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our PRODUCT
ADVISORS & MANAGEMENT masks are a Class I CE Medical Device and are manufactured in compliance with the requirements of the applicable standard, EN 14683: 2019. In particular, they comply with TYPE II of this standard.
In addition, they comply with the requirements of the applicable parts of ISO 10993, for biocompatibility.
The filter material with which the ADVISORS & MANAGEMENT masks are made (an SMS) is produced in Italy according to the quality standards necessary for medical applications and has been validated by numerous tests performed by both the manufacturer and users.
Compliance with the requirements of the standards was verified by carrying out the tests required by EN14683.
In particular:
• Bacterial filtration efficiency (BFE):> 98%
• Differential pressure (breathability): <30 cfu / g
The tests were performed in different laboratories and the bioburden test is repeated periodically to confirm that the production process maintains the necessary quality standards.
Breathability and bacterial filtration tests were performed on prototype masks, identical to those manufactured by ADVISORS & MANGEMENT.
These tests were performed by the manufacturer of the filter material, at the ABICH laboratory: The Verbania test.
The Bioburden test was performed on masks produced directly by the manufacturer according to the normal production cycle and was performed at the SAFE laboratory in Mirandola.
The cytotoxicity test was performed at the Tecnopolo laboratory in Mirandola (TPM).
The masks are produced in controlled contamination environments, with an automated process that minimizes the need for manual manipulation (which still takes place according to rigorous standards of hygiene and safety). Constant quality checks are performed to ensure compliance with specifications, including in particular for the welds of the profile of the mask and the bands. Each lot is released only after a verification process that ends with the issue of a Declaration of Conformity. The manufacturer operates in a quality system built according to the requirements of the ISO 13485 standard, currently in the certification phase. This includes procedures for the controls of raw materials, the recording of all activities carried out during the production phase, the traceability of each batch of finished product and raw materials, the quality management of storage and distribution. The labeling plan of the masks has been created according to the requirements of the directive 93/42 on medical devices and the ISO 15223 standard.
A complete technical file, which includes a clinical evaluation report and a risk analysis conducted according to the requirements of ISO 14971 is kept at the manufacturer's premises.
The Medical Device is CE marked by the manufacturer in accordance with Directive 93/42 and has been included in the database of medical devices of the Italian Ministry of Health (number 2000520).