Masks

Surgical masks are medical devices not to be confused with Personal Protective Equipment (eg FFP2, FFP3).
In the context of the current Covid-19 emergency, the Istituto Superiore di Sanità (ISS) is the reference body for self-certification of surgical masks. In the document Procedures For Requesting The Production Of Masks, ISS summarizes the necessary tests for the certification of the surgical masks, in particular:

Certificate of Analysis of mask according to the UNI EN 14683: 2019 “Facial masks for medical use – Requirements and test methods”:
• Bacterial Filtration Efficiency (BFE) (in%)
• Breathability (in Pa / cm2)
• Microbial cleaning (Bioburden)
• Splash resistance (only for type IIR)
The test reports must be uploaded in Italian or English.

Certificate of Analysis of mask of biocompatibility tests on the finished product according to UNI EN ISO 10993-1: 2010 “Biological evaluation of medical devices-Part 1: Evaluation and tests within a risk management process”:
• Cytotoxicity,
• Skin irritation
• Allergic sensitization
As an alternative to the test report, the proposer can produce a biological assessment report written on a bibliographical basis.
The test reports must be uploaded in Italian or English

In addition to the tests, the self-certification requires a minimum level of procedures for a quality system and some labeling requirements.

Gelt International offers support for all the above requirements.