Presenting a new international standard - Application of risk management and requirements for processing practices for medical products containing viable human cells

摘要

Currently the International Organization for Standardization (ISO) is developing a new standard document (ISO 13022) which will address the requirements for risk management for medical products based on viable human cells. By definition of the relevant European Directives and Regulations products including human tissues and cells are currently considered as medicinal products in Europe, and standards are not commonly used for medicinal products in the European Community. However, there is an obvious benefit in a close coordination of the work on regu latory guidelines in Europe and internationally harmonized standards for all manufacturers of these products who are focusing on the international market. The standard ISO 13022 specifies a procedure to identify the hazards and hazardous situationsassociated with such products, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, and expected medical benefit as compared to available alternatives. It will cover viable human materials of autologous origin as well as allogeneic human material