Determination of breathability (differential pressure) on surgical masks
| Regulatory reference: | UNI EN 14683:2019. |
| Claim: | Determination of breathability |
| Application field: | Raw materials and finished products. |
| Description of the test: | Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity. |
In vitro skin irritation test according to ISO 10993-23:2021
| Regulatory reference: | ISO 10993-23:2021. |
| Claim: | Biocompatible |
| Application field: | Raw materials and finished products. |
| Description of the test: | In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021. |
Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019
| Regulatory reference: | UNI EN ISO 11737-1:2018 and UNI EN 14683:2019. |
| Claim: | Determination of bacterial charge |
| Application field: | Raw materials and finished products. |
| Description of the test: | The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage. |
Bacterial Filtration Efficacy (BFE) testing according to ISO 14683
| Regulatory reference: | ISO 14683:2019 (B). |
| Claim: | BFE (Bacterial Filtration Efficiency) |
| Application field: | Raw materials and finished products. |
| Description of the test: | Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks. |
Determination of antiviral activity of textile products according to ISO 18184:2019 (E)
| Regulatory reference: | ISO 18184:2019 (E). |
| Claim: | Antiviral activity |
| Application field: | Raw materials and finished products. |
| Description of the test: | The test can be performed on textiles (wool, fibers, spun materials, bundles, knitwear fabrics). Tested products can be used in hospitals and healthcare facilities, or as upholstery materials on transports. The virus strands used in the test are “Type A flu” and “Feline carcinovirus”. Other virus strands can be tested upon requests, following a feasibility study. |
Antiviral activity on plastics and other non-porous surfaces according to ISO 21702:2019 (E)
| Regulatory reference: | ISO 21702:2019 (E). |
| Claim: | Antiviral activity |
| Application field: | Raw materials and finished products. |
| Description of the test: | The test can be performed on plastics, upholstery materials, ceramics, natural or artificial leather, stainless steel, rubbers. The virus strands used in the test are “Type A flu” and “Feline carcinovirus”. Other virus strands can be tested upon requests, following a feasibility study. |
Quantification of trace substances and impurities
| Regulatory reference: | UE Regulation |
| Claim: | Titer of substances |
| Application field: | Cosmetics and medical devices. |
| Description of the test: | Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation. |
UV protection of textile products (UPF)
| Regulatory reference: | BS EN 13758-1:2001 |
| Claim: | UV protection factor for textiles (UPF) |
| Application field: | Textile fabrics, clothes, bandages. |
| Description of the test: | Evaluation of the protection in the UV spectrum granted by textile protective items or similar products through analysis of the absorbance. |
Stability test
| Regulatory reference: | ICH or ISO |
| Claim: | Accelerated stability tests |
| Application field: | Medical devices and cosmetics. |
| Description of the test: | Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics. |
Posted in Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Accelerated stability test, Substance-based, Surgical devices and medications, Make up, Claim for cosmetics, Claim for medical devices, Accelerated stability tests
Biocompatibility test
| Regulatory reference: | ISO 10993-10 |
| Claim: | Biocompatible |
| Application field: | Finished products, textiles, solid products by eluate. |
| Description of the test: | Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential. |
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