Personal Protective Equipment (PPE)
We at TCMS in alliance with Gepteszt 2233 Hungary have full scope to certify the products falling under PPE Regulation (EU) 2016/425. Personal Protective Equipment (PPE) is defined as any device intended to be worn or held for protection from injury. In Europe, placing PPE products on the market is regulated by Regulation (EU) 2016/425.
PPE Regulation (EU) 2016/425 has replaced the PPE Directive 89/686/EEC in April 2018, covers the manufacturing of PPE to ensure the highest level of protection. The CE mark on PPE is an evidence that the PPE Complies with relevant standards and are safe for use.
Our expertise in assessing Personal Protective Equipments manufacturers around world to test and certify their products. Our experienced Certification team can assist manufacturers in choosing the correct procedures and test methods for their products, and provide guidance on aspects of the type-examination such as Technical File content, Labelling, and User Information.
CE Certification of Face Mask/Respirator:
Face masks typically fall into one of two categories — surgical (MDD) or respirator (PPE). Both variants are designed to offer various levels of protection against the transmission of bacteria.
“Respirator masks” Fall under PPE Regulation. Respirator masks are divided into three categories: FFP1, FFP2 and FFP3. Protective masks are PPE of category III according to the Regulation (EU) 2016/425. This means that the conformity assessment includes a type examination by a notified body, resulting in a ‘EU type examination certificate’ as well as production follow-up by a notified body (random checks or system audit). This results in CE marking with the number of the notified body responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany the PPE, together with the instructions for use.
Applicable Standard on Face Mask:
EN 149:2001 + A1:2009: Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking.
The major tests in EN 149: 2001 + A1:2009 are:
- Total inward Leakage
- Penetration of filter material
- ompatibility with skin
- Flammability
- Carbon dioxide content of inhalation air
- Head Harness
- Field of vision
- Exhalation Valves
- Breathing Resistance
- Clogging
We at TCMS in alliance with Notified body Gepteszt (No. 2233) can certify the Face Mask/Respirators under PPE Regulation (EU) 2016/425
CE Certification of Fall Protection Equipment:
Equipment designed to protect user against fall from height fall under PPE regulation (EU) 2016/425. Fall protection equipment fall under category III according to the Regulation (EU) 2016/425. This means that the conformity assessment includes a type examination by a notified body, resulting in a ‘EU type examination certificate’ as well as production follow-up by a notified body (random checks or system audit). This results in CE marking with the number of the notified body responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany the PPE, together with the instructions for use.
PPE Category wise Requirement:
| Category | Requirement | Applicable Modules |
|---|---|---|
| Category I | Internal Production Control a process that requires the development of a technical file which includes the manufacturer’s Declaration of Conformity. | Internal production control (module A) |
| Category II | EU-type examination by a Notified Body. | EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) |
| Category III | EU Type Examination certificate and ongoing assessment of compliance. Audit the manufacturing site annually to ensure that quality management systems are in place. | EU type-examination (module B) set out in Annex V, and either of the following:
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