Ophthalmic implants require sensitive analytical methods and specific expertise in medical devices. A specialized laboratory has the appropriate equipment, validated protocols, and the capacity to interpret results in accordance with regulatory requirements. This allows manufacturers to compile robust dossiers and ensure the safe market entry of their implants.
More than 140 people
at your service
5200 m² laboratory
+ 99% of services are provided in-house
Accredited laboratory
COFRAC ISO 17025
You would like to carry out a biocompatibility analysis of your ophthalmic implants and intraocular lenses according to the ISO 11979-5 standard
Specializing in materials characterization and analysis , the FILAB laboratory assists medical device manufacturers in assessing the safety and compliance of their products. The teams work particularly on intraocular lenses and ophthalmic implants to identify extractable and leachable substances, characterize materials, and document regulatory dossiers.
FILAB, experts in analyses for the biocompatibility of intraocular lenses and ophthalmic implants
As a specialized analytical laboratory, FILAB supports medical device manufacturers in ensuring their products comply with ISO standards through high-precision analytical services.
Biocompatibility analysis according to ISO 11979-5
The ISO 11979-5 standard is based on a risk-based approach, combining:
- comprehensive physicochemical analysis
- toxicological evaluation of substances
- targeted biological testing
FILAB provides analytical support for all these requirements, particularly for chemical characterization, a key step in the process.
Our analytical services for the ISO 11979-5 standard
Services: ISO 11979-5
Identification of extractable substances
As part of the process of identifying extractable substances, we conduct comprehensive extraction studies to identify:
- residual monomers
- additives
- contaminants from the manufacturing process
Analysis of leachable substances
Our teams assess the compounds likely to be released under simulated physiological conditions:
- quantification of releases
complete - chemical profiles
- assessment of associated risk
Material stability studies
FILAB conducts stability studies to verify the long-term performance of materials:
- hydrolytic stability
- UV-visible photostability
- impact of medical treatments (Nd laser)
Search for contaminants and impurities
Through the search for contaminants and impurities we detect and quantify insoluble inorganic components and other traces at very low levels.
The FILAB laboratory assists you in the biocompatibility analysis of your ophthalmic implants and intraocular lenses according to the ISO 11979-5 standard
A laboratory at your service for your biocompatibility assessment
Intraocular lenses and ophthalmic implants are subject to strict requirements in Europe and internationally. Analyses must be reliable, traceable, and compliant with medical industry standards.
Beyond analysis, FILAB supports you in:
Interpretation of results according to ISO 10993 requirements
the scientific justification of the data in your regulatory files
toxicological risk assessment (TTC, permissible thresholds)
investigations in case of non-compliance
Why choose FILAB for biocompatibility analysis of your ophthalmic implants and intraocular lenses according to ISO 11979-5?
- Expertise in trace analysis and complex chemical characterization
- Mastery of ISO 11979-5 and ISO 10993 requirements
- Tailored support for your CE/MDR applications
- Responsiveness and adaptability to R&D and industrial projects
Our FAQ
Why perform analysis of intraocular lenses and ophthalmic implants according to ISO 11979-5:2020?
Analyses performed on intraocular lenses and ophthalmic implants identify potentially toxic substances that may be present in the materials or released by the device. They also contribute to better managing the risks associated with the materials used and their manufacturing process. These analytical investigations are essential to meet international regulatory requirements, ensure the security of market authorization dossiers, and guarantee a high level of safety for patients.
Why analyze intraocular lenses and ophthalmic implants?
Ophthalmic implants are in direct and prolonged contact with ocular tissues. Therefore, analyses are used to verify that the materials do not release substances that could pose a risk to the patient. They also serve to document the device's safety and to meet the regulatory requirements applicable to implantable medical devices.
What is an extractables and releaseables study?
An extractables and leachables study involves identifying the chemical compounds that could be released from an implant. Specific solvents and conditions are used to simulate or amplify migration phenomena. The detected substances are then identified and quantified to assess their potential toxicological impact.
When should these analyses be carried out?
Analysis can be performed at various stages of a device's lifecycle:
- Product development phase
- Materials qualification
- Regulatory validation
- Quality control
- Investigation of non-conformities or defects
They provide reliable analytical data to support informed industrial decisions.
Why use a specialist laboratory like FILAB?
How to get a quote from FILAB?
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
What is the typical duration of the analysis?
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
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 facility of 5,200m²
Tailor-made support
Video debriefing available with the expert
Ask for your quote