Introduction to the issue of personal protective equipment legislation focusing on respirators and face masks
If respirators and face masks are intended for personal protection, they can fall into two basic categories of legislation: personal protective equipment (“PPE”) and medical devices (“MD”).
The difference between the two categories is in the intended purpose of use.
Personal protective equipment is intended for the protection of a user from external health risks (it is typically protective glasses, life vests, helmets, respirators).
Medical devices are intended for the protection (and illness prevention) of a person other than a medical device user (an example of a medical device could be a face mask because it is intended for the protection of a patient’s health from a possible infection, not for the protection of operating staff during an operation).
A product can fall not only into one, but also both PPE and MD categories, in which case it must meet the statutory requirements applicable to both categories.
Certifications at the Occupational Safety Research Institute (OSRI)
In the Personal protective equipment category Respilon offers two types of respirators (filtration half masks) – RespiPro Carbon and RespiPro.
RespiPro Carbon is certified in compliance with the Czech technical standard (CSN) EN 149+A1 for the FFP2 protection class.
RespiPro is certified for the FFP 1 class.
Both types of respirators are certified by the Occupational Safety Research Institute (notified body 1024 under the Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC) and meet all statutory requirements for placing them on the market.
The State Institute for Drug Control notifications for Medical devices (MD)
A face mask is a product that serves as protection for people other than the face mask users. For that reason they are classified as medical devices and fall into risk class I (or risk class I sterile).
From the Medical devices (MD) category, the company Respilon can offer the ReSpimask products. Because it is a Medical device of class I non-sterile, no certification is needed in order to place the product on the market. It is obligatory to have a so-called notification from the State Institute for Drug Control which is a subsequent administrative duty, not a condition for the placing of a product on the market.
Before placing a face mask on the market it is necessary to assess its conformity This process is carried especially in compliance with Government Regulation No. 54/2015 Coll., on the technical requirements for medical devices and the Czech technical standard (CSN) EN 14683+AC Medical face masks – Requirements and test methods
According to this standard, face masks can be classified as Type I, Type IR, Type II or Type IIR. Higher classification means higher product efficiency and the letter R means that a product has a certain protective property (particularly a so-called “splash resistance” – protection from getting stained with a patient’s blood e.g., during an operation).
The assessment of conformity is done by the manufacturer him/herself, in case of the sterile face masks this process of ensuring the sterility is overseen and evaluated by a notified body which issues underlying documentation for the CE conformity marking.
A manufacturer placed in the Czech republic has the obligation, after placing a face mask on the market, to submit the co-called notification at the State Institute for Drug Control in compliance with Act No. 268/2014 Coll., on medical devices and on amendments to Act No. 634/2004 Coll., on administrative fees, as amended.
The notification is only an administrative measure which is not a condition for the placing of a face mask on the market and does not affect the legality of its sale.
Respilon has in its portfolio one product of this category. It is the medical device ReSpimask, risk class I, Type IIR of the Czech technical standard (CSN) EN 14683. Our ReSpimask products were launched already in 2013. The administrative duty of the notification under medical devices legislation has been in effect since 1st April 2015. Because of design modifications in ReSpimask a new notification that takes these modifications into consideration has been submitted.
ReSpimask products meets all statutory requirements to be freely sold in the Czech republic.
Moreover, for ReSpimasks, Respilon has confirmation and protocols of the following testing:
- a testing from Nelson Labs for the interception of viruses, bacteria and particles which confirms the 99.9 % filtration efficiency;
- a protocol of the Occupational Safety Research Institute on the filtration of solid particles and the penetration of paraffin oil;
- a test report about the filtration efficiency from the Engineering Test Institute;
- a skin irritation test from the National Institute of Public Health;
- a test of the tight fit of a mask from the Brno University of Technology;
- a test report on the filtration efficiency from a Swiss company EMPA (the Federal Laboratories for Materials Science and Technology);
- and an analysis of life cycle risks from the Czech institute of risk management (Institut Managementu Rizik).