Production PPEs- FFP2 FFP3
In the guides that the Spanish Ministry of Industry, Trade and Tourism publishes on its website, one can find those that refer to the regular manufacturing process for PPE masks and how to legalize them.
What are the Personal protective equipment PPE
We understand PPE as a product intended to be worn by a person in order to protect against any health risk.
PPE masks are intended to filter the inhaled air, preventing the entry of polluting particles into the body.
PPE protective equipment personnel must be CE marked in accordance with regulations of the European Union on 2016/425 personal protective equipment, which explains what PPE is as well as the conditions to be fulfilled and the processes to be followed by manufacturers to market it.
Can masks be considered PPE?
Masks intended to protect those who wear them against the inhalation of hazardous substances are PPE and are therefore required to comply with EU-2016/425 regulation.
As is known, there are other types of masks which are not PPE such as surgical masks which are medical devices and which must comply with Directive 423/92 / EEC.
Existing types of PPE masks
In annex II on the essential health and safety requirements that PPE must meet, and which is included in regulation EU-2016/425, there is a standard EN 149: 2001 + A1: 2009 in which are defined the different types of protective masks against particles that can:
Depending on their performance and their maximum total internal leakage, there are three classes of devices:
FFP1, FFP2 and FFP3
For protection against COVID-19, the use of PPE FFP2 masks is recommended.
Whatever the material used for their manufacture and according to the results obtained in the tests carried out, they are classified into 3 groups:
masks Low efficiency FFP1: filtering at least 80% of aerosols (total inward leakage <22%)
Medium performance FFP2 masks: filtering at least 94% of aerosols (total inward leakage <8%)
High efficiency FFP3 masks: filtering at least 99% of aerosols (total inward leakage <2%).