ISO/AWI 25695

Medical devices utilizing bioengineered biological substances — Application of risk management

Scope

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.