This guidance introduces significant updates and expectations for chemical analysis in the context of biocompatibility evaluations, aligning with global
regulatory trends and emphasizing the importance of rigorous safety assessments.
The International Organization for Standardization (ISO) has announced the upcoming release of the revised ISO 10993-1: Biological Evaluation of Medical
Devices — Part 1: Evaluation and Testing Within a Risk Management Process in 2025.
The ISO 18562 series of standards, which governs the biocompatibility evaluation of breathing gas pathways in healthcare applications, has undergone a significant revision in its 2024 edition. These updates introduce important changes that reflect advancements in testing methodologies, regulatory expectations, and the safety of medical devices.
This case study looks at remediating biocompatibility workflows to meet EU MDR compliance requirements. CLIN-r+ supported the manufacturer with their problematic biocompatibility workflows to address audit findings and deficiencies and pass the second NB assessment.
Recent changes to ISO 10993-1 have changed the landscape of medical device biological safety testing. The toxicity test box ticking from the biocompatibility test matrix is no longer used. Materials analysis, chemical risk analysis, analytical chemistry, and toxicological risk analysis have all been introduced. Clin-r+ explains what you need to know.
The Toxicological Risk Assessment and Biological Evaluation documentation will undergo significant modifications with the release of the much awaited revisions in this area. Clin-r+ highlights the changes made in 2023 to toxicology and biological evaluation that manufacturers need to be aware of, and what it means for the documentation required to be compliant.
ISO standards help medical device manufacturers and the medical industry comply with the evolving ‘State of the Art’, international best practices, streamline processes, and improve patient safety and satisfaction. These standards improve risk management and help businesses fulfil legal and industry standards. There are numerous ISO standards in place, and Clin-r+ has constructed this paper to give you an overview of the most common standards for the MedTech industry.
What is biocompatibility for a medical device?
Why is it needed? What does it do?
We have all the answers and more…
ISO 18562, has become the industry standard for testing the biocompatibility of breathing components. It has four parts: general principles, evaluation of particle emission, evaluation of volatile gas emission, and evaluation of liquid bourn leachables in condensate. Clin-r+ provides an in-depth breakdown of these four components of the standard.
Biocompatibility and how to apply extractables and leachables to medical devices. ISO 10993 now requires knowledge of any chemicals released by a device while it is in use. This is now included in the testing matrix for each device category. Although materials characterisation isn’t the only way to get this information, it’s the most likely way to discover unexpected materials.
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