Jordi Labs

How We Conduct ISO 10993 Medical Devices Evaluations

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E&L Testing analytical chemistry testing on medical devices such as a Traumatology and orthopedic surgery prosthetic titanium hip implant.

Image of Quality Policy: Jordi Labs aims to provide the highest quality products and services to the polymer, pharmaceutical, nanotechnology, and biotechnology industries. Quality is central to who we are as a company. Jordi Labs’ existence depends on the quality designed into each of our products and specialized analytical testing processes, by every employee instilled with pride, working together and sharing what we learn with one another. We have an ISO 9001 quality system that we continuously improve while seeking to improve customer satisfaction.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.

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