Ultimas normas …
- ISO 10993-7:2026 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO 14155:2026 Clinical investigation of medical devices for human subjects — Good clinical practice
- ISO 20417:2026 Medical devices — Information to be supplied by the manufacturer
- ISO 10993-6:2026 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- IEC 60601-2-22:2019+AMD1:2026 CSVMedical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-2-91:2026 PRVMedical electrical equipment – Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment
- ISO 80601-2-61:2026 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 80601-2-67:2026 Medical electrical equipment – Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
- ISO 80601-2-69:2026 Medical electrical equipment – Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
- ISO 80601-2-90:2026 Medical electrical equipment – Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
- IEC PAS 63621:2026 Artificial intelligence enabled medical devices – Data management
- IEC 62304 Edition 2.0 Stage code: ACD Forecast publication date 2028-10-26
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
- MDCG 2021-24 rev.1 (Abr 2026) Guidance on classification of medical devices
- MDCG 2021-12 rev.2 (abr 2026) FAQ on the European Medical Device Nomenclature (EMDN)
- Q&A rev.2 Q&A Obligation to inform in case of interruption or discontinuation of supply
LISTA DE NORMAS ARMONIZADAS MDR
ABRIL 2026
LISTA DE NORMAS ARMONIZADAS IVDR
ENERO 2026
