The goal of ISO 10993 is to protect patients from biological risks arising from the use of medical devices. The standard covers testing for genotoxicity, carcinogenicity, cytotoxicity and a variety of other areas of concern. While the standard covers specific areas of testing to be evaluated, it is meant to be a framework for a biological evaluation, not a list of required testing and specifications. Jordi Labs routinely assists its clients in the design and analytical testing involved in the evaluation of medical devices under ISO 10993.
Jordi’s chemists follow the guidance for performing extractables and leachables studies provided in ISO 10993-12 for medical device testing. Additional information regarding the proper selection of analytical methods for chemical characterization is provided in ISO 10993-18. Below are other areas of ISO 10993 that Jordi Labs uses for guidance to assist its clients in the evaluation of their medical devices.
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 materials
For more information on how Jordi Labs’ chemists can assist with your regulatory requirements, see our Regulatory Testing Services.