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

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.
Posted in Mucoadhesive products, Raw materials for medical devices, Surgical devices and medications, Mucoadhesive effect, Claim for medical devices

Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of caffeine

Regulatory reference: Proprietary method
Claim: Barrier effect
Application field: Solutions or finished products.
Description of the test: Quantification by HPLC of the amount of caffeine permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.
Posted in Barrier effect, Protection and barrier effect, Claim for medical devices

Resistance to washing off by saliva

Regulatory reference: Proprietary method
Claim: Resistance to washing off by saliva
Application field: Finished products for oral application.
Description of the test: Analysis of the resistance to washing off by artificial saliva by gravimetric analysis of the dry weight of the sample before and after washes in controlled conditions.
Posted in Mucoadhesive products, Resistance to washing off by saliva, Claim for medical devices

Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of testosterone

Regulatory reference: Proprietary method
Claim: Barrier effect
Application field: Solutions or finished products.
Description of the test: Quantification by HPLC of the amount of testosterone permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.
Posted in Barrier effect, Protection and barrier effect, Claim for medical devices

Skin tolerability test under dermatological supervision

Regulatory reference: Guidelines to Commission Regulation (EU) No 655/2013
Claim: Dermatologically tested
Application field: Heating and cooling medical devices and cosmetic products.
Description of the test:
  • Measurement at T=0 before the application and after a preset duration agreed upon with the sponsor;
  • Temperature control using an infrared non-invasive thermometer;
  • Evaluation of the erythemal response through skin colorimetry using a Mexameter® MX18 colorimeter (Courage-Khazaka GmbH – Germany);
  • Evaluation by clinical experts of the general conditions of the skin and epidermal tolerability during use;
  • Subjective evaluation through predefined questionnaire with numerical score system (visual analogical scale) and judgement of the tolerability and heat/chill feeling as perceived during the application of the product;
  • Comparative photography with colorimetric reference captured with a 100 mm macro objective and normalization of the color with coaxial circular flash.
Posted in Heating and cooling products, Dermatologically tested, Claim for medical devices