ISO/TC 150/SC 7 - Tissue-engineered medical products

This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy. This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients (e.g. dialysis with TEMP components). TEMPs containing viable xenogenic cells, genetically modified cells, or cells derived from abnormal cells or tissues (e.g. cancerous tissues) are also excluded from the scope. The combination of TEMPs with medical devices, with the exception of scaffolds comprised of synthetic and/or naturally-derived (e.g. animal sourced) materials, is also excluded from the scope. NOTE International, national or regional regulations or requirements, or the Pharmacopeia also apply to specific topics covered in this document.

This document specifies test methods for the quantification of sulfated glycosaminoglycans (sGAG), one of the major extracellular matrix components in articular, meniscal, and elastic cartilages, and tissue-engineered cartilage constructs.

ISO 19090:2018 specifies the test method to be followed for measuring and documenting the cell migration ability of porous bioactive ceramic materials. ISO 19090:2018 is not applicable to porous materials that have low or no cell adhesion properties, for instance synthetic polymers and metals. These types of materials will require longer times to allow effective transfer and migration of cells from the cultured substrate to the test specimen. To minimize influences of cell passages, cell kinds, differences in cell culture consumables including culture medium and fetal bovine serum etc., the method uses a porous bioactive ceramics, which is clinically and widely used in each country, as a reference material for calculation of relative migration distance.

ISO/TR 16379:2014 has been prepared for evaluation of therapeutic courses for articular cartilage disease and summarizes results from structural evaluation of knee joint cartilage by diffusion tensor imaging, an MRI applied technology allowing non-invasive observation of soft tissue morphology in vivo. ISO/TR 16379:2014 is intended for use in areas such as regenerative medicine for knee joint cartilage disease.