PERSONAL PROTECTIVE EQUIPMENT
Personal Protective Equipment is defined and evaluated equipment, tools or devices designed to provide health and safety directly or indirectly to the user.
CE marking is a sign that shows that Personal Protective Equipment (PPE) complies with the safety, health and environmental protection requirements of the European Union (EU).
The CE mark allows products to to circulate freely within the European Economic Area (EEA) and assures consumers that the product meets certain standards.
Personal Protective Equipment is defined and evaluated equipment, tools or devices designed to provide health and safety directly or indirectly to the user. Masks, overalls, reflective vests, face shields, goggles, gloves, helmets, and work shoes are some of the equipment considered within the scope of PPE.
Personal Protective Equipment (PPE) is subject to Regulation (EU) 2016/425, which defines conformity assessment procedures according to the categories and modules of the products.
“Personal Protective Equipment (PPE) is defined and evaluated as equipment, tools or devices designed to provide health and safety to its user directly or indirectly. Masks, overalls, reflective vests, visors, goggles,, gloves, helmets, work shoes are some of the equipment evaluated within the scope of PPE.
Personal Protective Equipment (PPE) is subject to Regulation (EU) 2016/425, which defines conformity assessment procedures according to the categories and modules of the products.
Personal Protective Equipment (PPE) cannot be legally marketed without a CE mark. The CE mark must be affixed to the product as proof that it has been manufactured and placed on the market safely.
Affix the CE mark on PPE produced under the Personal Protective Equipment Regulation (EU) 2016/425, manufacturers must obtain services from conformity assessment bodies.
The European Commission places utmost importance on the compliance of Personal Protective Equipment with regulatory requirements, recognizing it as a crucial component of the ‘Health and Safety at Work’ approach
The Importance of CE Marking on Personal Protective Equipment
Market Access: CE marking is mandatory for PPE to be legally sold in the EEA.
Security and Confidence: Products bearing the CE mark are manufactured in accordance with high safety standards.
Legal Compliance: By complying with EU directives, legal and financial risks are avoided.
CE Marking Process for Personal Protective Equipment
CE Marking requires the following stages.
- Risk Assessment:
The manufacturer evaluates the risks faced by the product and the measures taken against these risks.
- Technical File Preparation:
A technical file is prepared that includes documents such as product specifications, production process, test reports and risk assessments as given on the Regulation EU (2016/425) Annex III.
- Conformity Assessment:
Category I: The manufacturer declares that the product complies with the requirements, prepares the technical file and affix CE mark on the product.
Categories II and III: The product is tested and assessed by a Notified Body. For Category III products, continuous surveillance and inspection are also required.
- CE Marking:
The product is marked with the CE mark and an EU Declaration of Conformity is issued by Manufacturer. For Category III products, the CE marking is used with the Notified Body number.
- Market Surveillance:
The manufacturer guarantees that the product constantly complies with EU standards and repeats the tests and inspections when necessary.
SZUTEST is accredited by the Turkish Accreditation Agency (TÜRKAK) within the scope of the EU(2016/425) Personal Protective Equipment Regulation and authorized by the European Commission and carries out activities under Notified Body number 2195.
Modules we serve in the field of PPE according to product category;
- Module B; EU Type Examination – Annex V
- Module C2; Conformity to Type Based on Internal Production Control Plus Supervised Product Checks at Random Intervals – Annex VII
- Module D; Conformity to Type Based on Quality Assurance of the Production Process – Annex VIII
The product groups we provide services for as an accredited organization are briefly as follows:
- Foot and Leg Protective Equipment
- Head Protective Equipment
- Hand and Arm Protective Equipment
- General Body Protective Equipment
- Respiratory Protective Equipment
- Face and Eye Protective Equipment
- Hearing Protective Equipment
- Equipment designed to prevent drowning
- Equipment for protection against falls from a height
Specialized areas of competence that we service;
- Heat and Flame Protective Equipment
- Mechanical Risk Protective Equipment
- Equipment providing protection against extreme cold
- Protective Equipment against electric shock
- Protective Equipment against hand-held chain-saws
- Protective Equipment against harmful biological agents
- Protective Equipment against mechanical risks
- Protective Equipment against substances and mixtures which are hazardous to health
- Protective equipment against chemical agents
- Protective Equipment Against Risks Arising from Sports Activities
- Protective clothing against static electricity
- Protective Clothing for Use in Welding and Similar Processes
- Motorcyclist Equipment
- High Visibility Clothing
- Firemen Suits
For more detailed scope, you can also access our accreditation certificate via the following link.
https://api.turkak.org.tr/Utility/api/v1/PDF/EypPdf/5798d03a-32ce-4e95-abbe-b30ed1049eb7
CE marking for Personal Protective Equipment is a mandatory requirement for products to be legally sold on the European market. CE mark shows that the products are safe, effective and comply with high standards. As SZUTEST we provide full support to manufacturers in this process and makes it easy for your products to be CE marked.
At SZUTEST, As SZUTEST, we are experts in servicing manufacturers with the CE certification process for Personal Protective Equipment (PPE).
Our expertise ensures that your products comply with the strict safety, health and environmental protection requirements set by the European Union (EU). With our expert team, we expand your market access by ensuring that your products comply with EU standards.
SZUTEST serves you in the assessment of the conformity of your products, EU Type Examination Certification and other modules (Module C2 and Module D) both within its own competence and with many solution partners in different countries.
Contact us now for detailed information and application!
