Conducting ISO 10993 Medical Devices Evaluations

The primary aim of ISO 10993 is establishing a set of standards that safeguard and protect patients from biological risks associated with the use of medical devices. The standards address testing methods for carcinogenicity, genotoxicity, cytotoxicity and a wide range of other areas of interest.  

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While confronting key areas of interest and testing to be assessed, the standards are intended to provide a framework for a biological evaluation, not a detailed taxonomy of essential testing and specifications. Jordi Labs ensures consistency and adherence to the regulations when assisting clients in any design processes as well as committing to the same standards for analytical testing involved in the assessment of medical devices under ISO 10993.

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Jordi’s chemists follow and observe the appropriate guidance provided in ISO 10993-12 for conducting studies relative to various extractables and leachables for medical device testing. Further information concerning the appropriate selection of analytical methods for chemical characterization is given in ISO 10993-18. Additional sections of ISO 10993 that Jordi Labs follows for suitable guidance to assist clients in the assessment of medical devices are included below.

Part 1: Evaluation and testing within a risk management process
Part 12: Sample preparation and reference materials
Part 13: Identification and quantification of degradation products from polymeric medical devices
Part 14: Identification and quantification of degradation products from ceramics
Part 15: Identification and quantification of degradation products from metals and alloys
Part 18: Chemical characterization of medical device materials

For additional information on how Jordi Labs’ chemists can provide assistance with your regulatory requirements, see Regulatory Testing Services.

This information has been sourced, reviewed and adapted from materials provided by Jordi Labs.

For more information on this source, please visit Jordi Labs.

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