CERTIFICATIONS
The masks are produced in accordance with the requirements of UNI EN 14683:2019+AC:2019 (facial masks for medical use – Requirements and test methods).
In addition to having all the characteristics required for materials, production, and design, masks have passed several tests to ensure conformity for the CE marking.
In addition to the mask certification as a product, the certification of the manufacturing process through the quality management system ISO 13485 also plays a very important role in ensuring compliance with the regulations for the medical device sector.
All the production phases are controlled by the Manufacturer in accordance with Directive 93/42/CEE in compliance with the provisions of the Ministry of Health for the production and marketing of medical devices.
99,7% BFE (type IIR)
Bacterial Filtration Efficiency or BFE is a measurement of a respirator material’s resistance to penetration of bacteria. Results are reported as percent efficiency and correlate with the ability of the fabric to resist bacterial penetration.
Higher numbers in this test indicate better barrier efficiency.
Compliance with differential pressure test
This test measures the resistance of the facial mask to the air flow. A controlled air flow is passed through the mask and the pressure is measured before and after. The pressure difference is divided on the sample surface (in cm2). A lower breathing resistance indicates a higher comfort for the user.
Certified Beta ray treatment
Masks are subjected to a special Beta ray treatment that allows to break down the bacterial charge that may be present. New generation equipment ensures the control of packaging contamination and allows to provide hygienic and sanitized products, without danger of chemical residues on processed products. Masks are hygienic and safe.
Compliance with Bioburden test
Bioburden is defined as the number of micro-organism living on a product before the sanitizing process. They can be viral, bacterial, and fungal. They can have three main sources: the production environment, the production personnel, and raw materials. Masks are subjected to specific treatments and periodic checks to make sure that the microbial cleaning requirements of the reference standard are met.
Fibreglass and latex free
The choice of the mask materials plays a major role in the design. The biocompatibility test, carried out according to EN ISO 10993-1:2010, ensures that masks are also safe from an allergenic point of view as they do not irritate the point of contact with the skin.
Splash test
Type IIR masks have passed the splash resistance test, therefore, they are also suitable for professional medical use, where it is necessary to ensure the protection of operators from liquid splashes.
3 ply
RIVALAB masks are composed of a filtering MELT-BLOWN non-woven fabric ply and two Spunbound non-woven fabric ply. A combination that meets the main requirement of this product: creating a protection, resulting at the same time highly permeable to air.
Elastic bands
Practical and comfortable, elastic ear-loop bands guarantee absolute fit for masks always ready to be worn with a simple gesture.
Nose clip
The special nasal band conformable according to the characteristics of the user’s face ensures maximum product adaptability and complete comfort during use.
2 resealable bags
The masks are contained in practical transparent plastic bags with pressure closing. Every package includes 2 bags of 25 masks. Being resistant and resealable, the bags can be used daily to store the mask or to bring a stock of clean masks always with you.
Cardboard box
The boxes contain 36 packs of 50 masks, a total of 1800 pieces. Each cardboard box shall have a label indicating the type of product, the quantity and the lot number.
Made in Italy
RIVALAB masks are manufactured and packaged in Italy: a guarantee of the highest quality for your safety and your protection.
Medical device registration numbers available on the website of the Ministry of Health:
MASKLAB: 1990503
MASKLAB II: 1990505
LIFELAB: 1990507
KITLAB: 1990514
MEDILAB: 2008466