Ophthalmic implants require sensitive analytical methods and specific expertise in medical devices. A specialized laboratory has the appropriate equipment, validated protocols, and the ability to interpret results in light of regulatory requirements. This enables manufacturers to compile robust dossiers and secure the market launch of their implants.
More than 140 people
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5200 m² laboratory
+ 99% of services are provided in-house
Accredited laboratory
COFRAC ISO 17025
Would you like to perform a biocompatibility analysis of your ophthalmic implants and intraocular lenses according to ISO 11979-5?
Specialized in the analysis and characterization of materials, the FILAB laboratory supports medical device manufacturers in assessing the safety and compliance of their products. Our teams work in particular on intraocular lenses and ophthalmic implants to identify extractable and leachable substances, characterize materials, and document regulatory files.
FILAB, an expert in biocompatibility testing for intraocular lenses and ophthalmic implants
The ISO 11979-5 standard governs the assessment of the biocompatibility of intraocular lenses (IOLs) by requiring comprehensive characterization of materials and substances that may be released into the body.
As a specialized testing laboratory, FILAB supports medical device manufacturers in bringing their products into compliance through highly precise analytical services.
Biocompatibility testing according to ISO 11979-5
The ISO 11979-5 standard is based on a risk-based approach combining:
- thorough physicochemical analysis
- a toxicological assessment of substances
- targeted biological testing
FILAB provides analytical support for all these requirements, particularly chemical characterization, a key step in the process.
Our analytical services for ISO 11979-5
Services: ISO 11979-5
Identification of extractable substances
As part of the identification of extractable substances, we conduct exhaustive extraction studies to identify:
- residual monomers
- additives
- contaminants originating from the manufacturing process
Analysis of leachable substances
Our teams assess compounds that may be released under simulated physiological conditions:
- quantification of leachables
- comprehensive chemical profiles
- assessment of the associated risk
Material stability studies
FILAB conducts stability studies to verify material performance over time:
- hydrolytic stability
- UV-visible photostability
- impact of medical treatments (Nd laser)
Contaminant and impurity screening
Through contaminant and impurity screening, we detect and quantify insoluble inorganic components and other trace substances at very low levels.
Our analytical capabilities for testing according to ISO 11979-5
GC-MS
identify volatile and semi-volatile organic compounds that may be present in the materials or released by the implant
LC-MS
identify non-volatile organic compounds
ICP-MS / ICP-OES
analysis of inorganic elements
SEM-EDX
inspection of surfaces and edges, and detection of microcracks or particle deposits
The FILAB laboratory supports you with the biocompatibility analysis of your ophthalmic implants and intraocular lenses according to ISO 11979-5
A laboratory dedicated to your biocompatibility assessment
Intraocular lenses and ophthalmic implants are subject to strict requirements in Europe and internationally. analysis must be reliable, traceable, and compliant with medical industry standards.
Beyond analysis, FILAB supports you with:
interpreting results according to ISO 10993
requirementsscientific justification of data for your regulatory dossiers
toxicological risk assessment (TTC, acceptable thresholds)
investigations in the event of non-compliance
Why choose FILAB for the biocompatibility analysis of your ophthalmic implants and intraocular lenses according to ISO 11979-5?
- Expertise in trace analysis and complex chemical characterization
- Mastery of the requirements of ISO 11979-5 and ISO 10993
- Tailored support for your CE / MDR dossiers
- Responsiveness and adaptability for R&D and industrial projects
Our FAQ
Why perform analysis of intraocular lenses and ophthalmic implants according to ISO 11979-5:2020?
analysis 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 help better control the risks associated with the materials used and their manufacturing process. These analytical investigations are essential for meeting international regulatory requirements, securing market approval dossiers, and ensuring a high level of patient safety.
Why analyze intraocular lenses and ophthalmic implants?
Ophthalmic implants are in direct and prolonged contact with ocular tissues. analysis therefore verify that the materials do not release substances that could pose a risk to the patient. They also document the device’s safety and help meet the regulatory requirements applicable to implantable medical devices.
What is an extractables and leachables study?
An extractables and leachables study identifies the chemical compounds that may be released by 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 analysis be performed?
analysis may be performed at various stages of a device’s life cycle:
product development phase
material qualification
regulatory validation
quality control
investigation of non-compliance or a defect
They provide reliable analytical data to support secure industrial decision-making.
Why work with a specialized laboratory such as FILAB?
How can you obtain a quotation from FILAB?
To obtain a quotation, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (material type, requested analysis, applicable standard, urgency, number 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 type of 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 requirements.
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