ISO/AWI 25695

En desarrollo

Un grupo de trabajo ha preparado un borrador.

Resumen

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.

Informaciones generales

Estado
: En desarrollo

Etapa
: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
Edición
: 1
Comité Técnico :
ISO/TC 194
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