Table 4.
Selection of standard test methods for the evaluation of safety of nanoparticles relevant for the nanomedicine field
| Name of standard, test method | Endpoint | Reference | Comments |
|---|---|---|---|
| Medical applications | |||
| Standard test method for analysis of hemolytic properties of nanoparticles | Biocompatibility, hemolytic properties | ASTM E2524‐08(2013) | Similar to practice F756 but modified to accommodate nanoparticulate materials |
| Standard test method for evaluation of cytotoxicity of nanoparticulate materials in porcine kidney cells and human hepatocarcinoma cells | Cytotoxicity assessment using MTT and LDH | ASTM E2526‐08(2013) | |
| Standard test method for evaluation of the effect of nanoparticulate materials on the formation of mouse granulocyte‐macrophage colonies | Immunological response | ASTM E2525‐08(2013) | |
| New test method for quantitative measurement of the chemoattractant capacity of a nanoparticulate material in vitro | Chemoattractant capacity | ASTM WK60373 | Under development |
| Other applications | |||
| Endotoxin test on nanomaterial samples for in vitro systems—Limulus amoebocyte lysate test | Contamination by endotoxin | EN ISO 29701:2010 | Last review in 2016; applies to nanomaterials intended for in vitro tests |
| 5‐(and 6)‐Chloromethyl‐2′,7′‐dichloro‐dihydrofluorescein diacetate (CM‐H2DCF‐DA) assay for evaluating nanoparticle‐induced intracellular reactive oxygen species (ROS) production in RAW 264.7 macrophage cell line | Oxidative stress | ISO/TS 19006:2016 | |
| Electron spin resonance as a method for measuring ROS generated by metal oxide nanomaterials | Oxidative stress | ISO/TS 18827:2017 | |
| In vitro MTS assay for measuring the cytotoxic effect of nanoparticles | Cytotoxicity | ISO/FDIS 19007 | Under development |
| High throughput screening method for nanoparticles toxicity using 3D cells | Cytotoxicity | ISO/AWI TS 22455 | Under development |
Note. AWI, approved work item; DIS: draft international standard; TS, technical specification.