ISO 10993 covers a range of international standards for the assessment of biomedical devices and related biological risks. ISO 10993 includes specific standards for certain material classes, such as ceramics or metals, as well as assessment and testing within a risk-managed process.
It is important to follow ISO 10993 standards and guidance when developing new medical devices. The ISO 10993 standard covers all aspects of the development process, from advice on the assessment of existing risk data to the preparation of necessary test protocols for new materials or where existing data are missing.
The inclusion of ‘expert examiners’ in the interpretation of biological assessment data and biological risk assessment is recommended as part of ISO 10993:1. It is important to determine which tests can be waived when existing data are available and in the design and performance of new tests as required by ISO 10993.
Jordi Labs can assist you by understanding ISO 10993 standards and by performing and designing any new tests required for new materials or equipment. Jordi Labs with over 40 years of expertise in extractables and leachables testing, chemical characterization and biological risk consulting is the right partner to bring your device to market quickly and safely.
Biocompatibility and ISO 10993
An important part of ISO 10993 standards is to establish biocompatibility and biological risk. Biocompatibility means that the material and any potential degradation or leaching products do not pose a risk to human health.
ISO 10993:1 outlines the different types of tests that need to be done for a device depending on how long and where it will be used in the patient’s body. For example, the contact duration of a device is divided into three categories, limited (<24 घंटे), लंबे समय तक (> 24 hours to 30 days) and longer duration (>30 days).
Carcinogenicity tests need to be performed only on materials and equipment intended for prolonged use. Jordi Labs can help you navigate all of the specifications that need to be tested for your application and help with the evaluation of existing risk data and what actions to take as part of a risk management plan. is required.
An important part of testing that is often required as part of the biomedical risk assessment in ISO 10993 is extractables and leachables testing. ISO 10993 outlines specific guidance for how to test extractables and leachables to provide an appropriate exacerbation of the biological environment.
Jordi Labs has extensive extractable and leachable testing capabilities and can provide test plans to provide the appropriate range of biological conditions; Includes toxicity risk assessment and identification and quantification of degradation products required as part of sections 16 and 9 of ISO 10993.