ROSSINI 2025

4 38 STANDARDS AND CERTI FICATIONS Medical respiratory protective devices STANDARDS MDD 9 3 /4 2 EEC Directive 93/42 on medical devices (abbreviated as MDD 93/42) is a document setting out the general criteria to be used in designing and manufacturing certain categories of medical devices, currently in force in the European Union. It imposes EC marking requirements for marketing these medical devices; there are some essential requirements to be met for obtaining this marking. DDM CEE 93/42 classifies all devices into non-invasive or invasive: a device is considered invasive when it penetrates the body in part or fully, through an orifice or body surface; non-invasive devices, on the other hand, remain in contact with the skin, without penetrating the body. All non-invasive devices such as disposable surgical masks are rated Class 1. For surgical masks , the manufacturer must provide a self-certification, together with any useful element for the validation of the masks, to the Istituto Superiore di Sanità (National Institute of Health) which then proceeds to confirm whether the masks can be placed on the market or not. Disposable surgical, or medical, masks are certified according to European Standard EN 14683:2019+AC:2019 (UNI EN 14683:2019), which defines the design, manufacturing characteristics and test methods to ensure standardised effectiveness. The standard divides masks into three classes according to bacterial filtration efficiency (BFE): - Type 1 : BFE greater than or equal to 95%, differential pressure less than 40(Pa/cm²) and microbial cleanliness less than or equal to 30(cfu/g). This type of mask is used for patients to reduce the risk of spreading infections (especially in epidemic and pandemic situations). - Type 2 : BFE greater than or equal to 98%, differential pressure less than 40(Pa/cm²) and microbial cleanliness less than or equal to 30(cfu/g). They are designed for use by healthcare professionals in operating theatres or other medical practices. - Type 2R : BFE greater than or equal to 98%, differential pressure less than 60(Pa/cm²) and microbial cleanliness less than or equal to 30(cfu/g) and spray resistance pressure greater than or equal to 16kPa. These masks are suitable for people who want to protect themselves against splashes of contaminated biological material. Hearing protection devices STANDARDS The main standards for hearing protection PPE are as follows: EN 352-1:2020 earmuffs EN 352-2:2020 earplugs EN 352-3:2020 earmuffs for hard hats The average attenuation of a PPE is indicated by the decibel values H, M, L which represent the average attenuation of the device at HIGH, MEDIUM and LOW frequencies. The SNR indicates the average attenuation of the protector over the entire frequency spectrum. In implementing Directive 2003/10/EC relating to the exposure of workers to the risks arising from physical agents (noise) Legislative Decree 195/06 has become effective repealing Legislative Decree. 277/91 and Article 24 of Presidential Decree 303/56 (for hearing damage). Among the most significant changes is the lowering of the limit value (3dBA). The new intervention values are changed to: - Value below 80 dB(A) : the employer provides PPE - Value above 85 dB(A) : the use of PPE is mandatory. The employer and the RSPP, after consultation with the RLS, choose the appropriate PPE and check that it is being used. - Limit value 87 dB(A) : value which may not be exceeded in the working environment, taking into account the impulsive noise reduction