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BIOCOMPATIBILITY – WHY, WHEN, and HOW?

The concept of biocompatibility refers to the interaction between the tissues and the physiological systems of a patient treated with a medical device. The biocompatibility assessment is part of the overall device safety assessment.

Medical device biocompatibility assessment is actually carried out in order to ensure patient safety. When programming a biocompatibility test, manufacturers need to consider their compliance objectives and risks. In fact, medical device biocompatibility evaluation is a risk assessment study. All medical devices have a certain level of risk. Firms that design medical devices strive to maximize the benefits they provide to patients by minimizing risk.

The main standard in biocompatibility testing is the ISO 10993 standards. The first part of this standard is the test selection guide. The following sections cover specific test processes and other test related considerations.

Biocompatibility testing data is always required for devices with significant tissue contact. The ISO 10993-1 material biocompatibility matrix is used to determine whether a medical device requires a biocompatibility test. ISO 10993-1: 2018 through the Biological Evaluation Plan (BEP) allows to determine the potential risk based on the data provided by the Sponsor (information on raw materials, packaging, production conditions and previously performed studies). The next step is a series of studies proposed in the BEP to verify risk assessments, and finally in the Biological Evaluation Report (BER) risk assessment is summarized and explained what the potential sources of non-compliance could be.

In every region of the world, medical device manufacturers are required to prove the biocompatibility performance of their products. In some countries (China, USA, Canada), biocompatibility testing requirements may differ. If the manufacturer stores data from previous shipments, data from material or component suppliers, analytical data and clinical data, the number of tests is slightly reduced.

The main purpose of the ISO standard is to verify that the device is suitable for the intended use. In this process, biological testing is the most important step in a biocompatibility assessment. The standard classifies devices by type of body contact and duration.

Biocompatibility is often associated with the necessity to perform a complete set of tests for new medical devices that are yet to be released on the market. But manufacturers of medical devices must remember that sometimes a seemingly small change in the production process of products already available on the market (for example: changing one of the materials, changing the production method, introducing new machines into the production line, or an apparently insignificant change in the sterilization method) is associated with another risk assessment and performing biocompatibility tests. Also manufacturers are required to collect safety data for all components and materials used in medical devices.

Konmex BioLabs is Good Laboratory Practice (GLP) certified and ISO 17025 accredited. Our company also provides biocompatibility testing services in the field of certification services. Thanks to these services, enterprises are able to produce more efficient, high-performance and high-quality products in a safe, fast and uninterrupted manner.

For further information, please contact your sales representative team if you’re an existing customer or if you’re new to Konmex BioLabs please reach us at biolabs@konmex.com or visit our website https://biolabs.konmex.com/

We look forward to helping you reach all of your evaluation goals and a successful submission!

We are here to support you!

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation.

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation.
The long-awaited ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation has been finally published!
 
Irritation tests of medical devices were taken out from ISO 10993-10, and now are fully described in dedicated ISO 10993-23 – many changes have been introduced…
 
This documents describes a stepwise approach for irritation testing of medical device. Furthermore, a new in vitro alternative test using Reconstituted human Epidermis was described.
 
Are you looking for gap analysis of your irritation tests? Or maybe you need your device to be complied with the latest ISO 10993-23?
 
Just contact us – we are ready to test medical devices in accordance to the latest ISO 10993-23!

One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3 and 10993-33.

One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3 and 10993-33.

We conduct genotoxicity with both prokaryotic (bacterial strains – AMES method) and eukaryotic test systems (mammalian cell lines – Mouse Lymphoma Assay).

Genotoxicity testing applies to various kinds of medical devices, ranging from surface medical devices (e.g. coming into contact with mucosal membrane) to implants (and many other on the way). With these tests, we can evaluate if your product is prone to causing DNA damage in your patients’ cells.

These tests are considered the most time and work-consuming among the in vitro tests, yet our experienced team can handle your product with care and precision – you can be sure, that your results will be dependable and reliable.

You are not sure whether your products needs genotoxicity testing❓

Contact us to obtain more specific information, as well as consulting services. If your product is considered “unusual” – let us know, we can tailor the tests specifically for your needs. And guess what – GLP standard is also available.

PYROGENICITY is the ability of a chemical agent or other substance to produce a febrile response

PYROGENICITY is the ability of a chemical agent or other substance to produce a febrile response.
Pyrogenic responses may be material-mediated, endotoxin-mediated, or mediated by other substances.
In accordance with the ISO 10993-11 we commonly conduct two test types:
LAL (Limus Amebocyte Lisate) test to detected endotoxin-specific factors,
Material-mediated pyrogenicity test (Rabbit Pyrogen Test) which has a wide range for detecting non-endotoxin pyrogenicity for example endogenous pyrogens, prostaglandins, bacterial exotoxins, neurotransmitters and metals such as nickel salt, in same instances.
Are you confused what kind of test you need.
Contact us to choose the right method for your device!

The sensitization test is the second, except for the irritation test, in vivo biological endpoint to be evaluated any type of medical device required by ISO 10993-1: 2018.

The sensitization test is the second, except for the irritation test, in vivo biological endpoint to be evaluated any type of medical device required by ISO 10993-1: 2018.
In ISO 10993-10 three types of sensitization tests are mentioned: Guinea pig maximization test (GPMT), Buehler test, and Local lymph node assay (LLNA). The appropriate method should be chosen taking into account the application, properties, and intended region of registration of the medical device.
We carry out all of the mentioned methods for testing sensitization. Contact us to choose the right method for your device!

Irritation or Intracutaneous reactivity is one of two in vivo biological endpoints to be evaluated of a medical device according to the ISO 10993-1:2018.

Did you know that Irritation or Intracutaneous reactivity is one of two in vivo biological endpoints to be evaluated of a medical device according to the ISO 10993-1:2018.
In accordance with the ISO 10993-10, we conduct Irritation and Intracutaneous reactivity tests. We are also able to conduct many other types of irritation tests, such as: skin irritation, eye irritation, irritation of the mucosa and etc.
You do not know what kind of test should be used for your device?
Contact us to choose the right method.

Our Customer successfully registered his product in CFDA (Chinese Food and Drug Administration) based on Konmex BioLabs reports and support!

We are proud to inform, that our Customer successfully registered his product in CFDA (Chinese Food and Drug Administration) based on Konmex BioLabs reports and support!
The chemical characterization (ISO 10993-18) and toxicological evaluation (ISO 10993-17) were crucial in this process. We did also other ISO 10993 biocompatibility tests according to the: ISO 10993-3, ISO 10993-5, ISO 10993-6. ISO 10993-10, ISO 10993-11, that were used for the product registration.
If you are looking for any ISO 10993 biocompatibility testing, just let us know.

We perform cytotoxicity tests of medical devices by ISO 10993-5

Do you know that we perform cytotoxicity tests of medical devices by ISO 10993-5 every day, which are used to register products in many markets?

The basis for the success of this study is the selection of the appropriate methodology because medical devices are fundamentally different from each other: intended use, composition, operation etc.

If your company needs a product test comparison – we invite you to cooperate!