Clinical tests with high resolution infrared camera using healthy volunteers
| Regulatory reference: | Proprietary method |
| Claim: | Infrared thermography |
| Application field: | Raw materials and finished products. |
| Description of the test: | Simulation in conditions of long or short term use of the medical device. The test includes mathematical processing of physical data in order to have a quantitative result of the change in the temperature of the skin treated by the product over time. |
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: |
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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. |
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 Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Accelerated stability test, Substance-based, Surgical devices and medications, Make up, Claim for cosmetics, Claim for medical devices, Accelerated stability tests
Biocompatibility test
| Regulatory reference: | ISO 10993-10 |
| Claim: | Biocompatible |
| Application field: | Finished products, textiles, solid products by eluate. |
| Description of the test: | Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential. |
Challenge Test
| Regulatory reference: | ISO 11930 for cosmetics; European Pharmacopoeia for medical devices |
| Claim: | Efficacy of preservatives |
| Application field: | Cosmetics and medical devices. |
| Description of the test: | Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices). |
Posted in Vaginal products and Condom, Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Make up, Moisturizers, Preservative systems, Claim for cosmetics, Claim for medical devices, Efficacy of preservatives
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