Claim for medical devices

Pre-injection swab test

Method for Evaluation of Preinjection Skin Preparations

 

Regulatory reference: According to ASTM ASTM E1173 – 15.
Claim: Effectiveness of alcohol swabs
Application field: Finished products.
Description of the test: The test method is designed to measure the reduction of the microflora of the skin for Preinjection Skin Preparations. This test method is conducted on human subjects selected randomly from a group of subjects who, after refraining voluntarily from using topical and oral antimicrobials for at least two weeks (14 days), exhibit acceptably high normal flora counts on the skin sites to be used in testing.
Posted in Effectiveness of alcohol swabs, Claim for OTC, Claim for medical devices

Time-Kill Test

Assessment of Antimicrobial Activity Using a Time-Kill Procedure

 

Regulatory reference: According to ASTM E2315 – 16.
Claim: Kills 99.99% of germs
Application field: Finished products.
Description of the test: Antimicrobial activity of specific materials is measured with this technique by measuring the changes in a population of aerobic microorganisms within a specified sampling time. This test can be used in particular for the hand sanitizers with the claim “kills 99.99% of germs”.
Posted in Kills 99.99% of germs, Claim for OTC, Claim for medical devices

H295R Steroidogenesis Assay – OECD 456

Regulatory reference: According to OECD 456.
Claim: No endocrin 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 endocrin 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 healing process
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 healing process, 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

Saliva resistant

Regulatory reference: Proprietary method
Claim: Saliva resistant
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 Saliva resistant, Mucoadhesive products, 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