Claim for medical devices

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.
Posted in Fabrics, plastics and polymer patches, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Claim for medical devices, Biocompatible

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.
Posted in Determination of bacterial charge, Fabrics, plastics and polymer patches, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Claim for medical devices

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.
Abich successfully took part in the first Interlaboratory BFE Round-Robin organized by a certified ISO/IEC 17043 provider to guarantee the accuracy of analytical data for surgical masks testing.
Posted in BFE (Bacterial Filtration Efficiency), Fabrics, plastics and polymer patches, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Claim for medical devices

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.
Posted in Antiviral activity, Fabrics, plastics and polymer patches, Claim for medical devices

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.
Posted in Antiviral activity, Fabrics, plastics and polymer patches, Claim for medical devices

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.
Posted in Raw materials for medical devices, Absence of bacterial endotoxins, Claim for medical devices

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.
Posted in Cosmetic raw materials, Raw materials for medical devices, No endocrine disruption, Claim for cosmetics, Claim for medical devices

Evaluation of barrier effects on 3D reconstructed human epidermis

Regulatory reference: Proprietary method
Claim: Protects and repairs the cutaneous barrier
Application field: Topical products.
Description of the test: Evaluation on 3D in vitro epidermis of the efficacy of a product in protecting against acids, alkalis or solvents.
Posted in Protection and barrier effect, Protects and repairs the cutaneous barrier, Claim for medical devices

Evaluation of barrier effects on 3D reconstructed human epidermis and analysis of inflammatory cytokines

Regulatory reference: Proprietary method
Claim: Protects and repairs the cutaneous barrier
Application field: Topical products.
Description of the test: Evaluation of the protective efficacy against acids, alkalis or solvents on in vitro 3D human epidermis, paired with evaluation of the protection against pro-inflammatory substances.
Posted in Protection and barrier effect, Protects and repairs the cutaneous barrier, Claim for medical devices

Wound healing test

Regulatory reference: Proprietary method
Claim: Improves cicatrization
Application field: Wound healing products.
Description of the test: Analysis of the regenerative efficacy on epidermal cell cultures after simulated wounding. Results in terms of percentage of improvement in the regeneration kinetics versus untreated substrate.
Posted in Improves cicatrization, Surgical devices and medications, Claim for medical devices