ISO 10993-1:2025

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

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Évaluation biologique des dispositifs médicaux — Partie 1: Exigences et principes généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion des risques

Languages: In English

Type: standard

ICS groups: 11.100.20 Biological evaluation of medical devices, 11.100.00 Laboratory medicine

Technical commitee: ISO/TC 194 Biological and clinical evaluation of medical devices

Registred: 18.11.2025.
In force: 18.11.2025.

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