Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1 : Evaluation and testing within a risk management process

1 Domaine d'application

2 Références normatives

3 Termes et définitions

4 Principes généraux applicables à l'évaluation de la BIOCOMPATIBILITÉ des DISPOSITIFS MÉDICAUX

5 Contamination du gaz respiratoire provenant des CHEMINS DE GAZ

6 Ajustement à différents groupes de PATIENTS

7 * Détermination des limites admissibles

8 Analyse du rapport bénéfice/RISQUE

9 Évaluation de la BIOCOMPATIBILITÉ du DISPOSITIF MÉDICAL

A Justification et préconisations

B Référence aux principes essentiels

C Terminologie - Index alphabétique des termes définis

ZA Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745

Bibliographie

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