PPE is considered to be any item designed to be worn or held by an individual for protection against one or more safety hazards. In Europe, placing PPE products on the market is regulated by the PPE Regulation (2016/425). This applies to most safety products intended for use in leisure and sports activities, as well as for professional use.
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All PPE products covered by 2016/425 must meet the Essential Health and Safety Requirements (EHSR) listed and described in the PPE Regulation.
PPE Testing
Our testing laboratories provide comprehensive testing services on many types of PPE:
Medical equipment
- Face masks
- Eye protection
- Protective clothing: gloves and gowns
Equipment and accessories
- Eye protection: sunglasses, swimming goggles
- Head protection: safety and sports helmets
- Arm/leg protection: wrist, palm, knee and elbow protectors
Clothing and footwear
- Protective clothing: high visibility clothing, motorcyclists’ protective clothing, welding clothing, and heat & flame protective clothing
- Protective footwear: safety, protective, occupational footwear
- Protective gloves: protection against mechanical risk, welding, thermal risks
The first step to check the quality of PPE is to conduct testing to assess the compliance with relevant test standards. Harmonized standards have been published for the PPE directive and compliance provides a presumption of conformity with the EHSR of the Directive.
In addition to the testing, the harmonized standards also describe the requirements for User Information and Product Marking.
PPE Certification
Regulation (EU) 2016/425 classifies all PPE into one of three risk categories – I, II and III – each requiring the manufacturer to produce an EU Declaration of Conformity (DoC).
| PPE Category | Certification requirements |
|---|---|
| Category I: Simple products, such as gardening gloves, sunglasses, etc. | Manufacturer can self-certify, a process that requires the development of a Technical File which includes the manufacturer’s Declaration of Conformity. |
| Category II: Safety and sports helmets, safety footwear, high visibility clothing, etc. | Manufacturers require an EU Type Examination (Article 10) by a Notified Body, such as SGS. This can be done by developing a Technical File including independent testing reports/results. |
| Category III: Complex products, such as respiratory equipment, fall arrest equipment and chemical protective clothing. | Require an EU Type Examination (Article 10) and ongoing assessment of compliance (Article 11). Under Article 11, the client can choose to have the Notified Body:
|
CE Marking
We provide EU Type Examination certification for Category II and III products through SGS Fimko – Notified Body (0598).
We also provide annual factory audits for Category III products through our global auditor network. After certification, qualifying products must display the CE Mark.
Why choose PPE testing and certification from SGS?
Our global network and experts provide you one stop simple solutions for PPE product compliance with testing and certification requirements. Our accredited laboratories also provide assistance in compiling technical files and coordinate with Notified Bodies for application of EC type examination.
Contact us today for more details.