ISO 10993-18: Chemical characterization of medical device materials

Verify the biocompatibility of your medical devices according to the ISO 10993-18 standard

First French laboratory to be ISO 17025 accredited by COFRAC* on ISO 10993-18

Caroline KURZAWA R&D Project Manager

FILAB is the first French laboratory to be ISO 17025 accredited by COFRAC for ISO 10993-18 testing. Relying on this experience, we have mastered the characterization of a large number of medical devices. Therefore we are able to assist with the whole of the ISO 10993 standard set of procedures.

ISO 10993-1 (BRA)

Assessment and testing within a risk management process

ISO 10993-18

Chemical characterization of medical device materials within a risk management process

ISO 10993-17 (TRA)

Establishment of allowable limits for leachable substances

• Why do you need to subject your medical device to an ISO 10993-18 chemical characterization before putting it on the market?

In order to test the biocompatibility of your medical device, qualitative and quantitative data must be collected on the materials that make up the devices in the context of biological safety. In the absence of such information, the material should be tested using appropriate techniques to collect data on its composition and its potential extractibles.

• What results can you expect from this analytical chemical characterization?

The objective of this analytical expertise will be to identify and quantify the soluble and insoluble elements that will potentially be released from the Medical Device.

• My Medical Device is unique, how can FILAB characterize it according to the ISO 10993-18 standard?

ISO 10993-18 standard lays the foundation for the characterization, identification and quantification of all medical devices. Considering the great diversity of medical devices, it is necessary to adapt the chemical characterization to the specificity of each one. In this sense, it is important to be supported by a laboratory with the necessary skills and equipment.

• When should ISO 10993-18 testing be performed?

The ISO 10993-18 standard tests must be performed when developing a new medical device, when changing the manufacturing process or when changing materials and/or suppliers. Please be aware that even if a material has been historically shown to be biocompatible, it must still pass the ISO 10993-18 tests.

• Simulated, exaggerated or exhaustive extraction?

Simulated extraction: An extraction with simulated use is performed to estimate the type and quantity of substances expected to be released from a medical device during its clinical use
Exaggerated Extraction: Extraction intended to result in the release of a larger number or quantity of chemical constituents than would be produced under clinical conditions of use
Exhaustive Extraction: Multi-stage extraction performed so that the amount of extracted material recovered in a later step is less than 10% of that detected, by gravimetric analysis (or by any other means), in the initial extraction step

Presentation of our offer

• Calculation of the AET

Already used in the pharmaceutical industry, the AET (Analytical Evaluation Threshold) allows the correlation of a toxicological threshold (in µg/medical device or in µg/day) to an analytical threshold (µg/mL).

The AET (Analytical Evaluation Threshold) is, according to ISO10993-18, an « analytical evaluation threshold below which the analyst is not required to identify or quantify releasable or extractable products or to report them for possible toxicological evaluation. »

• Exhaustive extraction according to ISO 10993-12

For the ISO 10993-18 chemical characterization, your medical device is immersed into neutral solvents (water, acetonitrile, ethanol, isopropanol…) according to the methods adapted to its use. At the end of this immersion, the analysis of extracts allows us to identify the chemical species that can be released from the part of the medical device, and to estimate the quantities by means of simulation solvents after application of a thermal stress

• Extractables Testing:

Soluble

Headspace analysis paired with Gas Chromatography (HS-GC/MS)
Gas Chromatography analysis (GC/MS)
Liquid Chromatography (LC-MS-QToF)
Inductively Coupled Plasma / Mass Spectrometry (ICP/MS) or Atomic Emission Spectrometry (ICP/AES)
Ion Chromatography (IC) analysis technique

Non-soluble

An offer adapted to any type of MD...

Implantable devices

FILAB is the first French laboratory to be ISO 17025 accredited by COFRAC for the ISO 10993-18 standard.

Polymer implants

orthopedic implants

Dental cement

Silicone

Hyaluronic acid gel

Non-implantable devices

Non-implantable medical devices must now comply with ISO 10993-18 even if they are not intended to be implanted in the human body.

Surgical instruments

Needles

Surgical masks

Surgical instruments

A laboratory dedicated to ISO 10993-18 chemical testing

FILAB has dedicated an entire department to the ISO 10993-18 standard. This unit is highly qualified in analytical chemistry and materials characterization. We also continue to invest in order to remain at the leading edge of analytical quality.
We have all the equipment and techniques needed for ISO 10993-18 testing: ICP, GC, LC, CI.

Medical device: ISO 10993-18, but also...

ISO 10993-12 : Sample preparation and reference materials

ISO 10993-13 : Identification and quantification of degradation products of polymeric medical devices

ISO 10993-14 : Identification and quantification of degradation products on ceramic materials

ISO 10993-19 : Physicochemical, morphological and topographical characterization of materials

ISO 10993-22 : Guidelines on nanomaterials

Customized chemical analysis

Characterization of materials

Development of analytical methods with ICHQ2 validation

Problem solving (adhesion of a coating on a material, corrosion, surface problems)

Why FILAB?

With a team of 60 people, including 5 PhDs and 7 engineers, FILAB is an independent laboratory, experienced in the analysis and surface characterization of materials. Our human scale, multi-sector know-how and ongoing investment in the latest technologies guarantee our customers reliable results, rapid response to requests and tailor-made support.

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Contact us

Do you have a question or would you like a quote? Don't hesitate to contact us. We'll get back to you as soon as possible.

Please note that our services are exclusively reserved for professionals.

The filab advantages

A highly qualified team

Responsiveness in responding to and processing requests

A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)

A complete analytical park of 5,200m²

Tailor-made support

Contact us

To respond to all these services, do not hesitate
to contact our team.

Contact us +33 (0)3 80 52 32 05 Request a quote