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. |
LAL (Lysate of Limulus Amaebocytes) test
| Regulatory reference: | USP85. |
| Claim: | Absence of bacterial endotoxins |
| Application field: | Medical devices: raw ingredients and finished products. |
| Description of the test: | Lysate of limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins. |
H295R Steroidogenesis Assay – OECD 456
| Regulatory reference: | According to OECD 456. |
| Claim: | No endocrine disruption |
| Application field: | Raw ingredients and finished products. |
| Description of the test: | The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production. |
Mucoadhesion test
| Regulatory reference: | Proprietary method |
| Claim: | Mucoadhesive effect |
| Application field: | Finished products for direct application on external mucosae. |
| Description of the test: | Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control. |
Mucoadhesion test: gravimetric variant using the dry weight of the product
| Regulatory reference: | Proprietary method |
| Claim: | Mucoadhesive effect |
| Application field: | Finished products for direct application on external mucosae. |
| Description of the test: | Analysis of the resistance to washing off with and without a basal layer of mucin. Determination of the percentage of resistance against the same product on substrate without mucin. |
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. |
Quantification of the titer of substances
| Regulatory reference: | Regulation 1223/209 |
| Claim: | Titer of substances and Limit of preservatives |
| Application field: | Preservatives, dyes, sunscreen filters. |
| Description of the test: | Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps. |
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