Medical Devices
Renolab performs in vitro biocompatibility testing for medical devices according to ISO 10993 standards, including cytotoxicity, irritation, sensitization and genotoxicity studies.
Renolab performs a range of in vitro tests used for the biological evaluation of medical devices, aimed at assessing the potential biological risks associated with substances that may be released during use.
All tests are conducted in accordance with internationally recognised standards and methodologies specific to each type of biological endpoint.
Sample Preparation and Extraction
Sample preparation and extraction of medical devices are carried out according to ISO 10993-12.
These procedures allow the preparation of extracts that represent the substances potentially released from the device under defined testing conditions. The extracts obtained are then used in subsequent biological tests to evaluate possible effects on cells or tissues.
Microbiological Testing
Renolab performs bioburden testing to determine the level of bacterial contamination present on medical devices.
This analysis, carried out according to ISO 11737-1, allows the quantification of viable microorganisms that may be present on the device prior to sterilization or further processing.
Cytotoxicity Testing
Cytotoxicity testing evaluates the potential toxic effects of substances released from a medical device on cultured cells.
The study is performed using the XTT test, according to ISO 10993-5, which measures cell viability after exposure to device extracts. The test provides information on possible cellular damage or reduction in cell metabolic activity.
Skin Irritation and Sensitization Testing
Skin Irritation Testing
In vitro skin irritation testing evaluates whether substances associated with a medical device may cause irritation when in contact with the skin.
These studies are performed using validated in vitro methods according to ISO 10993-23 and OECD Test Guideline 439, which allow the assessment of potential irritation using reconstructed skin models.
Skin Sensitization Testing
Skin sensitization testing evaluates the potential of substances associated with a medical device to induce allergic reactions after skin exposure.
These evaluations are performed using in vitro sensitization methods in accordance with ISO 10993-10 and OECD Test Guidelines 442C, 442D and 442E, which are used to investigate key biological mechanisms involved in skin sensitization.
Eye Irritation Testing
Eye irritation testing evaluates the potential ocular effects of substances released from medical devices.
The assessment is conducted using in vitro methodologies, including the reconstructed human cornea-like epithelium test, performed according to OECD Test Guideline 492B.
Genotoxicity Testing
Genotoxicity testing is performed to evaluate the potential of substances associated with a medical device to cause genetic damage. These studies assess whether compounds released from the device may induce mutations or alterations in the genetic material of cells.
Testing is carried out using in vitro methods, in accordance with ISO 10993-3 and OECD Test Guideline 471.
Regulatory Framework
Medical devices placed on the European market are regulated under:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical device
FAQ
What is biocompatibility testing for medical devices?
Biocompatibility testing evaluates the potential biological risks associated with a medical device when it comes into contact with the human body. These tests assess effects such as cytotoxicity, irritation, sensitization and genotoxicity.
Which ISO standards are used for medical device biocompatibility testing?
Biocompatibility testing is commonly performed according to the ISO 10993 series of standards, which define methods for the biological evaluation of medical devices.
What is cytotoxicity testing for medical devices?
Cytotoxicity testing evaluates whether substances released from a medical device can damage or reduce the viability of cultured cells. The test can be performed according to ISO 10993-5.
What is bioburden testing for medical devices?
Bioburden testing determines the level of microbial contamination present on a medical device prior to sterilization or use.
What is skin sensitization testing for medical devices?
Skin sensitization testing evaluates the potential of substances released from a device to cause allergic reactions. These tests can be performed using in vitro methods described in OECD guidelines.
Which regulation governs medical devices in the European Union?
Medical devices in the European Union are regulated by Regulation (EU) 2017/745 (MDR), which defines safety, performance and conformity assessment requirements for devices placed on the EU market.