Medical Devices: nanomaterial characterization in accordance with the ISO 10993-22 standard
You would like to carry out a characterization of nanomaterials according to the ISO 10993-22 standard
What is ISO 10993-22?
The international ISO 10993-22:2017 standard (Biological evaluation of medical devices — Part 22: Guidance on nanomaterials) describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials.
In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (ex. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.
You are looking to cooperate with a laboratory to characterize nanomaterials in accordance with the ISO 10993-22:2017 standard.
How are your Medical Devices containing nanomaterials characterized according to the ISO 10993-22 standard?
ISO/TR 10993-22:2017 covers in particular:
- characterization of nanomaterials;
- sample preparation for testing of nanomaterials;
- release of nano-objects from medical devices;
- toxicokinetics of nano-objects;
- biological evaluation of nanomaterials;
- presentation of results;
- risk assessment of nanomaterials in the context of medical device evaluation;
- biological evaluation report;
- nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.
The following aspects are excluded from the scope of ISO 10993-22:
- natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;
- intrinsic nanostructures in a bulk material;
- nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.
ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species.
FILAB uses many analytical techniques which can be used to characterize nanomaterials in accordance with the ISO 10993-22 standard:
our analysis techniques for the characterization of nanomaterials according to ISO 10993-22
ICP-AES and ICP-MS: trace analysis and chemical composition analysis of substances containing nanomaterials
XRD: structural analysis
BET: specific surface measurements
SP-ICP-MS: detection of nanoparticles
SEM-FEG-EDX: determination of the size and shape of nanoparticles
Laser Granulometry: particle count and size distribution
Helium pycnometry : density measurements
DLS: nano-emulsion measurements and stability testing of a suspension using Zeta Potential titration
The FILAB laboratory also supports you with the following services
Development and validation of analytical methods specific to nanomaterials
Nanomaterial counseling (EC 2011 cosmetics regulation EC n°1223/2009, INCO n°1169/2011, R-Nano 2012-232, 02/2012…)
FILAB is a member is the AFNOR/X457 “Nanotechnologies” commission and also has been ISO 17025 accredited according to the ISO 10993-18 standard.
With three levels of services – analysis, expertise and R&D support – FILAB assists companies from all sectors and of all sizes in overcoming their industrial challenges by sharing its technical know-how and the wealth of experience of its team with its clients.
*The scope of our accreditation covers:
- SEM-EDX measurements of the distribution of the size and shape of nanoparticles
- SP-ICP-MS determination of the size of nanoparticles
(More information available at www.cofrac.fr - accreditation n°1-1793)
FAQ
ISO 10993-22:2017 is a technical report that outlines guidance for the biological evaluation of medical devices containing or generating nanomaterials. It covers essential aspects such as nanomaterial characterization, sample preparation, release of nano-objects, toxicokinetics, risk assessment, and reporting.
The standard excludes:
- Natural or biological nanomaterials not designed for medical device use,
- Intrinsic nanostructures within bulk materials,
- Surface nanostructures unintentionally generated during part fabrication (e.g., machining marks).
Yes. Filab supports tailored sample preparation protocols specific to nanomaterial testing, and provides guidance through biological risk evaluation, and complete reporting as required by ISO standards.
ISO 10993-22 complements the series by focusing on nanomaterials. It integrates with:
- ISO 10993-1 (Overall biological evaluation),
- ISO 10993-17 (Toxicological risk assessment),
- ISO 10993-18 (Chemical characterization).
Nanomaterials pose distinct challenges, such as:
- Their high surface area-to-volume ratio, impacting reactivity and behavior,
- Complex dispersion and aggregation issues,
- Analytical sensitivity required for trace-level detection,
A COFRAC-accredited lab like Filab ensures:
- Full compliance with ISO/IEC 17025 quality standards,
- Rigorous method validation with traceable and auditable results,
- High technical competence and reliability for regulatory submissions and audits.
ISO 10993-22 is not always mandatory but highly recommended when a device contains or generates nanomaterials—particularly if there is a risk of release. It supports regulatory risk management and strengthens biological evaluation dossiers.
Absolutely. Filab also provides analytical method development and validation for nanomaterials, regulatory consulting on nanomaterial regulations, literature reviews, staff training, and integration of complementary services such as ISO 10993-18 chemical characterization.
