Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)

2Scope / Description

This International Standard specifies requirements for and guidance on handling practices and risk management associated with viable cellular components of products regulated as medicinal products, biological products, medical devices, and active implantable medical devices, or a combination thereof. It covers viable human materials of both autologous and allogeneic human origin, obtained from living or deceased donors. This International Standard specifies procedures for manufacturers of medical products containing viable cells of human origin to be followed during processing and handling, as well as procedures to be followed for identifying hazards and hazardous situations associated with such cells, assessing and evaluating the resulting risks, controlling these risks, and monitoring the effectiveness of this control. Additionally, this International Standard outlines the decision-making process regarding the acceptability of residual risk by weighing the residual risk against the expected medical benefit in comparison with available alternatives.