ISO 19090:2018 PDF

Overview

ISO 19090:2018 specifies a standardized in vitro test method to measure cell migration into porous bioactive ceramics used in tissue-engineered medical products. The method mimics early in vivo behavior by placing clinically relevant porous bioactive ceramic specimens directly onto a confluent cell layer and measuring how far cells migrate into the material. The standard is intended to help manufacturers, researchers and regulators evaluate osteoconductive potential of porous bioceramics while reducing animal testing in line with the 3R principles (Replacement, Reduction, Refinement).

Key topics and technical requirements

• Scope and applicability
  • Applies to porous bioactive ceramics with cell adhesion (bone-bonding ceramics); not applicable to porous materials with low or no cell adhesion (e.g., some synthetic polymers and metals).
• Specimen dimensions and number
  • Disk-shaped specimens: 10 ± 0.2 mm diameter × 2 ± 0.1 mm thickness.
  • Minimum five specimens per comparative test (reference vs test material).
• Reference material and normalization
  • Uses a clinically accepted porous bioactive ceramic as a reference material to calculate relative migration distance, minimizing variability from cell passages, cell type, media and serum.
• Cell culture and assay procedure
  • Osteoblast-like cells are cultured to full confluency on plates; recommended lines include MG-63 and MC3T3-E1 (seeding guidance provided to obtain confluency within 3 days).
  • Deaeration, sterilization, and careful placement of specimens are required; a stainless-steel double ring is used to ensure close contact.
  • Incubation on the confluent cell layer for 3 days, followed by fixation and Giemsa staining to visualize migrated cells.
• Measurements and reporting
  • Measure the linear longest migration distance on cross-sections of stained specimens.
  • Statistical reporting includes mean and standard deviation and relative mean and standard deviation by normalization to the reference material.
  • Test report content and optional annexes (test condition results, round-robin data) are defined.

Practical applications and users

• Medical device manufacturers developing porous bone void fillers and scaffolds to demonstrate osteoconduction potential.
• Biomedical research labs and tissue-engineering groups assessing scaffold design (pore structure, surface morphology).
• Regulatory and quality teams needing standardized, reproducible in vitro data for product submission or comparative testing.
• Contract testing laboratories offering cell migration assays for biomaterials.

Related standards

• ISO 10993-5 (Biological evaluation - in vitro cytotoxicity) - normative reference for biocompatibility considerations.
• References for cell counting guidance: ISO 13366-1, ASTM F2149–01 (as cited in ISO 19090).

Keywords: ISO 19090, cell migration assay, bioactive ceramics, porous bioceramics, tissue-engineered medical products, osteoblast migration, porous scaffold testing.