Claim for medical devices

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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

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

Protection and barrier effect test on oral epithelium with analysis of IL1-Alpha expression

Regulatory reference: Proprietary method
Claim: Protects and repairs the cutaneous barrier
Application field: Topycal products.
Description of the test: Measurement of inhibitory efficacy of an active ingredient or finished product against the adhesion of Staphylococcus aureus to epithelial cells.
Posted in Protection and barrier effect, Protects and repairs the cutaneous barrier, Claim for medical devices

Barrier effect test against microbial strains

Regulatory reference: Proprietary method
Claim: Inhibition of bacterial adhesion
Application field: Raw ingredients or finished products.
Description of the test: Measurement of inhibitory efficacy of an active ingredient or finished product against the adhesion of Staphylococcus aureus to epithelial cells.
Posted in Protection and barrier effect, Inhibition of bacterial adhesion, Claim for medical devices

Percutaneous absorption test

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

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.
Posted in Fabrics, plastics and polymer patches, Cosmetic raw materials, Raw materials for medical devices, Surgical devices and medications, Claim for cosmetics, Claim for medical devices, Titer of substances

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.
Posted in Heating and cooling products, Mucoadhesive products, Cosmetic raw materials, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Claim for cosmetics, Claim for medical devices, Titer of substances, Limit of preservatives

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.
Posted in Fabrics, plastics and polymer patches, UV protection factor for textiles (UPF), Claim for medical devices

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 Fabrics, plastics and polymer patches, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Substance-based, Surgical devices and medications, Make up, Claim for cosmetics, Claim for medical devices, Accelerated stability tests

Compatibility test for use with condoms

Regulatory reference: Proprietary method based on ISO 4074
Claim: Compatible with latex condoms
Application field: Vaginal products and lubrificants.
Description of the test: The test evaluates the compatibility of the product with latex or polyurethane condoms through analysis of the changes of the resistance of condom samples after treatment with the product.
Posted in Condom and vaginal products, Compatible with latex condoms, Claim for medical devices

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