Medical Devices: nanomaterial characterization in accordance with the ISO 10993-22 standard
Would you like to characterise nanomaterials according to ISO 10993-22?
What is ISO 10993-22?
The International Standard ISO/TR 10993-22: 2017 (Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials) describes the aspects to be considered when biologically evaluating medical devices that contain or are composed of nanomaterials.
These guidelines may also be applied to the evaluation of nano-objects generated as degradation or wear products, or resulting from mechanical processing (for example, in situ grinding or polishing of medical devices) of medical devices or their components manufactured without nanomaterials.
Are you looking for a laboratory capable of supporting your nanomaterial characterisation according to ISO 10993-22:2017?
What is the scope of application of ISO 10993-22?
ISO/TR 10993-22:2017 covers, in particular:
- the characterization of nanomaterials;
- sample preparation for tests conducted on nanomaterials;
- the release of nano-elements from medical devices;
- the toxicokinetics of nano-elements;
- the biological evaluation of nanomaterials;
- the presentation of results;
- the assessment of risks associated with nanomaterials in the context of the evaluation of medical devices;
- the biological evaluation report;
- nanostructures on the surface of a medical device that have been deliberately produced during the engineering, manufacturing or processing stages of a medical device.
The following aspects are excluded from the scope of ISO 10993-22:
- natural and biological nanomaterials that have not been designed, manufactured or processed for use in a medical device;
- intrinsic nanostructures of a bulk material;
- nanostructures on the surface of a medical device that were generated as an unintended by-product during the engineering, manufacturing or processing stages of a medical device.
ISO/TR 10993-22:2017 is intended to provide a general framework and highlight important aspects to consider when evaluating the safety of medical devices composed of, containing and/or generating nanomaterials. It also identifies some common pitfalls and obstacles encountered during tests on nanomaterials compared with tests performed on bulk materials or small molecular chemical species
our analytical techniques for the characterization of nanomaterials according to ISO 10993-22
ICP-AES and ICP-MS : trace and chemical composition analysis of a nanomaterial-based product
XRD : structural analysis
BET : specific surface area measurement
SP-ICP-MS : nanoparticle detection
FEG-SEM-EDX: determination of nanoparticle size and shape
Laser diffraction particle size analysis : particle counting and particle size distribution
Helium pycnometry : density measurement
DLS : nanoemulsion measurement and suspension stability study by titration of the Zeta Potential.
Our analytical services according to the various ISO 10993 standards
our expertise
FILAB laboratory also supports you with the following services
Development and validation of analytical methods specific to nanomaterials
Literature and regulatory review of nanomaterials
Regulatory consulting for nanomaterials (2011 EC Recommendation, EC Cosmetics Regulation No. 1223/2009, INCO Regulation No. 1169/2011, R-Nano (2012-232, 02/2012)...)
The rise of nano-characterization according to ISO 10993-19 and -22 standards
Discover our press articleTo support you under the best possible conditions, FILAB laboratory is approved for the Research Tax Credit (CIR). FILAB is also a member of the AFNOR/X457 “Nanotechnologies” committee. FILAB is notably ISO/IEC 17025 accredited by COFRAC according to ISO 10993-18.
Through its three levels of service – analysis, expertise and R&D support – FILAB assists companies of all sectors and sizes in resolving their industrial challenges by providing clients with the expertise and experience of its team.
FAQ
ISO 10993-22 analysis aims to assess the specific risks associated with nanomaterials used in medical devices. It is based on in-depth physicochemical characterization (size, particle size distribution, morphology, specific surface area and state of agglomeration) to support the biological evaluation.
Nanomaterials may exhibit biological behaviours that differ from those of conventional materials. Nanomaterial analysis of medical devices helps identify the parameters likely to influence toxicity, biodistribution or interaction with tissues.
ISO 10993-22 analysis applies to metallic, oxide, polymeric or composite nanoparticles, whether or not integrated into a matrix, whenever they may be released or come into contact with the patient.
An ISO 10993-22 analysis laboratory uses complementary techniques such as particle size analysis (DLS, LD), electron microscopy (SEM, TEM), surface analysis (BET, zeta potential) and chemical characterization to describe nanomaterials precisely.
ISO 10993-18 covers the overall chemical characterization of materials, whereas ISO 10993-22 is specifically dedicated to assessing risks associated with nanomaterials by taking into account their specific physical and structural properties.
An ISO 10993-22 assessment can be carried out as early as the design phase, when modifying a formulation, or to support a regulatory submission, in order to secure the biological evaluation associated with nanomaterials.
Nanomaterial characterization requires advanced analytical expertise and dedicated equipment. A nanomaterials and medical device testing laboratory ensures the reliability of the data required for risk assessment in accordance with ISO 10993-22.
The analysis result in detailed reports describing the physicochemical properties of the nanomaterials, interpreted within the framework of the ISO 10993-22 assessment to support biological and regulatory evaluation.
To obtain a quotation for ISO 10993-22 characterization, you need to complete the online form so that our team can contact you.
The quotation is generally sent within 24 to 48 hours after receipt of the necessary information.
