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Medical Device characterization in accordance with the ISO 10993-19 standard
FILAB laboratory is able to assist you in characterizing your medical devices in accordance with the ISO 10993-19 standard
The ISO 10993-19 standard provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, physicochemical, morphological and topographical (PMT) properties of materials in finished medical devices. PMT parameters play an important role in evaluating the biocompatibility and the clinical efficiency of medical devices.The ISO 10993-19 standard therefore states which properties are to be taken into consideration when characterizing the PMT parameters of materials containing polymers, metals, alloys, ceramics, and natural macromolecules.With support from a partner laboratory, FILAB is able to assist you in evaluating the biocompatibility of your Medical Devices by conducting the following tests :
Our tests
Chemical characterization in accordance with the ISO 10993-19 standard
Degradation testing in accordance with the ISO 10993-13, ISO 10993-14 and ISO 10993-15 standards
Chemical characterization in accordance with the ISO 10993-18 standard
Nanomaterial characterization in accordance with the ISO 10993-22 standard
We are also able to provide the following services :
Our services
Cytotoxicity testing in accordance with the ISO 10993-5 standard
Skin irritation testing in accordance with the ISO 10993-10 standard
Toxicological evaluations of leachable substances in accordance with the ISO 10993-17 standard
The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.
Les + FILAB
Une équipe hautement qualifiée
Une réactivité de réponse et de traitement des demandes
Un laboratoire accrédité COFRAC ISO 17025
(Portées disponibles sur www.cofrac.com - N° accréditation : 1-1793)
Un parc analytique complet de 2100m²
Un accompagnement sur-mesure
Why choosing an ISO 10993-19 certified laboratory?
Choosing an ISO 10993-19 certified laboratory is important for several reasons: Compliance with Regulatory Requirements: Regulatory agencies such as the European Medicines Agency (EMA) require medical device manufacturers to provide comprehensive data on the physico-chemical, morphological, and topographical characterization of materials used in their devices. Working with an ISO 10993-19 certified laboratory can help ensure that your testing meets these regulatory requirements. Expertise and Experience: An ISO 10993-19 certified laboratory has the expertise and experience necessary to conduct thorough material characterization testing. The lab personnel are trained in the specific techniques and methods required for these tests, and they have a deep understanding of the relevant regulations and guidelines. Quality Assurance: An ISO 10993-19 certified laboratory must adhere to stringent quality assurance and quality control standards. This means that the lab follows established protocols for sample preparation, testing, and data analysis, ensuring that the results are accurate, reproducible, and reliable. Risk Mitigation: Failure to adequately characterize the materials used in a medical device can lead to product recalls, safety issues, and legal liability. Choosing an ISO 10993-19 certified laboratory can help mitigate these risks by ensuring that your device materials are thoroughly tested and meet all applicable safety standards.
What are the mandatory clauses of ISO 10993-19 to be met?
ISO 10993-19 is a standard that provides guidance on the physico-chemical, morphological, and topographical characterization of materials used in medical devices. The standard outlines several mandatory clauses that must be met to ensure that materials are thoroughly characterized and safe for use in medical devices. These include: Sample Preparation: This clause outlines the requirements for preparing samples for testing, including the size, shape, and number of samples required. Identification of Materials: This clause requires the identification of all materials used in the device, including any additives or impurities that may be present. Physico-Chemical Properties: This section outlines the tests required to evaluate the physico-chemical properties of the materials, such as solubility, pH, and viscosity. Morphological and Topographical Characterization: This clause requires the evaluation of the morphology and topography of the materials, including their surface area, porosity, and roughness. Surface Properties: This clause outlines the requirements for evaluating the surface properties of the materials, including surface tension, contact angle, and surface energy. Chemical Characterization: This clause requires the identification and quantification of chemical substances present in the device, including any additives or impurities that may be introduced during the manufacturing process.Biological Evaluation: This clause requires manufacturers to conduct in vitro and/or in vivo biological evaluations to assess the biocompatibility of the materials.
What are the main methods used for medical device characterization within ISO 10993-19?
ISO 10993-19 outlines several methods for the characterization of materials used in medical devices. These methods can be broadly categorized into three groups: physico-chemical characterization, morphological characterization, and topographical characterization. Some of the main methods used in each of these areas include: Physico-Chemical Characterization:Fourier Transform Infrared (FTIR) SpectroscopyThermogravimetric Analysis (TGA)Differential Scanning Calorimetry (DSC)X-ray Photoelectron Spectroscopy (XPS)Atomic Absorption Spectroscopy (AAS)Inductively Coupled Plasma Mass Spectrometry (ICP-MS)Gas Chromatography-Mass Spectrometry (GC-MS) Morphological Characterization:Scanning Electron Microscopy (SEM)Transmission Electron Microscopy (TEM)Atomic Force Microscopy (AFM)Confocal Laser Scanning Microscopy (CLSM)Light Scattering TechniquesMechanical Profiling Topographical Characterization:Contact Angle GoniometrySurface Roughness MeasurementsScanning Probe Microscopy (SPM)Optical Profilometry Overall, these methods are used to evaluate various aspects of a material's properties, such as chemical composition, thermal stability, morphology, surface topography, and wettability. The results of these tests are critical for ensuring that the materials used in medical devices are safe, effective, and meet all regulatory requirements.
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Laboratory biocompatibility tests in accordance with ISO 10993
Definition
What is biocompatibility?
Biocompatibility is the ability of materials to perform a given function without having undesirable effects in the biological environment (degradation, interference, etc.) in which the material in question is used. A material must be biocompatible if it is used in the design of medical devices that will be in contact with a biological environment.The biocompatibility of a material does not necessarily depend on the functional purpose of the medical devices that will include this material. Biocompatibility depends above all on the contact time of the material with biological tissue, but also on the type of contact and its ability to fulfil its function. An example of a biocompatible material is titanium, a metallic material used in medical devices such as implants (bone substitutes, prostheses, etc.), for which FILAB performs analyses in accordance with the ISO 5832-3 standard.
How is the biocompatibility of a material assessed in accordance with ISO 10993?
In an evolving regulatory context, the harmonised standards in the NF EN ISO 10993 series are the current benchmarks for the biological evaluation of medical devices and the biocompatibility of materials.
Where to start?
First step :
ISO 10993-1: Evaluation and testing by a toxicologist (FILAB partner network). This first step will enable you to find out what steps need to be taken to check the suitability of the materials used in your medical device to perform its functions without undesirable effects in the biological environment (degradation, interference).
Once this stage has been completed, FILAB will help you with the rest!
ISO 10993-12 : Preparation of samples and reference materialsISO 10993-18 : Chemical characterisation of materials
ISO 10993-19 : Physicochemical, morphological and topographical characterisation of materials
ISO 10993-13 : Identification and quantification of degradation products from polymer-based medical devicesISO 10993-14 : Identification and quantification of degradation products from ceramicsISO 10993-15 : Identification and quantification of degradation products from metals and alloys
ISO 10993-22 : Caractérisation des nanomatériaux
*COFRAC accreditations
ISO 10993 standard in detail
ISO 10993 comprises the following parts, presented under the general title "Biological Evaluation of Medical Devices".
ISO 10993-1
Assessment and testing
ISO 10993-2
Animal protection requirements
ISO 10993-3
Genotoxicity, carcinogenicity and reproductive toxicity tests
ISO 10993-4
Choice of tests for interactions with blood
ISO 10993-5
In vitro cytotoxicity tests
ISO 10993-6
Tests on local effects after implantation
ISO 10993-7
Ethylene oxide sterilisation residues
ISO 10993-8
Selection and qualification of reference materials used for biological tests
ISO 10993-9
Framework for identifying and quantifying potential degradation products
ISO 10993-10
Irritation and delayed hypersensitivity tests
ISO 10993-11
Systemic toxicity tests
ISO 10993-12
Preparation of samples and reference materials
ISO 10993-13
Identification and quantification of degradation products in polymer-based medical devices
ISO 10993-14
Identification and quantification of ceramic degradation products
ISO 10993-15
Identification and quantification of degradation products from metals and alloys
ISO 10993-16
Design of toxicokinetic studies of degradation products and leachable substances
ISO 10993-17
Establishment of permissible limits for releasable substances using relative risk assessment
ISO 10993-18
Chemical characterization of materials
ISO 10993-19
Physicochemical, morphological and topographical characterisation of materials
ISO 10993-20
Principles and methods for immunotoxicology testing of medical devices
ISO 10993-22
Characterization of nanomaterials
Our FAQ
What is the biocompatibility classification scheme?
David Williams, a well-known expert in the field of biomaterials, has proposed a classification scheme for biocompatibility based on three subgroups of applications. These subgroups are:Implantable materials: These are materials that are intended to be implanted within the body, such as orthopedic implants, pacemakers, and stents. Biocompatibility for these materials is critical, as they will be in contact with living tissue for extended periods of time.External communicating devices: These are devices that are used externally to communicate with the body, such as insulin pumps or electrodes used for neurological monitoring. These devices do not typically come into direct contact with living tissue, but they must still be biocompatible to avoid adverse reactions.Materials used in contact with blood: These are materials that come into contact with blood, such as catheters, vascular grafts, and dialysis membranes. Biocompatibility for these materials is important to ensure that they do not cause clotting or other adverse reactions in the bloodstream.Overall, Williams' classification scheme recognizes the importance of biocompatibility in different application areas and highlights the need for specific testing protocols and standards for each subgroup. By understanding the specific requirements for biocompatibility in different applications, researchers and manufacturers can develop materials and devices that are safe and effective for their intended use.
Why is it important to use biocompatible materials?
Using biocompatible materials and conducting rigorous biocompatibility testing helps to minimize the risks associated with medical devices. It ensures that devices are suitable for their intended use, reducing the likelihood of adverse reactions and complications for patients. Biocompatibility testing provides valuable data and evidence that allows manufacturers to make informed decisions regarding the materials used in their devices and helps regulatory authorities assess the safety and effectiveness of these products before they are made available to the public.Incorporating biocompatible materials and conducting thorough biocompatibility testing, such as those outlined by ISO 10993 testing lab, is vital to ensure the safety and efficacy of medical devices. These practices play a crucial role in safeguarding patient well-being and enhancing the overall quality of healthcare.
Why should you choose an iso 10993 certified testing lab for your analysis?
Choosing an ISO 10993 certified testing lab for medical device analysis is important for several reasons:Compliance with regulatory requirements: Regulatory bodies such as the FDA require that medical devices undergo biocompatibility testing according to ISO 10993 standards. Choosing a certified testing lab ensures that your tests are performed according to established guidelines and that your data will be accepted by regulators.Expertise and experience: Certified testing labs have the expertise and experience necessary to perform biocompatibility testing accurately and efficiently. They are knowledgeable about the latest testing methods and technologies, and they can provide guidance on test selection and interpretation of results.Consistent quality: Certified testing labs adhere to rigorous quality management systems, ensuring that their testing processes and procedures are standardized and consistent. This minimizes the risk of errors or deviations in testing and ensures that your results are reliable and reproducible.Access to specialized equipment and facilities: Biocompatibility testing often requires specialized equipment and facilities, such as cleanrooms or analytical instruments. Certified testing labs have access to these resources, which may not be available in-house or at non-certified labs.Cost-effectiveness: Working with a certified testing lab can be cost-effective in the long run. Certified labs may offer bundled testing packages or discounts for repeat testing, and they may be able to provide additional services beyond biocompatibility testing.
Les Filab
Une équipe hautement qualifiée
Une réactivité de réponse et de traitement des demandes
Un laboratoire accrédité COFRAC ISO 17025
(Portées disponibles sur www.cofrac.com - N° accréditation : 1-1793)
Un parc analytique complet de 2100m²
Un accompagnement sur-mesure
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Chemical characterization of materials in accordance with ISO 10993-18
As a manufacturer, you want to carry out a chemical characterisation of your materials in accordance with the ISO 10993-18 standard.
ISO 10993-18 and medical devices
ISO 10993-18 describes a process for identifying a material and determining and quantifying its chemical makeup. The chemical characterization of a material allows us to :
Better understand a material from a biological safety point of view (Biocompatibility testing in accordance with the ISO 10993 set)
Testing for leachable substances from Medical Devices
Measuring the amount of material used in medical devices in the context of double or multisource
How can you carry out effective chemical characterisation of your materials in accordance with ISO 10993-18?
Chemical characterization of a material used in medical devices must be representative of the chemical nature, the physical form and the clinical exposure duration and the duration in particular must be calculated based on toxicological risk factors.The success or failure of chemical characterization depends on collaboration and the exchange of information between characterization specialists, analytical specialists and toxicologists. It is important to note that the ISO 10993-18 regulation does not involve the identification or the quantification or degradation products from polymer-based, ceramic or metallic materials as these aspects are covered by other regulations relating to Medical Devices.
The FILAB laboratory is ISO 17025 accredited by COFRAC for chemical characterization of materials in accordance with ISO 10993-18
Why call on FILAB for the chemical characterisation of your materials in accordance with the ISO 10993-18 standard?
For over ten years, FILAB laboratory has been developing a wide skillset in analytical chemistry and material characterization and has been collaborating with toxicology experts to provide the best characterization services for your biomaterials :
Chemical characterisation in accordance with iso 10993-18
Calculation of AET
Research and determination of organic residues by GC/MS, LC, HS/GCMS
Identification of impurities by LC-QTOF (database of over 1000 substances)
Sampling of reference materials in accordance with ISO 10993-12
Research and determination of organic and inorganic residues by ICP and CLI...
FDA guideline for ISO 10993-18
What's about FDA biocompatibility ISO 10993-18 ?
Additional tests may be required by the FDA (American Food and Drug Administration).
The FILAB laboratory also assists medical device manufacturers with other biocompatibility-related tests, or for any other analyses linked to the development or optimisation of a device:
Our services dedicated to medical devices
Identification and quantification of medical device degradation products - ISO 10993-13, ISO 10993-14, ISO 10993-15
Physicochemical, morphological and topographical characterisation of materials in accordance with ISO 10993-19
Analysis of cleaning residues in accordance with ISO 19227
Problem solving using failure analysis: fracture, adhesion, corrosion, etc.
Analysis of ethylene oxide sterilisation residues in accordance with ISO 10993-7
Analysis of nanomaterials in DM according to ISO 10993-22
R&D support: custom chemical analysis, materials and surface characterisation, analytical development
Les + FILAB
Une équipe hautement qualifiée
Une réactivité de réponse et de traitement des demandes
Un laboratoire accrédité COFRAC ISO 17025
(Portées disponibles sur www.cofrac.com - N° accréditation : 1-1793)
Un parc analytique complet de 2100m²
Un accompagnement sur-mesure
FAQ
Is chemical characterization of medical device mandatory for approval ?
Yes, chemical characterization of medical devices is usually mandatory for regulatory approval in most countries. Regulatory agencies such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) require manufacturers to provide detailed information on the chemical composition of their medical devices as part of the regulatory submission process. The objective of this requirement is to ensure that the device materials and any additives or impurities are safe for their intended use and do not pose a risk to human health. The regulatory agencies review the results of chemical characterization studies to determine if the device meets safety and efficacy standards before granting approval for marketing and distribution. The specific requirements for chemical characterization may vary depending on the type of device, its intended use, and the regulatory agency responsible for reviewing the submission. However, in general, manufacturers must provide comprehensive data on the chemical substances present in the device, including any potential leachables or extractables that could be released into the body or surrounding environment. Overall, chemical characterization is an essential step in the regulatory approval process for medical devices, and manufacturers must ensure that they meet all applicable requirements before submitting their devices for review.
How is performed chemical characterization of medical device ?
Chemical characterization of medical devices is a critical step in ensuring their safety and efficacy. It involves the identification and quantification of the chemical substances present in the device, including any additives or impurities that may be introduced during the manufacturing process. The process typically involves a combination of analytical techniques, such as chromatography, mass spectrometry, and spectroscopy. These techniques can be used to identify and measure the levels of various chemical compounds, such as monomers, plasticizers, stabilizers, and other additives. In addition, the testing may involve evaluation of the potential for leaching of chemicals from the device into body tissues or fluids. This may involve testing the device under simulated conditions that mimic actual use, as well as analyzing extracted solutions using the same analytical techniques previously mentioned. Overall, thorough chemical characterization is an essential component of medical device development and regulatory submission, as it provides critical information for evaluating the safety, efficacy, and quality of the device.
What is the difference between material characterization and chemical characterization of medical device ?
Chemical characterization and material characterization are both important aspects of medical device development, but they differ in their focus and scope. Chemical characterization focuses on the identification and quantification of chemical substances present in the device, including any additives or impurities that may be introduced during the manufacturing process. The goal is to understand the nature and quantity of chemicals that may be released from the device into the body or surrounding environment, and to ensure that they do not pose a risk to human health. Material characterization, on the other hand, focuses on the physical and mechanical properties of the materials used in the device. This includes evaluating the strength, durability, biocompatibility, and other characteristics of the materials to ensure that they are suitable for their intended use. While there is some overlap between these two areas of characterization, they are distinct in their focus and methods. Chemical characterization typically involves analytical techniques such as chromatography and mass spectrometry to identify and measure the levels of various chemical compounds, while material characterization may involve mechanical testing, microscopy, and other methods to evaluate physical properties.
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Identification and quantification of degradation products from polymer-based Medical Devices in accordance with the ISO 10993-13 standard
Your needs : to study degradation products from your polymer-based medical devices in accordance with the ISO 10993-13 standard
The ISO 10993-13 standard is part of the ISO 10993 set implemented for the assessment of the biocompatibility of medical devices. These biocompatibility tests are conducted to verify the aptitude of materials to carry out a given function without having undesired side effects.The ISO 10993-13 standard specifies the relevant regulations surrounding the identification and quantification of degradation products from polymer-based Medical Devices.Degradation products analyzed following the ISO 10993-13 may be the result of chemical alteration.Are you looking to cooperate with a reliable and reactive laboratory for assistance in analyzing your medical devices in accordance with the ISO 10993-13 standard ? Feel free to contact us !
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Our solution : to assist Medical Device producers in testing the biocompatibility in accordance with the ISO 10993-13 standard for the identification and quantification of degradation products
For over 10 years, FILAB laboratory have been developing a diverse analytical skillset applied to chemical analysis and material characterization. FILAB laboratory is equipped with a cutting-edge analytical fleet spread over 2100m² of laboratory space to be able to provide Medical Device producers with services fulfilling their criteria in terms of product compliance relating to the ISO 10993-13 standard.Whatever your biomaterial, you can call upon an expert laboratory for the chemical characterization of your materials and the assessment of the biocompatibility of your Medical Devices :
our expertise
Chemical characterization of materials in accordance with the ISO 100993-18 standard
Characterization of Medical Devices containing nanomaterials in accordance with the ISO 10993-22 standard
Sample preparation in accordance with the ISO 10993-12 standard
Identification and quantification of degradation products from polymer-based medical devices in accordance with the ISO 10993-13 and ISO 10993-14 standards
FILAB is also able to provide the following services :
Our services
Biocompatibility testing in accordance with the ISO 10993 set (ISO 10993-18 / ISO 10993-12 / ISO 10993-14 / ISO 10993-15 / ISO 10993-19 / ISO 10993-22)
Problem solving : non-compliance, ruptures, adhesive problems, corrosion…
R&D support : custom chemical analysis, material characterization, surface characterization, analytical development
Procedure validation : cleaning (ISO 19227), surface treatment
The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.For more information about or analytical services for your Medical Devices in accordance with the ISO 10993-13 standard, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05.
What is the biocompatibility classification scheme?
David Williams, a well-known expert in the field of biomaterials, has proposed a classification scheme for biocompatibility based on three subgroups of applications. These subgroups are: Implantable materials: These are materials that are intended to be implanted within the body, such as orthopedic implants, pacemakers, and stents. Biocompatibility for these materials is critical, as they will be in contact with living tissue for extended periods of time. External communicating devices: These are devices that are used externally to communicate with the body, such as insulin pumps or electrodes used for neurological monitoring. These devices do not typically come into direct contact with living tissue, but they must still be biocompatible to avoid adverse reactions. Materials used in contact with blood: These are materials that come into contact with blood, such as catheters, vascular grafts, and dialysis membranes. Biocompatibility for these materials is important to ensure that they do not cause clotting or other adverse reactions in the bloodstream. Overall, Williams' classification scheme recognizes the importance of biocompatibility in different application areas and highlights the need for specific testing protocols and standards for each subgroup. By understanding the specific requirements for biocompatibility in different applications, researchers and manufacturers can develop materials and devices that are safe and effective for their intended use.
Why is it important to use biocompatible materials?
Using biocompatible materials and conducting rigorous biocompatibility testing helps to minimize the risks associated with medical devices. It ensures that devices are suitable for their intended use, reducing the likelihood of adverse reactions and complications for patients. Biocompatibility testing provides valuable data and evidence that allows manufacturers to make informed decisions regarding the materials used in their devices and helps regulatory authorities assess the safety and effectiveness of these products before they are made available to the public. Incorporating biocompatible materials and conducting thorough biocompatibility testing, such as those outlined by ISO 10993 testing lab, is vital to ensure the safety and efficacy of medical devices. These practices play a crucial role in safeguarding patient well-being and enhancing the overall quality of healthcare.
Why should you choose an iso 10993 certified testing lab for your analysis?
Choosing an ISO 10993 certified testing lab for medical device analysis is important for several reasons:Compliance with regulatory requirements: Regulatory bodies such as the FDA require that medical devices undergo biocompatibility testing according to ISO 10993 standards. Choosing a certified testing lab ensures that your tests are performed according to established guidelines and that your data will be accepted by regulators.Expertise and experience: Certified testing labs have the expertise and experience necessary to perform biocompatibility testing accurately and efficiently. They are knowledgeable about the latest testing methods and technologies, and they can provide guidance on test selection and interpretation of results.Consistent quality: Certified testing labs adhere to rigorous quality management systems, ensuring that their testing processes and procedures are standardized and consistent. This minimizes the risk of errors or deviations in testing and ensures that your results are reliable and reproducible.Access to specialized equipment and facilities: Biocompatibility testing often requires specialized equipment and facilities, such as cleanrooms or analytical instruments. Certified testing labs have access to these resources, which may not be available in-house or at non-certified labs.Cost-effectiveness: Working with a certified testing lab can be cost-effective in the long run. Certified labs may offer bundled testing packages or discounts for repeat testing, and they may be able to provide additional services beyond biocompatibility testing.
Our services
Study of degradation products in your medical devices according to ISO 10993-15
With regard to the materials used in the manufacture of medical devices, they can generate degradation products when exposed to their biological environment.In this context, it is important to ensure their level of tolerability for the safety of certain medical devices. To do this, investigations must be carried out to identify and quantify them.The ISO 10993-15 standard gathers the different general principles for the evaluation and design of degradation studies of materials used in Medical Devices. "Degradation" here means "decomposition of the material". It deals only with degradation products from metals and alloys.The method of evaluating degradation varies according to several elements:the nature of the material studied,the medical deviceits anatomical location
FILAB laboratory can assist you in the identification and quantification of degradation products in your medical devices according to ISO 10993-15
Two standards complementary to ISO 10993-15 and specific to non-resorbable materials describe these conditions:ISO 10993-13: Identification and quantification of degradation products of polymer-based medical devicesISO 10993-14: Identification and quantification of degradation products of ceramicsFILAB can assist you in the analysis of your medical devices, including the following tests Chemical characterization according to ISO 10993-19 and ISO 10993-18Characterization of nanomaterials according to ISO 10993-22HCT and TOC analysis according to ISO 19227Our human size, our permanent investments and our knowledge of the medical devices sector guarantee our customers a reliability of the results, a fast treatment of the requests and a tailor-made support of their needs.
Our services
Identification and quantification of degradation products according to ISO 10993-9
Materials used in the manufacture of medical devices can generate degradation products when exposed to their biological environment. In this context, it is important to ensure their level of tolerability for the safety of certain medical devices, by conducting investigations to identify and quantify them.The ISO 10993-9 standard brings together the different general principles for the evaluation and design of degradation studies of materials used in Medical Devices - "degradation" meaning here "decomposition of the material". It deals only with degradation products resulting from chemical alteration of the device in the human body, not from mechanical stress or wear. Also, it is important to note that this standard does not refer to the extractable and leachable compounds studied in Part 18 of ISO 10993. The method of assessing degradation will vary depending on the nature of the material being studied, the medical device and its anatomical location.
FILAB laboratory assists you in the identification and quantification of degradation products in your medical devices according to ISO 10993-9Three standards complementary to ISO 10993-9 and specific to non-resorbable materials describe these conditions:ISO 10993-13: Identification and quantification of degradation products of polymer-based medical devicesISO 10993-14: Identification and quantification of degradation products of ceramicsISO 10993-15: Identification and quantification of degradation products from metals and alloysFILAB provides more comprehensive support for the biocompatibility assessment of your devices, including the following tests Chemical characterization according to ISO 10993-19Chemical characterization according to ISO 10993-18Characterization of nanomaterials according to ISO 10993-22Our human size, our permanent investments and our knowledge of the medical devices sector guarantee our customers reliable results, rapid processing of requests and tailor-made support for their needs.
Les + FILAB
Une équipe hautement qualifiée
Une réactivité de réponse et de traitement des demandes
Un laboratoire accrédité COFRAC ISO 17025
(Portées disponibles sur www.cofrac.com - N° accréditation : 1-1793)
Un parc analytique complet de 2100m²
Un accompagnement sur-mesure
Our services
Laboratory for particle size distribution analysis according to ISO 17025
Your needs: analysis of the particle size distribution of your products
In what context do you use particle size distribution analysis of your products?
As part of the quality control of your production batches before they are placed on the market, you may be required to determine certain characteristics of your raw materials and finished products.
It is in this context that the FILAB laboratory brings you its expertise for the required tests on raw materials, APIs, Medical Devices and finished products, including particle size distribution analysis.
Our solutions: COFRAC ISO 17025 accredited particle size distribution analysis
Analysis techniques
For several years we have dedicated a set of specific techniques to the analysis of powders in the pharmaceutical industry, whether they are metallic, ceramic, organic or mineral.
Thus, we have been awarded the COFRAC ISO 17025 accreditation for particle size distribution analysis by laser granulometer (dry or liquid method) according to PE 2.9.31 and ISO 13320.
This accreditation completes our COFRAC accreditations for Medical Devices:
Particle counting by Optical Microscope according to the current standards: ISO 19227, ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
Particle identification by SEM-EDX and µ-IRTF according to the current standards: ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42
Analysis of ionic compounds by CLI according to ISO 19227 and ISO 10993-18
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
Sectors of activity
Laboratory analysis of Medical Devices
Are you looking for a competent, specialized and ISO 17025 accredited laboratory for scopes specific to Medical Devices?
By combining analytical tools specific to medical devices with reliable and accurate scientific interpretations, FILAB assists manufacturers in marketing their medical devices.As the first French laboratory to be ISO 17025 accredited by COFRAC for cleaning residue analysis in accordance with the ISO 19227 set of standards and material characterization in accordance with ISO 10993-18, FILAB has the expertise and the complete analytical fleet needed to assist companies in the medical device industry.
Services dedicated to the analysis of medical devices:
FILAB most notably provides the following services :
Biocompatibility
ISO 10993-12: validation of extraction completeness
ISO 10993-18: Chemical characterisation of materials
ISO 10993-22 : Characterisation of nanomaterials
ISO 10993-14 : Identification and quantification of degradation products of ceramic-based medical devices
ISO 10993-13: Identification and quantification of degradation products from polymer-based medical devices
ISO 10993-19 : PMT characterisation (physico-chemical, morphological and topographical)
ISO 10993-7 : Determination of ethylene oxide and ethylene hydrochloride
ISO 10993-15: Study of degradation products in your medical devices
Analysis of cleaning residues
THC TOC analysis
Analysis and counting of particulate contaminants
Analysis of inorganic contaminants by ICP and CLI
Training in ISO 19227 regulations
The FILAB laboratory can provide you with support that goes beyond regulatory analysis, offering you personalised assistance to meet your specific needs... FILAB, a laboratory with expertise in analysis of medical device.
Les + FILAB
Une équipe hautement qualifiée
Une réactivité de réponse et de traitement des demandes
Un laboratoire accrédité COFRAC ISO 17025
(Portées disponibles sur www.cofrac.com - N° accréditation : 1-1793)
Un parc analytique complet de 2100m²
Un accompagnement sur-mesure
Our services
Particle counting laboratory according to EP 2.9.19
Chapter 2.9.19. of the European Pharmacopoeia relates to the control of non-visible particulate contamination. These new local requirements allow the test to be performed on volumes less than 5 mL. This analytical method is used to check the purity of a pharmaceutical injectable solution, or on the surface of medical devices and equipment. The FILAB laboratory, expert in particulate contamination counting according to method 2 of EP 2.9.19.
FILAB is COFRAC ISO 17025 accredited for particle counting analysis of medical devices and pharmaceutical solutions according to method 2 of EP 2.9.19
FILAB offers manufacturers specializing in the medical and pharmaceutical sectors technical skills and state-of-the-art analytical equipment in order to respond to their requests in the best possible way (possibility of carrying out these analysis in an emergency) and to provide them with the most appropriate services and tailor-made follow-up.
In order to respond accurately and reliably to these problems, FILAB offers tailor-made support for particle counts according to method 2 of EP 2.9.19, but also for other reference systems...
On pharmaceutical products:
The identification of foreign bodies and/or contaminants by SEM-EDX and Binocular Micro-Infrared, according to PE 2.9.52 and PE 2.2.54
Particle counting by Optical Microscopy and Image Analyzer, according to USP 788/789 and PE 2.9.19 (method 2)
On medical devices:
Particle Counting by Optical Microscope according to current standards: ISO 19227, ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
Particle identification by SEM-EDX and µ-IRTF according to the current standards: ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42
Our services
Particle Counting Laboratory for Medical Devices
European and international regulations such as USP 788, PE 2.9.19, AAMI TIR42, NF EN ISO 8536-9:2015... require the purity control of medical devices and among others the counting and identification of particulate contamination on the surface of materials.
Particulate contamination of medical devices
When a medical device is put on the market, it is necessary to verify that it does not contain impurities that could be released into the human body after its implantation. Indeed, particulate contamination presents risks for the quality of medical devices and for human health. Therefore, controlling the presence or absence of particulate contaminants and/or determining a level of particulate contamination is one of the key steps in a process. It is mandatory for the release of batches on the market, according to strict standards.
FILAB laboratory assists you in the analysis of particle counting on your Medical Devices according to the standards in force
FILAB laboratory is COFRAC ISO 17025 accredited for particle counting analysis on medical devices.
FILAB offers manufacturers of medical devices technical skills and state-of-the-art analytical equipment to respond to their needs in the best possible way and in a reactive manner.
In order to respond accurately and reliably to these problems, FILAB offers tailor-made support for the identification of particles on the surface of your medical devices, and to validate your cleaning processes. The laboratory is accredited ISO 17025 by COFRAC on the following scopes:
Particle Counting by Optical Microscope according to the current referentials: ISO 19227, ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
Particulate identification by SEM-EDX and µ-IRTF according to the current standards: ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42
More globally, FILAB assists medical device manufacturers with
Cleaning residue analysis according to ISO 19227
Biocompatibility testing according to ISO 10993: 10993-18, 10993-12, 10993-13, 10993-14, 10993-15, 10993-22
What is the procedure for particle contamination counting in medical devices according to AAMI TIR 42?
AAMI TIR 42 provides guidelines for performing particle contamination counting in medical devices. The recommended procedure includes the following steps: Sample Preparation: A representative sample of the medical device material is collected, taking care to avoid contamination during the collection process. Test Method Selection: The appropriate test method is selected based on the properties of the material and the type of particles to be analyzed. Optical microscopy is the recommended method for particle counting according to AAMI TIR 42. Optical Microscopy Analysis: The sample is examined under an optical microscope, using a magnification and illumination that are appropriate for the size and type of particles to be analyzed. The microscope should be calibrated prior to analysis to ensure accurate measurements. Particle Counting: The number of particles in the sample is counted and recorded, along with their size range and characteristics such as shape and composition. Data Analysis: The particle count data is analyzed to determine the degree of particle contamination present in the material. The results are compared to established acceptance criteria to determine if the material meets the required standards for safety and efficacy. Reporting: The results of the particle contamination counting analysis are reported, including the testing methods used, the number and characteristics of particles found, and any conclusions or recommendations based on the results. It is important to perform particle contamination counting according to the guidelines in AAMI TIR 42 to ensure accurate and reliable results and to comply with regulatory requirements. By following this procedure, medical device manufacturers can identify and quantify any particle contamination present in their materials and take appropriate action to ensure the safety and efficacy of their products.
What are the risks if your particle contamination counting is not compliant with the AAMI TIR 42 norm?
In Europe, medical device manufacturers are required to comply with the Medical Device Regulation (MDR) 2017/745, which sets out the legal requirements for the design, manufacture, and marketing of medical devices. Compliance with AAMI TIR42 can be considered a best practice for meeting the safety and performance requirements outlined in MDR. If particle contamination counting for medical device materials is not compliant with AAMI TIR 42 or other applicable standards, there may be legal risks for the manufacturer. Non-compliance with these standards can result in unsafe and ineffective products, which can lead to serious consequences for patient health. Under MDR, medical device manufacturers are responsible for ensuring that their products are safe and effective for their intended use and comply with all applicable regulatory requirements. Failure to comply can result in regulatory action, such as product recalls, fines, restrictions on market access, or withdrawal of CE marking. In addition to regulatory risks, non-compliance with AAMI TIR 42 or other standards can also result in legal liability for the manufacturer. If a patient is harmed by a medical device that contains particle contamination due to non-compliance with these standards, the manufacturer may be held liable for damages, including medical expenses, lost wages, and pain and suffering.
Sectors of activity
Surface analysis dedicated to Medical Devices
Why study the surface properties of your medical devices?
First of all, what is the surface of a medical device? It is an area composed of different specific characteristics. These can impact the overall performance of the medical device and potentially its reliability and robustness in case of failure.
In addition, the surface properties of medical devices also condition their qualities and biocompatibility. They are thus the subject of interrogations at the time of the creation of the medical device until its biological evaluation.
Moreover, the knowledge of the properties and surface states of a material can allow you to adapt your manufacturing processes. Thus, it is possible to implement specific surface treatment or cleaning processes.
FILAB supports you in the surface analysis of medical devices
In this context, advanced physico-chemical techniques make it possible to obtain precise data on the surface analysis of medical devices, including the nature and composition of the extreme surface:
Morphological study of the surface of a material (porosity, roughness,...)
Study of surface extractables and leachables according to ISO 10993-18
PMT study according to ISO 10993-19
Study of degradation products according to ISO 10993-9/-13/-14/-15
Measurement of the thickness of surface layers
Process validation: Cleaning (ISO 19227), surface treatment
Identification of surface pollution (analysis of particles, deposits, etc.)
Cleaning process validation
The standards that accompany the surface analysis of medical devices...
The international standard ISO 19227, entitled "Surgical Implants - Cleanliness of Orthopaedic Implants - General Requirements", describes the requirements for the cleanliness of orthopaedic implants and the validation of the cleaning processes used.
ISO 10993-19 provides a set of parameters and analytical methods associated with the physical, morphological and topographical (PMT) characterization of DM. Indeed, these parameters play an important role in the evaluation of biocompatibility but also in the screening of new materials. The surface properties studied are: morphology, crystallinity, surface chemistry, porosity, bio interactions. They are obtained by SEM, XPS or ToF-SIMS.
The ISO 10993-18:2020 standard - "Chemical characterization of medical device materials" - studies the soluble and non-soluble extractables present on the surface of the device. For soluble extractables, they are identified after extraction, filtration and analysis by SEM and Infrared Microscopy.
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
Our services
Analysis according to NF S94-091 in laboratory
Manufacturers of Medical Devices, you want to analyze your products according to the NF S94-091 standard
What is the NF S94-091 standard?
First of all, the NF S94-091 standard is the former title of the standard now known as ISO 19227. Thus, it is a document that defines the validation requirements for the cleaning process of orthopedic implants before final packaging. In fact, it specifies the test methods to be used for the validation of the cleaning process and the controls. The objective of this standard is to guarantee the physico-chemical and microbiological cleanliness of orthopaedic implants. These can be :joint prosthesesspinal implantsosteosynthesis material, etc...Moreover, orthopaedic implants can be coated or uncoated metallic implants, ceramic, polymer, multi-material, composite implants, intended to be sterilized.
Pourquoi analyser vos dispositifs médicaux selon la norme NF S94-091 ?
The analysis of your medical devices, especially orthopedic prostheses, according to the NF S94-091 standard allows you to check the conformity of your finished products.Indeed, medical devices are particularly controlled because of their contact with the patient's body.Thus, the support of a laboratory specialized in the analysis of orthopedic implants for the verification of the conformity of your products is an essential asset for their marketing.
FILAB supports you in the analysis of your medical devices according to the NF S94-091 standard
As an expert in the field of analysis for the medical sector, the FILAB laboratory accompanies you at each stage of the analysis of your Orthopaedic Implants according to the NF S94-091 standard, using validated and documented methods.Our experts are at your disposal and offer you their analysis services in accordance with the NF S94-091 standard.
To go further
ISO 10993-12: validation of extraction completeness
ISO 10993-13 and ISO 10993-14: Identification and quantification of degradation products of polymeric and ceramic medical devices
ISO 10993-22: Characterization of nanomaterials
ISO 10993-18: Chemical characterization of materials
ISO 10993-7 : Determination of ethylene oxide and ethylene hydrochloride
ISO 10993-19: PMT characterization (physicochemical, morphological and topographical)
Demander un devis
Les + FILAB
Une équipe hautement qualifiée
Une réactivité de réponse et de traitement des demandes
Un laboratoire accrédité COFRAC ISO 17025
(Portées disponibles sur www.cofrac.com - N° accréditation : 1-1793)
Un parc analytique complet de 2100m²
Un accompagnement sur-mesure
