DANSK DS/ISO 13022 PDF

This International Standard specifies requirements and guidance for processing practices and managing risks associated with viable cellular component(s) of products regulated as medicinal products, biologics, medical devices and active implantable medical devices or combinations thereof. It covers viable human materials of autologous as well as allogeneic human origin, obtained from living or deceased donors. For the manufacturer of medical products containing viable cells of human origin, this International Standard specifies procedures to be used in processing and handling, as well as those to be used to identify the hazards and hazardous situations associated with such cells, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International Standard 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. This International Standard provides requirements and guidance on risk management related to the hazards typical of medical products manufactured utilizing viable human materials such as . contamination by bacteria, moulds, yeasts or parasites, . contamination by viruses, . contamination by agents causing Transmissible Spongiform Encephalopathies (TSE), . contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions, . decomposition of the product and degradation products caused by inadequate handling, . hazard related to tumorigenic potential of the cell types used, . complications resulting from unintended physiological and anatomical consequences; this includes unintended migration of cells unwanted release of biologically active substances such as hormones and cytokines, and unintended interactions between cellular and non-cellular components of the product, . a failure of traceability, and . complications resulting from the material eliciting an unintended immunogenic reaction. For the evaluation of contamination with other unclassified pathogenic entities, similar principles may apply. Hazard related to the genetic modification are excluded from the scope of this standard and are addressed elsewhere. NOTE 1 A definition for "genetically modified" can be found in ASTM F 2312. NOTE 2 This International Standard does not specify a quality management system for the control of all stages of production of medical products as described above. This Standard is not applicable to non-viable materials of human origin.