
- visibility for low-risk situations.
- Standard32 pagesEnglish languagee-Library read for1 day
- Amendment19 pagesEnglish languagee-Library read for1 day
This document specifies requirements for design, performance, test methods and markings for industrial protective helmets. The requirements apply to helmets for general use in industry.
Additional performance requirements for special applications are included to apply only when specifically claimed by the helmet manufacturer.
Industrial protective helmets are intended to reduce the risk of head injuries caused by impacts and therefore can reduce consequential effects.
- Standard55 pagesEnglish languagee-Library read for1 day
This document specifies requirements for design, performance, test methods and markings for industrial protective helmets. The requirements apply to helmets for general use in industry.
Additional performance requirements for special applications are included to apply only when specifically claimed by the helmet manufacturer.
Industrial protective helmets are intended to reduce the risk of head injuries caused by impacts and therefore can reduce consequential effects.
- Standard55 pagesEnglish languagee-Library read for1 day
- Amendment19 pagesEnglish languagee-Library read for1 day
This document specifies requirements for garments that support the protection against tick bites. The document applies to body covering garments (at least covering the torso, arms and legs) where protection against tick bites, which is provided by garments as physical barriers, is reinforced by industrial treatment with the biocide permethrin of the fabrics, fibres or yarns prior to confection. The specified requirements focus on prevention of bites by the nymph stage of the tick Ixodes ricinus, which is the most relevant stage and species for public and occupational health in Europe.
This document specifies requirements and the tests for garments containing permethrin to provide sufficient assistance in protection against tick bites, and to be durable and safe for the user.
NOTE 1 Non-permethrin containing garments covering the torso, arms and legs and feet offer some protection against tick bites, but are insufficient under high exposure to ticks, which can crawl over the fabric to reach bare skin and bite. Garments that comply with this document and cover at least torso, arms and legs to counter ticks from crawling over the fabric to reach bare skin and bite thereby provide substantial protection.
NOTE 2 The importance of following manufacturers laundering instructions to prevent early deterioration of the effect of permethrin treatment is stressed throughout the document.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies performance requirements and test methods for eye and face protectors for use in ice hockey only.
This document is applicable to eye and face protectors worn by ice hockey players other than goalkeepers and by referees.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies performance requirements and test methods for head and face protectors for use by ice hockey goalkeepers only.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies general requirements and test methods for head, face, eye, neck, and body protectors (hereafter referred to as protectors) for use in ice hockey.
This document is intended only for protectors used for ice hockey.
- Standard18 pagesEnglish languagee-Library read for1 day
This document specifies performance requirements and test methods for head protectors for use in ice hockey.
This document is applicable to head protectors worn by ice hockey players excluding goalkeepers and by referees.
- Standard30 pagesEnglish languagee-Library read for1 day
- Amendment6 pagesEnglish languagee-Library read for1 day
This document specifies requirements, test methods, marking, manufacturer’s instructions and information and packaging for guided type fall arresters including a flexible anchor line forming a single product. This anchor line is attached to an upper anchor point for vertical and inclined applications; for horizontal applications, the anchor point can be located at the user’s foot level. Guided type fall arresters including a flexible anchor line conforming to this document are components of one of the fall arrest systems covered by EN 363:2018. Other types of fall arresters are specified in EN 353-1:2014+A1:2017 or EN 360:2023.
- Standard42 pagesEnglish languagee-Library read for1 day
This document specifies performance requirements and test methods for eye and face protectors for use in ice hockey only.
This document is applicable to eye and face protectors worn by ice hockey players other than goalkeepers and by referees.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies performance requirements and test methods for head and face protectors for use by ice hockey goalkeepers only.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies general requirements and test methods for head, face, eye, neck, and body protectors (hereafter referred to as protectors) for use in ice hockey.
This document is intended only for protectors used for ice hockey.
- Standard18 pagesEnglish languagee-Library read for1 day
This document specifies performance requirements and test methods for head protectors for use in ice hockey.
This document is applicable to head protectors worn by ice hockey players excluding goalkeepers and by referees.
- Standard30 pagesEnglish languagee-Library read for1 day
This document specifies safety requirements and test methods for components of an individual safety system for protection against a fall from height used in permanent and mobile rope courses as defined in EN 15567-1:2015+A1:2020.
The products considered in this document are not intended to limit, by themselves, the deceleration of the fall of the user, as defined in EN 15567-1:2015+A1:2020. For this requirement, it is essential to consider the whole ropes course system.
Safety lines and harnesses are not covered in this document.
- Standard20 pagesEnglish languagee-Library read for1 day
This document specifies safety requirements and test methods for components of an individual safety system for protection against a fall from height used in permanent and mobile rope courses as defined in EN 15567-1:2015+A1:2020.
The products considered in this document are not intended to limit, by themselves, the deceleration of the fall of the user, as defined in EN 15567-1:2015+A1:2020. For this requirement, it is essential to consider the whole ropes course system.
Safety lines and harnesses are not covered in this document.
- Standard20 pagesEnglish languagee-Library read for1 day
- Amendment12 pagesEnglish languagee-Library read for1 day
This document specifies a test method for helmets that measures the translational and rotational kinematics in impacts of a helmeted headform against an anvil.
- Standard17 pagesEnglish languagee-Library read for1 day
This document specifies the test method for determining the resistance of chemical protective clothing to penetration by sprays of liquid chemicals at two different levels of intensity:
a) Method A: low-level spray test. This is applicable to clothing that covers the full body surface and is intended to be worn when there is a potential risk of exposure to small quantities of spray or accidental low-volume splashes of a liquid chemical.
b) Method B: high-level spray test. This is applicable to clothing with spray-tight connections between different parts of the clothing and, if applicable, between the clothing and other items of personal protective equipment, which covers the full body surface and which is intended to be worn when there is a risk of exposure to sprayed liquid chemical.
This document does not apply to chemical permeation resistance of the materials from which the chemical protective clothing is made.
- Standard27 pagesEnglish languagee-Library read for1 day
This document provides technical details for calculating predicted burn injury to human skin when its surface is subject to a varying heat flux, such as may occur due to energy transmitted through and by a garment or protective clothing ensemble exposed to flames. A series of test cases are provided against which the burn injury prediction calculation method is verified. It also contains requirements for the in situ calibration of the thermal energy sensor — skin injury prediction system for the range of heat fluxes that occur under garments.
The skin burn injury calculation methods as presented in this test method do not include terms for handling short wavelength radiation that may penetrate the skin. The latter include arc flashes, some types of fire exposures with liquid or solid fuels, and nuclear sources.
- Standard26 pagesEnglish languagee-Library read for1 day
This document specifies requirements on construction, design, performance, marking and user information for earplugs.
In particular, it specifies requirements regarding the sound attenuation of the earplugs, measured in accordance with EN ISO 4869-1:2018.
This document applies to earplugs designed for users who are able to follow supplied instructions and understand the related risks, can fit the earplugs correctly and can give feedback on the performance.
Ergonomic aspects are addressed by taking into account, within the requirements, the interaction between the user, the device and where possible the working environment in which the device is likely to be used (see Annex ZA and EN 458).
- Standard18 pagesEnglish languagee-Library read for1 day
This document EN 13819-1 specifies physical test methods for hearing protectors. The purpose of these tests is to enable assessment of the performance of the hearing protector as specified in the appropriate product standard.
- Standard54 pagesEnglish languagee-Library read for1 day
- Amendment6 pagesEnglish languagee-Library read for1 day
- Corrigendum1 pageEnglish languagee-Library read for1 day
This document specifies requirements, test methods, marking, manufacturer’s instructions and information and packaging for guided type fall arresters including a flexible anchor line forming a single product. This anchor line is attached to an upper anchor point for vertical and inclined applications; for horizontal applications, the anchor point can be located at the user’s foot level. Guided type fall arresters including a flexible anchor line conforming to this document are components of one of the fall arrest systems covered by EN 363:2018. Other types of fall arresters are specified in EN 353-1:2014+A1:2017 or EN 360:2023.
- Standard42 pagesEnglish languagee-Library read for1 day
This document specifies requirements for knee protectors (knee mats (type 3)) and performance levels for use when working in a kneeling position in order to reduce injuries to the knees caused by continuous pressure and penetration. Requirements for the marking of knee mats and the information to be supplied by the manufacturer are given. Where protection against additional hazards is claimed, performance requirements from other standards are applicable.
This document does not apply to knee protectors that are medical devices or are intended for sports and motorcycles.
- Standard16 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
An EU Regulation is a binding legislative act that must be applied in its entirety across the European Union. Unlike directives, regulations do not need to be transposed into national law and are directly applicable in all member states. Regulations are used when uniform application across all EU countries is essential.
Regulation 2016/425 covers "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". This legislation has harmonized European standards (hENs) that provide a presumption of conformity with its essential requirements. There are 1141 standards associated with this regulation.
Harmonized standards under 2016/425 are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 2016/425, facilitating CE marking and free movement within the European Economic Area.