ISO/AWI 25695

Projet

Un groupe de travail a préparé un projet.

Résumé

This document specifies requirements and guidance on risk management related to the hazards typical of medical devices utilizing bioengineered biological substances, including risk management process, risk evaluation, risk control, residual risk evaluation, evaluation of overall residual risk acceptability, and production and post-production information system. The main risk categories of medical devices include structural risks of bioengineered biological substances; risks of impurities, contaminants, and additives; immunogenicity risks; and other hazards and risks.

Informations générales

État actuel
: Projet

Stade
: Nouveau projet enregistré au programme de travail du TC/SC [20.00]
Edition
: 1
Comité technique :
ISO/TC 194
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