At UL Solutions, we have state-of-the-art laboratories around the world with strong teams of professionals in diversified domains providing both lab and engineering services for your testing needs for North American market access.
Biocompatibility and chemical characterization
Biocompatibility testing is an important component of the biological risk assessment and overall safety evaluation for medical devices, consumer products and raw materials.
UL Solutions can perform the following tests:
- Biocompatibility — cytotoxicity, sensitization and irritation
- Chemical characterization — extractable and leachable testing is performed to determine the chemical compounds within a product that could possess toxic traits. Examples include:
- Material characterization of medical devices
- Residual analysis
- Toxicological risk assessment
Biological risk assessment of medical devices, consumer products and raw materials requires the characterization of toxicological hazards and exposures, as well as other potential biological responses to devices. Chemical characterization plays a key role in the identification of hazards. In our chemical characterization services, we perform extractable and leachable testing to determine the chemical compounds within your product that could possess toxic traits. Chemical characterization can include the material characterization of medical devices; physicochemical analyses of devices’ polymeric materials, metals and ceramics; residual analyses; and toxicological risk assessment.
The characterization information we generate can be used as part of an assessment of the device’s overall biological safety and the toxicological risk assessment in accordance with ISO 10993-17. We can also use chemical characterization and toxicological risk assessment to determine whether further biological testing is needed.
UL Solutions evaluates biocompatibility and chemical characterization to standards including (but not limited to):
- ISO 10993-5, Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices — Tests for Skin Sensitization
- ISO 10993-18, Biological Evaluation of Medical Devices, Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 10993-23, Biological Evaluation of Medical Devices, Part 23: Tests for Irritation
- ISO 18562, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
Microbial ingress testing
Microbial ingress testing is the evaluation of the medical device’s ability to resist or inhibit the transfer of infectious microorganisms under repeated simulated use conditions, can be used to help manufacturers mitigate the risk of patient infection through the product design and effective disinfection practices.
Microbial ingress testing is not referenced in any standard. UL Solutions experts perform microbial ingress testing by following the procedure created by the device manufacturer for the testing provider to follow.
Cleaning validation
Manufacturers of medical devices, consumer products and raw materials intended for reuse must provide detailed reprocessing instructions and prove that these procedures are valid. They must also demonstrate the safety of the product after reprocessing and over the entire product lifecycle.
Using validated tests methods, we can support your validation studies and work with you on a combination of different tests, as needed. Our team offers evaluations to standards including (but not limited to):
- ASTM E2314, Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
- ISO 11737-1, Sterilization of Health Care Products — Microbiological Methods — Part 1: Determination of a Population of Microorganisms on Products
- ISO 11737-2, Sterilization of Health Care Products — Microbiological Methods — Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
- ISO 17664, Sterilization of Medical Devices — Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
Why choose UL Solutions
UL Solutions’ microbiological and analytical laboratories in Research Triangle Park, North Carolina, are accredited to ISO/IEC 17025 by IAS and Good Laboratory Practice (GLP). We use science-based methodologies to evaluate products for consistency and compliance with global standards and regulations. Our global network of highly equipped laboratories and experienced professionals in diverse domains of expertise offer comprehensive laboratory and engineering services.
Related standards
Through our extensive network of testing laboratories, UL Solutions can evaluate medical and medical devices to the following standards:
Biocompatibility and chemical characterization
- ISO 18562, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
- ISO 10993-5, Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices — Tests for Skin Sensitization
- ISO 10993-17, Biological Evaluation of Medical Devices, Part 17: Toxicological Risk Assessment of Medical Device Constituents
- ISO 10993-18, Biological Evaluation of Medical Devices, Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process
- ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing Within a Risk Management Process
- ISO 10993-12, Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials
- ISO 10993-23, Biological Evaluation of Medical Devices, Part 23: Tests for Irritation
Cleaning validation
- AAMI TIR12, Designing, Testing, and Labeling Medical Devices Intended for Processing by Health Care Facilities: A Guide for Device Manufacturers
- AAMI ST98, Cleaning Validation of Health Care Products — Requirements for Development and Validation of a Cleaning Process for Medical Devices (formerly AAMI TIR30)
- ISO 17664, Processing of Health Care Products — Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices, Part 1: Critical and Semi-critical Medical Devices
- ASTM E2314, Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
- ASTM E1053, Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
- ASTM E2274, Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants
- ASTM E2314, Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
- ASTM E2315, Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure
- ASTM E1837, Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
- ASTM C1338, Standard Test Method for Determining Fungi Resistance of Insulation Materials and Facings
- ASTM G21, Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi
- ISO 11737-1, Sterilization of Health Care Products — Microbiological Methods — Part 1: Determination of a Population of Microorganisms on Products
- ISO 11737-2 – Sterilization of Health Care Products — Microbiological Methods — Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
- ISO 22196, Measurement of Antibacterial Activity on Plastics and Other Non-porous Surfaces Cleaning Validation
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