Approved Work Item
ISO/AWI 25695
Medical devices utilizing bioengineered biological substances — Application of risk management
Reference number
ISO/AWI 25695
Edition 1
© ISO 2025
Approved Work Item
Under development
A working group has prepared a draft.

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 194
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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