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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

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Abich obtained ACCREDIA certification

 
The ACCREDIA Certification, issued by the Italian Accreditation body ACCREDIA, certifies that the Abich Laboratory complies with the requirements of the UNI CEI EN ISO / IEC 17025: 2018 standard for tests on surgical masks. Accredited tests are Bacterial Filtration Efficiency (BFE) and Microbial Cleanliness (Bioburden).
 
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