Mise à jour des normes harmonisées pour les règlement (UE) 2017/745 (dispositifs médicaux) et (UE) 2017/746 (dispositifs de diagnostic in-vitro).

Dispositifs médicaux : Commission implementing decision (EU) 2026/2479 of 9 November 2026 :

• Deux normes sont mises à jour :
  • EN ISO 14155 (clinical investigation of medical devices for human subjects – Good clinical practice) et
  • EN ISO 11137-1 (Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical device)
• Les normes suivantes sont ajoutées :
  • EN ISO 4074:2026 – Natural rubber latex male condoms – Requirements and test methods
  • EN ISO 10993-6:2026 – Biological evaluation of medical devices – Part 6: Tests for local effects after implantation
  • EN ISO 10993-7:2026 – Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
  • EN ISO 15883-6:2026 – Washer-disinfectors – Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipmen
  • EN IEC 60601-2-22:2020 – Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • EN IEC 60601-2-57:2026 – Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
  • EN ISO 80369-1:2026 – Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements

Dispositifs de Diagnostic In-Vitro : Commission Implementing Decision (EU) 2026/2481 of 9 November 2026 :

• EN ISO 11137-1 (Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical device) passe en révision 2026