Table 2.
List of general and “guidance‐like” documentary standards on physicochemical and biological characterization of nanomaterials
| Name of the standard, test method or guidance document | Scope | References | Comments |
|---|---|---|---|
| Medical applications | |||
| Biological evaluation of medical devices—Part 22 Guidance on nanomaterials | Physicochemical and biological evaluation | ISO/TR 10993‐22:2017 | For medical devices |
| Guidance on the determination of potential health effects of nanomaterials used in medical devices | Physicochemical and biological evaluation | Scientific Committee on Emerging and Newly Identified Health Risks (2015) | For medical devices |
| Other applications | |||
| Guidance on physicochemical characterization of engineered nanoscale materials for toxicological assessment | Physicochemical characterization | ISO/TR 13014:2012 | |
| Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials | Sample preparation, dosing methods | ISO/TR 16196:2016 | |
| Surface chemical analysis—Characterization of nanostructured materials | Overview of surface characterization methods | ISO/TR 14187:2011 | |
| Nanotechnologies—Guidance on measurands for characterizing nano‐objects and materials that contain them | Characterization of nano‐objects and materials containing nano‐objects | CEN/TS 17010:2016 | |
| Characteristics of working suspensions of nano‐objects for in vitro assays to evaluate inherent nano‐object toxicity | Characterization in the biological medium (stability, dissolution, protein corona, etc.) | ISO/TS 19337:2016 | Refers to ISO 29701 (endotoxin test) |
| Measurement technique matrix for the characterization of nano‐objects | Matrix of available measurement methods/techniques/instruments | ISO/TR 18196:2016 | |
| Compilation and description of toxicological screening methods for manufactured nanomaterials | In vitro, in vivo and ecotoxicological screening methods | ISO/TR 16197:2014 | |
| Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability | Biodurability in biological and environmental media | ISO/TR 19057:2017 | |
| Nanoparticles in powder form—Characteristics and measurements | Material specifications and the methods to measure these characteristics | ISO/TS 17200:2013 | |
| Guidelines for the characterization of dispersion stabilitya | Characterization in the biological medium | ISO/TR 13097:2013 | |
| Liquid suspension of magnetic nanoparticles—Characteristics and measurements | Material specifications and the methods to measure these characteristics | ISO/DTS 19807 | Under development |
| Separation and size fractionation for the characterization of metal‐based nanoparticles in water samples | Separation and size fractionation | ISO/AWI TR 20489 | Under development |
| Nanostructured layers for enhanced electrochemical bio‐sensing applications—Characteristics and measurements | Material specifications and the methods to measure these characteristics | ISO/AWI TS 21412 | Under development |
| Nanotechnologies—Guidance on detection and identification of nano‐objects in complex matrices | Identification of nanoparticles in complex matrices | prCEN/TS—PWI 00352012 | Under development |
| Considerations in performing toxicokinetic studies of nanomaterials | Toxicokinetics | ISO/AWI TR 22019 | Under development |
| New guide for collection and generation of environment, health, and safety information for nanomaterials and nano‐enabled products | Environment, health, and safety information | ASTM WK48313 | Under development |
Note. AWI, approved work item (ISO); CEN, adopted by European Committee for Standardization; DTS, draft technical specification; PWI, preliminary work item; TR, technical report; TS, technical specification; WK, work item.
a
Not designed specifically for nanoscale but relevant for nanomaterials.