Achieve regulatory compliance and global acceptance
Achieve regulatory compliance and global acceptance
In the medical field, practitioners utilize a range of devices to address patient health, from diagnosis to surgery. When the patient comes into contact with a medical device or material, it should fulfill its intended function without harming the patient. Therefore, all medical devices need to undergo a thorough biological risk assessment to protect the patient from any toxic, physiological, immunogenic or mutagenic effects from the device. This can be achieved with biocompatibility testing.
As an integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system. It studies the interaction between the device and the various types of living tissues and cells exposed to the device when it comes into contact with patients.
The goal for all medical device manufacturers is to provide maximized benefits to patients while minimizing levels of biological risks. This requires them to comply with stringent biocompatibility testing requirements set by international regulatory bodies to ensure that their devices are medically safe to use before being made available in the market.
Discover the specifics of the chemical characterization process, the importance in the overall evaluation of medical device safety, and more.
TÜV SÜD provides a comprehensive range of medical device testing solutions required by relevant regulatory frameworks worldwide. We offer a complete biocompatibility testing panel for medical devices through our state-of-the-art laboratories and high standards of data and quality reporting to address the testing needs of small and large-scale manufacturers.
Our team of medical doctors, engineers and toxicologists possess the technical, clinical and regulatory expertise required to thoroughly evaluate biocompatibility test results of medical devices for suitability across global markets. We provide end-to-end assistance with efficient use of resources, while ensuring that project timelines are met with predictability and diligence.
TÜV SÜD is globally recognized and trusted for its quality and safety as a third-party one-stop testing provider. We offer a suite of testing services required for medical devices and help manufacturers and suppliers meet global regulatory standards independently.
TÜV SÜD provides the following biological risk assessment tests to help manufacturers meet biocompatibility testing requirements of the International Organization for Standardization (ISO), U.S. Food and Drug Administration (FDA) and American Society for Testing and Materials (ASTM).
Biocompatibility testing is part of an overall risk management process to protect humans from potential biological risks stemming from the use of medical devices.
The evaluation of biocompatibility testing data for a particular device is used as evidence in establishing the device's biological safety.
Device biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application [definition per ISO 10993:2018]. More specifically, it is the ability of a medical devices’ materials to perform its intended function, without producing any undesirable effects in the patient, in terms of tissue response given the specific situation.
The ISO 10993 series are a set of standards for evaluating the biocompatibility of medical devices.
The first part of the series, ISO 10993-1, is the umbrella standard that gives an overview of what a biological risk evaluation should entail, from risk management to existing data and information about the device and its materials to chemical characterization and biological endpoint testing.
The laboratory performs in vitro test methods such as cytotoxicity tests. We partner with dedicated subcontracted laboratories to perform in vivo sensitization, irritation tests, and other biological endpoint tests.
We are in the process of validating irritation and sensitization tests in vitro to be performed in our lab.
Chemical characterization is the process of obtaining qualitative and quantitative chemical information, carried out by collecting information about the constituent materials, chemicals, or substances of a medical device.
The chemical characterization process uses several technologies and evaluation methods, such as microscopic and spectroscopic analysis, x-ray diffraction, and chromatography.
These techniques provide detailed information about identifying the chemical formulation of a material. Chemical characterization combined with toxicological data can also provide critical information about the nature and extent of potential health, safety, or environmental risks that may occur using such materials throughout the device's life cycle.
The definition of "extractable" from the ISO 10993-18:2020 is a "substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles." Extraction conditions are often exaggerated compared to the clinical use, e.g., higher temperatures, longer extraction times, etc.
The definition of "leachable" from the same standard is a "substance that is released from a medical device or material during clinical use." Often leachable studies are performed using conditions that simulate clinical use, e.g., clinical use temperatures and extraction times, etc.
The ISO 10993-1:2018 standard requires a structured biological evaluation plan within a risk management process. TÜV SÜD can assist with the biological evaluation plan generation, toxicological risk assessment, and the conclusive biological evaluation report to help your device meet the risk requirements of the standard.
When you are ready to send a sample, TÜV SÜD will send you a sample submission form to collect information about the device to be tested. After that, we will send the shipping addresses to receive your samples. The samples will be registered and stored under controlled conditions until they are ready to be tested in our laboratory.
Our TÜV SÜD laboratories are fully ISO 17025 accredited. Our US labs are also able to perform testing under Good Laboratory Practices (GLP).
TÜV SÜD offers testing services in bioburden, bacterial endotoxin, reprocessing studies for reusable medical devices, microbial recovery validation studies, biological indicator sterility testing, sterilization validations, etc.
Learn about the biocompatibility, microbiology, and sterility tests that our experts can perform
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Discover the specifics of the chemical characterization process, the importance in the overall evaluation of safety.
Understand the importance of a biological evaluation