To complement the recent release of the new ISO/TS 17137, there’s also a new ISO/TR 37137 on the same topic. This Technical Recommendation is titled “Cardiovascular biological evaluation of medical devices – Guidance for absorbable implants.” It should be used in conjunction with the various parts of the ISO 10993 series, to account for intentional release of soluble materials.
The concern here is the possibility of problems caused by the absorbable materials themselves. The guidance document has been generated to provide you, the user, with more information on the issue and potential approaches to this problem. As a Technical Recommendation, the science behind the document appears to be evolving. This means that this is a preliminary take on the issue, subject to change as more experience is gained.
Again, we are taking about a substance (foreign material) introduced into the patient by the medical device that is intended to pass through or be absorbed by cells and/or tissue over time. This could even be material introduced by leaching or the degradation of the device itself. The goal is to minimize or avoid an adverse reaction to the release of any material introduced by a medical device.
The document covers 3 types of considerations facing a medical device manufacturer. They are general considerations, sterilization considerations, and what’s call drug-device combination considerations.
But the bulk of the 22-page document covers each section of the ISO 10993 series on the biological evaluation of medical devices. For each part, a description of areas in the standard that have absorbable related issues are reviewed and discussed. For example, in ISO 10993-3, the section you should be looking at is clause 4.4 (test methods, genotoxicity tests). ISO/TR 37137 provides supplemental information for section 4.4.1 that can help you evaluate additional methods for addressing identifying and measuring possible absorption.
These two new standards, ISO/TR 37137 and ISO/TS 17137, effectively extend the coverage of the ISO 10993 series by addressing additional types of toxicity concerns beyond irritation and skin sensitivity. I had thought that perhaps this would help address some of the concerns raised by the Annexes in the European adoptions of the ISO 10993 series. But upon investigation, I note that these 2 new items are not currently in the pipeline for adoption as EN standards.
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