CE Marking Personal Protective Equipment (PPE)
CE Marking for Personal Protective Equipment (PPE)
European Directive PPE 2016/425/UE
The European Directive PPE 2016/425/EU regulates the Equipment for Individual Protection (EPI / PPE) and harmonizes the health and safety requirements for the use of personal protection equipment that protects users at European level and for the entire Economic Area European (EEA). These products must meet all the requirements established by law before being introduced to the market, marketed or used.
The purpose of this directive is to provide users with reliable protection equipment. This must contribute significantly to reduce injuries and health damage to people who depend directly on product’s safety performance. By fixing the CE Mark on these products, the manufacturer or importer guarantees that they meet the requirements established by law in the European Union for safety, health and the environment.
Brief
1. This Regulation applies to PPE.
2. This Regulation does not apply to PPE:
(a) specifically designed for use by the armed forces or in the maintenance of law and order; (b) designed to be used for self-defence, with the exception of PPE intended for sporting activities;
(c) designed for private use to protect against: (i) atmospheric conditions that are not of an extreme nature,
(ii) damp and water during dishwashing;
(d) for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
(e) for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.
For the purposes of this Regulation, the following definitions apply:
(1) ‘personal protective equipment’ (PPE) means:
(a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;
(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;
(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;
[…]
(9) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;
[…]
Rules and conditions for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packaging and to the documents accompanying the PPE. 2. The CE marking shall be affixed before the PPE is placed on the market.
3. For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure set out in Annex VII or VIII. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
4. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.
5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
RISK CATEGORIES OF PPE
This Annex lays down the categories of risk against which PPE is intended to protect users.
Category I Category I includes exclusively the following minimal risks:
(a) superficial mechanical injury;
(b) contact with cleaning materials of weak action or prolonged contact with water;
(c) contact with hot surfaces not exceeding 50 °C;
(d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);
(e) atmospheric conditions that are not of an extreme nature.
Category II
Category II includes risks other than those listed in Categories I and III;
Category III
Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:
(a) substances and mixtures which are hazardous to health;
(b) atmospheres with oxygen deficiency;
(c) harmful biological agents;
(d) ionising radiation;
(e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;
(f) low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less;
(g) falling from a height; (h) electric shock and live working;
(i) drowning;
(j) cuts by hand-held chainsaws;
(k) high-pressure jets;
(l) bullet wounds or knife stabs;
(m) harmful noise.
- No Modifications -
¿Need assessment to perform the CE Marking to Personal Protective Equipment?
Sherpa Product Certification provides complete certification or concrete assistance at any stage and throughout the process of certification or CE Marking to Personal Protective Equipment (PPE) and products covered by the European Directive 2016/425/EC, Our intervention will summarize and delimit the legal framework that applies to your products, facilitating the identification and understanding of requirements and the development of processes to fulfill them.
How Sherpa Product Certification can help?
- Classify the product and determine the legal framework applicable in each case.
- Identify essential requirements in specific Directives by product.
- Identify, acquire, adapt to the design and carry out tests on products according to Harmonized European and Regulatory Standards.
- Check and manage the intervention of an Accredited Body (Notified Body).
- Evaluate the Product’s Conformity Evaluation according to the mandate established in the Directive.
- Prepare and maintain the technical documentation.
- Write the Declaration of Conformity and carry out the CE Marking.
How can we Help you?
- Complete European Certification and CE Marking for your products
- Complete assessment for manufacturers, importers or exporters regarding product legislation
- General inquiries about CE Marking
- Product analysis & classification in accordance with its applicable normative scheme and region
- Determine which regulations and directives apply to a product at an specific region
- Customs Tariff analysis for products and materials.
- Perform product conformity test according EN, ISO, IEC among others
- Product Market Access complete assistance
- Determine corrections and authenticity about specific Product Certifications.
- Determine manufacturer's, importer's and distributores responsabilities regarding product legislation.
- European Authorised Representatives Services
- Write and validate product's Tecnical Documentation and Declaration of Conformity
- Perform Risk Analysis
- Packaging and labeling verification according to its applicable normative
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ABOUT SHERPA
Sherpa Product Certification is formed by a group of engineers who are experts in regulation and standardization of products, materials and industrial processes at an international level. Our essence as Sherpas is to help our clients to create lasting value in their business and meet their professional needs. If you need help in the procedures of a certificate or simply need specific information about our services, we are happy to help you. Hire a Sherpa in your company and forget about legislation and documentation of your products. Our Sherpas certification experts report quickly and efficiently to the needs of our clients when we are most needed.