Medical Devices: nanomaterial characterization in accordance with the ISO 10993-22 standard

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 includes considerations on the:

– 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 are excluded from this document:

– 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:

    • ICP-AES and ICP-MS: trace analysis and chemical composition analysis of substances containing nanomaterials
    • SEM-FEG-EDX: determination of the size and shape of nanoparticles
    • XRD: structural analyses
    • Laser Granulometry: particle count and size distribution
    • BET: specific surface measurements
    • Helium pycnometry : density measurements
    • SP-ICP-MS: detection of nanoparticles
    • DLS: nano-emulsion measurements and stability testing of a suspension using Zeta Potential titration 

    FILAB laboratory can also provide the following services…

    • Development and validation of analytical methods specific to nanomaterials
    • Physicochemical characterization in accordance with the ISO 10993-18:2020 standard
    • Container/contents interaction testing
    • Literature and regulatory review
    • Analytical training
    • 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)

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thank you !

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