ISO 19090:2018 PDF

Scope: The document specifies the test method to be followed for measuring and documenting the cell migration ability of porous bioactive ceramic materials. This document 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 19090:2018 Referenced Document

ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 13366-1:2008 Milk - Enumeration of somatic cells - Part 1: Microscopic method (Reference method)

2018 ISO 19090:2018 Tissue-engineered medical products - Bioactive ceramics - Method to measure cell migration in porous materials