CE Article 10 & Article 11B

It Is Important to Check both CE Certificate and Article 11B (or 11A) When Purchasing CE-marked PPE

Personal Protective Equipment (PPE) is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards’’. The PPE Directive 89/686/EEC is the basis upon which manufacturers are authorized to affix the CE mark.  

 

As the scope of the PPE Directive includes a wide range of products, it divides them into three categories. Chemical protective clothing must be CE certified as Category III PPE. Such clothing meets the minimum performance requirements of the specific product standard, is identified with a “CE mark” followed by the 4 digit code of the notified body.

 

In addition to initial CE certificate, the manufacturer must ensure the product meet the certification performance claims. According to article 11 of the PPE directive, it must be subject to an annual audit by notified body, who certifies PPE continues to comply with the CE certification claims.

 

 •    Article 11A: Final Product Monitoring –               

 A random sample inspection of recently manufactured items which are tested by methods used in the original EC type-examination to ensure continuing compliance.

 

•    Article 11B: Quality System Monitoring –

Checks are made at manufacturing site that the quality systems are capable of enabling consistent production of the certified product. 

 

However, it is worth remembering that, with the exception of complex category products which require Article 11 monitoring, there is no requirement for a Notified Body to see examples of PPE produced after initial type-examination. It is, therefore, always important to be cautious when purchasing CE-marked PPE – not only asking to see a copy of the original EC type-examination certificate issued by the Notified Body, but to also request ongoing evidence demonstrating that current production continues to be compliant.