Personal Protective Equipment
Personel Protective Equipments are evaluated under 2016/425/EU Personel Protective Equipment Directive issued by the European Commission. 2016/425 /EU Personal Protective Equipment Directive has determined three categories as category I, II and III. Products are evaluated and certified according to these categories. At the end of the successful certification process, the manufacturer has the right to affix CE labels to its products.
There are two types of masks, which are with and without valves and which protect against dust particles are subject to conformity assessment and certification according to the EN 149 standard, a harmonized standard under this regulation. 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 manufacturers choose these classes.
The FFP classification described in the EN 149 standard is as following;
The European Commission has developed a procedure for half filter masks that will be newly documented due to the COVID 19 pandemic. This procedure is a new certification process for half masks with filters during this special emergency period we live in. Masks will only be evaluated to provide protection for the COVID 19 virus. The assessment saves time and money, by considering the EN 149 standard, ignoring all the details that are not required for virus protection. The table below compares the tests to which only masks providing protection for the COVID 19 virus and are subjected to the tests to which all protection types of the EN 149 standard are subjected to.
The World Health Organization has published an informative guide on the use of FFP2 and FFP3 class masks defined in this regulation and the standard, as required by the Covid-19 pandemic precautions. You can find the link of the relevant guide document in the resources section of this article.
Masks covered by the EN 149 standard are considered as Category III products described in the regulation. The certification process for the products in this category is as follows:
- Step :EC Type Examination Certification
Module B Certificate
For this, the manufacturer should create a technical file containing all the details of the products’ features. In addition, product samples must be tested in the accredited laboratory of the notified body. ‘EC Type Examination Certificate’ is published after the technical file is approved and the tests are completed successfully. The validity of the certificate is 5 years.
- Step : Module C2 or Module D Certificate
The EC Type Examination Certificate alone does not offer the right to affix CE labels to products. In addition to the Type Examination Certificate, manufacturers who want to affix a CE label to their products must have a certificate according to one of the following options. Manufacturers determine which complementary modules to implement.
- Option Module C2 Certificate (Conformity to based on internal control of production)
The Notified Body performs 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 conducts audits at the production facility at least once a year at random intervals. The validity of the module C2 certificate continues depending on the realization of surveillance audits.
- Option Modul D Certificate (Conformity to based on the quality assurance of the production)
Manufacturers who prefer to receive certificates according to this module must operate a quality management system. The notified body carries out the inspection of the quality management system applied at the production facility and publishes the certificate after the positive inspection.
In summary, mask manufacturers who want to affix CE labels to their products must have obtained Module B + Module C2 or Module B + Module D certificates. For more detailed information, you can review the regulation or contact Szutest Uygunluk Değerlendirme A.Ş. experts and get information.
2016/425/EU Personal Protective Equipment Regulation
EN 149+A1 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking
Link to the guide document published by the World Health Organization https://www.who.int/docs/default-source/documents/advice-on-the-use-of-masks-2019-ncov.pdf
PPE-R/02.075 Usage Suggestion Guide