Biological safety testing (ISO 10993-1, FDA, USP)
Able to respond to pharmaceutical applications in various countries.
In the field of medical devices, ensuring biological safety with consideration of risk assessment is required, as stipulated in ISO 10993-1. It is necessary to evaluate potential risks, such as toxicity and allergic reactions, to human tissues that come into direct or indirect contact with the medical device. There are various tests, including cytotoxicity tests, irritation tests, sensitization tests, genotoxicity tests, implantation tests, and blood compatibility tests. However, the selection of necessary tests/evaluation items for regulatory compliance must be conducted with consideration of the characteristics of each medical device. ISO 10993-1 categorizes medical devices based on the areas of contact with the human body and the duration of contact, providing endpoints according to the characteristics of the medical device (Table A). However, differences exist among regulatory authorities regarding the recommended testing methods and sample extraction procedures, so it is essential to thoroughly understand these differences. Our company is capable of conducting tests that comply not only with ISO 10993 but also with a wide range of regulations and standards, including FDA guidance, guidelines from the Ministry of Health, Labour and Welfare, USP, and OECD. We also provide toxicological risk assessments in addition to testing.
basic information
In biological safety testing, regulatory authorities in each country require certification of ISO/IEC 17025 and test results conducted under GLP (Good Laboratory Practice) conditions at the time of application. UL Solutions' testing laboratory is accredited by IAS (International Accreditations Service, Inc.) of the United States, a member organization of ILAC (International Laboratory Accreditation Cooperation) MRA (Mutual Recognition Arrangement), and is valid when regulatory authorities in various countries demand accredited and GLP-compliant testing and evaluation.
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[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 3: Reprocessing Validation of Medical Devices (ISO 17664)
In diagnosis and treatment, many medical devices come into contact with the human body of patients. This can include contact with healthy skin, as well as contact with wounds or circulating blood and tissues. Naturally, these devices must undergo processes such as cleaning, disinfection, and sterilization to ensure they are in a condition suitable for contact with the human body. Reprocessing of medical devices, including cleaning, disinfection, and sterilization, is often carried out by healthcare institutions. To ensure proper reprocessing, medical device manufacturers are required to provide information regarding reprocessing through user manuals and accompanying documents. In this webinar, we will introduce the items that medical device manufacturers should provide to healthcare institutions regarding the reprocessing process as required by international standards, as well as the specific reprocessing requirements for cleaning, disinfection, and sterilization. We will also discuss lifecycle testing to ensure that reusable medical devices are always safe. Content: 1. ISO 17664 and the reprocessing of medical devices 2. Cleaning 3. Disinfection 4. Sterilization 5. Lifecycle testing
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[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 1: Medical Device Regulations and Safety Standards
We will be holding our popular webinar series on the introduction to safety standards for medical devices again this year, enhancing the content as always. In its third year, this time we will add new themes and incorporate the latest information, providing clear explanations of the overview of standards related to medical devices, as well as safety testing and evaluation points. We encourage you to use this as internal training for those involved in development, regulatory affairs, and quality control at medical device manufacturers. This webinar serves as an introduction to the "Webinar Series on Understanding Safety Standards for Medical Devices from the Basics," where we will introduce the regulations and standards for testing and evaluation related to safety for medical devices in major countries. We will also delve into the standards concerning usability and cybersecurity that will be applicable in Japan in 2024. We hope this will help you understand and prepare the necessary items for testing and evaluation in advance, thereby reducing the burden of applications as much as possible.
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[Medical Device Safety Standards Introductory Seminar 2024] Session 4: Biological Evaluation (ISO 10993-1)
In order to advance the evaluation of biocompatibility required as non-clinical trials in drug applications in various countries, it is necessary to confirm the risks and toxicity of materials used in medical devices, including additives used in their manufacturing processes, and to understand the information for safe use. The revision of ISO 10993-1 in 2018 clarified the positioning of the comprehensive concept of biological safety evaluation, and in drug applications, it has become necessary to understand and practice a comprehensive biological evaluation process rather than merely conducting biocompatibility tests. This seminar will introduce the biological evaluation conducted based on ISO 10993-1, including its objectives, methods, and the biocompatibility tests carried out as part of the evaluation. By attending this seminar, you will be able to understand the regulatory requirements and related standards concerning biocompatibility evaluation, as well as the tests and analyses necessary for toxicity evaluation and their interrelationships. It is expected that a deeper understanding of evaluations and tests will facilitate smoother interactions with regulatory authorities, so please make use of this opportunity.
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Main revisions in ISO 10993-17: 2023 for the biological evaluation of medical devices.
In September 2023, ISO 10993-17 was revised for the first time in nearly 20 years. The ISO 10993 series of standards primarily deals with the biological evaluation of medical devices, and ISO 10993-17 specifies the requirements for the assessment of toxicological risks of substances identified through chemical characterization (ISO 10993-18). ISO 10993-17:2023 introduces new terms and concepts such as Toxicological Screening Limit (TSL), Estimated Exposure Dose (maximum; EEDmax), and release kinetics. It also provides a flowchart illustrating how the toxicological risk assessment framework can be integrated into the risk management process for medical devices and toxicological risk assessment reports. For further details, please refer to the "Related Links" below.
