In both the European Union and the European Economic Area, the marketing of Personal Protective Equipment (PPE) must comply with the technical criteria of Regulation EU 2016/425 (which amends Directive 89/686/EEC). This Regulation applies to manufacturers of Personal Protective Equipment and their authorised representatives, importers, etc., who are responsible for complying with its requirements.
The CE mark and the EU Declaration of Conformity ensure that PPE will be able to move freely within the European Market. Depending on the type of risk they protect against, sales of PPE may require an Authorised Body such as AENOR to issue a certificate of conformity for the type of risk at issue, based on assuring the quality of the production process (module D).
AENOR is notified of the conformity of Category II and III PPEs, in accordance with Module D: EU examination on Type and Assurance of the production process quality.
Category II and III Personal Protective Equipment are scrutinised by an Authorised Body.
AENOR is is notified of the conformity of Category II and III PPEs, in accordance with Module B and D: EU examination on Type and Assurance of the production process quality.
The list of standards that have been harmonised to comply with Regulation EU 2016/425 on Personal Protective Equipment includes more than 200 standards. Therefore, it's a good idea to check which standards apply to a specific product.
The CE Mark and EU Declaration of Conformity enable manufacturers of Personal Protective Equipment to access the European Market without restriction, which avoids technical barriers. What's more, the CE Mark is recognised in other markets globally.
The CE Mark ensures consumers that the product will not compromise their safety and guarantees certain common safety standards in Europe.
The requirements and conformity assessment modules are set out in Regulation EU 2016/425 on Personal Protective Equipment.
As regards certification, AENOR is accredited and authorised to assess conformity of the type model of the production process with the requirements of Regulation EU 2016/425 (module B) and the on the quality assurance of the production process (module D).
Audit visits are included in a straightforward way in conventional ISO 9001 audits. They are certified by AENOR or other bodies.
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AENOR assurance for fire protection, physical safety and individual and collective safety
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