Personal Protective Equipment is evaluated within the scope of the 89/686/EEC directive in the European Market and is a mandatory certification.
It is also a mandatory certification in Turkey. The Personal Protective Equipment Manufacturer company must test the product within the scope of the directive and fulfill the directive conditions and affix the CE mark to the product.
Personal protective equipment (PPE) health and safety requirements need to be defined and tested.
Products covered by the regulation
Foot protection equipment
Head protective equipment
Face and eye protective equipment
respiratory protective equipment
Hearing and ear protection equipment
Hand, arm and body protective equipment
Heat protection clothing
Personal Protective Equipment Certification Process
The relevant product is tested within the scope of the directive and in line with the attached norms.
A technical file of the product should be prepared together with the product. Along with the suitability of the product, the technical file is also examined.
Product Sample Review
A sample of the product is the confirmation phase that it has been produced as specified in the technical file.
The manufacturer can affix the ce mark in accordance with the ce regulation after the product conformity.
These masks, which are divided into two as with and without valve, and which provide protection against dust particles, are subject to conformity assessment and certification processes according to the EN 149 standard, which is a harmonized standard within the scope of this regulation. The protection type foreseen by this standard is dust particles. There is a classification as FFP1, FFP2 and FFP3 in the standard, and the tests in the conformity assessment process are designed and carried out according to which of these classes the manufacturers choose.
The European Commission has developed a procedure for filter half masks to be newly certified due to the COVID 19 pandemic. This procedure is a new certification process for filter half masks during this special emergency period we live in. Masks will only be considered to provide protection for the COVID 19 virus. The assessment provides significant time and financial savings by ignoring all the details that are not necessary for virus protection, taking into account the EN 149 standard. The table below compares the tests that only masks that provide protection for the COVID 19 virus are subjected to and the tests that masks that provide all protection types of the EN 149 standard are subjected to.
The World Health Organization has published an informative guide on the use of masks in the FFP2 and FFP3 classes defined in this regulation and standard, in accordance with the Covid-19 pandemic measures.
EC Type Examination Certification
Module B Certificate
Manufacturers should create a technical file containing all the details of their product’s features. In addition, product samples must be tested in the accredited laboratory of the notified body. Based on the approval of the technical file and the positive results of the tests, the ‘AT Type Examination Certificate’ is published. The validity of the certificate is 5 years.
Module C2 or Module D Certificate
The EC Type Examination Certificate alone does not provide the right to affix a CE label to products. Manufacturers who want to attach a CE label to their products must have a certificate according to one of the following options in addition to the Type Examination Certificate. The manufacturers themselves choose which of the complementary modules to implement.
Option Module C2 Certification (Conformity to type based on internal production control)
The Notified Body audits the production control stages carried out by the manufacturer regarding the mass production of the products and the inspection and tests carried out at the factory. In addition, in order to ensure the validity of the certificate, the notified body audits the production facility at least once a year at random intervals. The validity of the Module C2 certificate continues depending on the performance of surveillance audits.
Option Module D Certificate (Conformity to type based on quality assurance of production process)
Manufacturers who choose to receive certification according to this module must be operating a quality management system. The notified body performs the audit of the quality management system implemented in the production facility and issues the certificate after the positive audit.
In summary, mask manufacturers who want to affix the CE label to their products must have obtained Module B + Module C2 or Module B + Module D certificates.