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.