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New guidelines for training, selection and use of Respiratory protective devices in Italy

Let's take a look at the legislative update in the field of Safety at Work introduced by Legislative Decree no. 146 of October 21st 2021, (coordinated with Conversion Law no. 215 of December 17th 2021), containing Urgent measures on economic and fiscal matters, to protect labour and for urgent needs.


PPE belongs to a complex and highly regulated world.

Since the beginning of this year, a legislative update has come into force that should be dwelled upon, especially for the impact it has had on the choice and use of Personal Protective Equipment (PPE) for the respiratory tract.


In particular, with the new UNI11719:2018 standard, a systematic approach to respiratory protection has been introduced with a 'Respiratory Conservation Programme'.


The most impactful changes are represented specifically by the amendments made to DL April 9th 2008, no. 81 (Art. 79: Criteria for the identification and use, 2-bis), which are part of the process of adopting a respiratory tract PPE, which see all the following steps regulated.







The passage that concerns the Choice and Use (1) of PPE looks at the standards that regulate its choice, which must be weighted on the basis of the airborne concentrations of the pollutant and what the standard defines as operational protection factors. The latter take into account several factors: Protection Factor (PF), Required Protection Factor (RPF), Nominal Protection Factor (NPF), Operational Protection Factor (OPF), Leakage Factor (LF).


But the main differences lie in the two central operations of the process: training and fit test.



How has training for the use of respiratory PPE changed?

With this DL, the handling of these activities is spelled out in great detail.


"Training consists of the practical test, for the correct and safe use of equipment, machines, plants, substances, devices, including personal protective equipment; training also consists of applied exercise, for safe working procedures. The training operations performed must be recorded in a dedicated register, also in computerised form."


The highlighted passages highlight all the novelties introduced, which in essence outline a new approach to checking the assimilation by each trained subject of all safety procedures. In fact, it becomes mandatory to repeat the training periodically, at least once a year. In addition, the training will have to be held by a competent person, defined as one who has received special training for this purpose and who, at appropriate intervals, follows a refresher course.


What has changed in the fit test for the use of respiratory PPE?

The 'fit test' is the test to verify the suitability of the device; the fit of the device to the wearer is an operation that from now on will be included in the so-called Respiratory Protection Programme.




The importance of sealing

  • The device must be positioned correctly on the face and head;
  • The nose clip must be moulded to the nose and cheeks to ensure a good fit;
  • Select the correct mask size according to the size of the face;
  • Place the upper elastic band on top of the head. Do not twist the elastic band;
  • The lower elastic should be placed under the ears on the neck. Do not twist the elastic band;
  • The folding devices ensure that the limbs are completely open.


Why was the Fit Test introduced into the standard?

INAIL (Istituto Nazionale per l'Assicurazione di Infortuni sul Lavoro - National Institute for Occupational Accidents Insurance) pushed for the introduction of new criteria for the choice of PPE and the introduction of the Fit Test as a test to verify the goodness of the choice made, to a compulsory extent.


Please note: The fit test is NOT a leak test!


Whenever PPE is used, a fit test must be performed before use (commonly referred to as a 'fit test'), i.e. an individual assessment of the fit before use by the user. Before the fit test can be performed correctly, the user must perform a fit test on the device being worn.



Appendix A of the standard: Fit Test

The fit test must be performed on facepieces depending on the specific wearer. In fact, a facepiece will only provide the estimated protection if the seal on the face is ensured. It is possible that one size or model may not fit all wearers. Assessing the correct fit is a fundamental part of the selection process. The fit test is used to verify that the tight-fitting facepiece fits the subject's face. The most commonly used methods are the qualitative test and the quantitative test, commonly referred to as qualitative fit test (A.2) and quantitative fit test (A.3).

Briefly, during the qualitative fit test, the test subject must state whether or not he or she perceives the substance. The assessment is subjective. In contrast, the quantitative fit test returns an objective data on what is happening inside the worn device by means of a special measuring device. In addition, the quantitative fit test makes it possible to record the passing or failing of the test, because all fit test results are entered into an automated register designed to keep track of the tests performed.


From this year, by law, the reporting of the Fit Test must appear in a special register.


In other countries, such as Great Britain and Belgium, the Fit Test has been compulsory for many years. However, in none of these countries is the type of competence of the person carrying out the Fit Test defined. In the absence of an official qualification of the operator, in fact, a voluntary qualification scheme based on 14 competences was introduced to guarantee the suitability of the tests performed.

The same model has also been adopted in Italy.

In Italy, Assosistema will manage this qualification scheme, in a totally transparent manner. This qualification scheme is called 'Fit2Fit' and has been adopted in recent years by an increasing number of European states, in a general progress of expansion of competence assessment schemes.

To summarise, registering has now become mandatory and this will mean more safety for users and more obligations for manufacturers and distributors of Personal Protective Equipment.


So what do you recommend to check that you are in line with the new regulations?



  • Prepare the respiratory protection programme and appoint the Programme Manager;
  • Update the assessment taking into account the new selection requirements, which refer not only to the new protection values (FPO), but also consider other aspects. This assessment should be adequately spelled out in the PPE assessment documents;
  • Maintenance: for respiratory protective devices follow the UNI11719:2018 indications for management.


  • Respiratory protective devices : prepare and record the suitability test (Fit-Test) for leak-proof APVR (Appendix A of UNI11719:2018).


  • verify that the contents are consistent with the new amendments to Art.13 paragraph 5 of DLgs.81/08;
  • Record the training in a special register.


Stay informed
Stay safe.


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