ISO/WD 25289
Resumen
This document specifies (i) characterization parameters and methods used to qualify a bronchial air-liquid interface (ALI) microphysiological system (MPS) for a declared context of use (CoU), and (ii) minimum verification/quality control checks (e.g., lot/batch verification) to confirm that manufactured MPS components continue to meet the qualified performance. It does not establish a full quality management system (QMS) or manufacturing process validation requirements; sampling plans and test frequencies are to be defined by the manufacturer/user and reported. This document covers verification of the bronchial MPS platform. It does not standardize specific experimental test methods. This document provides performance-based guidance for bronchial airway MPS/Organ-on-chip (OoC) with microfluidic control using ALI, where dynamic microenvironmental parameters (e.g., flow/shear, cyclic strain) and multi-compartment architectures with integrated sensing introduce additional sources of variability. Conventional static ALI cultures conducted in standard multi-well plates without a microengineered platform are outside the scope of this document.
Informaciones generales
-
Estado: En desarrolloEtapa: Cierre del periodo de observaciones [20.60]
-
Edición: 1
-
Comité Técnico :ISO/TC 276/SC 2
- RSS actualizaciones
