ISO 10993 comprises a series of international standards for the evaluation of biomedical devices and associated biological risk. ISO 10993 includes specific standards for certain material classes, such as ceramics or metals, as well as evaluation and testing within a risk-managed process.
Following ISO 10993 standards and guidance is crucial when developing new medical devices. The ISO 10993 standard covers all aspects of the development process, from advice on evaluating existing risk data to designing necessary testing protocols for new materials or where existing data is missing.
As part of ISO 10993:1, the recommendation is to involve ‘expert testers’ in the interpretation of biological evaluation data and the biological risk assessment. This is crucial for determining which tests can be waived when existing data is available and in the design and performance of new tests as required by ISO 10993.
Jordi Labs can help support you by understanding the ISO 10993 standards and performing and designing any new necessary testing for new materials or devices. Jordi Labs is the right partner to bring your device to market quickly and safely with over 40 years of expertise in extractables and leachables testing, chemical characterization, and biological risk consulting.
Biocompatibility and ISO 10993
A significant part of the ISO 10993 standards is establishing biocompatibility and biological risk. Biocompatibility means the material and any potential degradation or leaching products do not pose risk to human health.
ISO 10993:1 outlines the different types of testing that need to be carried out for a device depending on how long and where it will be used in the patient’s body. For example, the contact duration of the device is divided into three categories, limited (< 24 hours), prolonged ( > 24 hour to 30 day) and long term (> 30 days).
Carcinogenicity tests only need to be performed on materials and devices for long term use. Jordi Labs can help you navigate all the specifics of which testing needs to be performed for your application and help with the evaluation of existing risk data and what work needs to be performed as part of a risk management plan.
An important part of the testing that is often required as part of the biomedical risk evaluation in ISO 10993 is extractables and leachables testing. ISO 10993 outlines specific guidance for how to conduct extractables and leachables testing to provide a suitable exaggeration of the biological environment.
Jordi Labs has extensive extractables and leachables testing capabilities and can provide testing schemes to provide suitable exageration of the biological conditions; including toxicological risk assessment and identification and quantification of degradation products required as part of sections 16 and 9 of ISO 10993.