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. RQM+ Lab Services routinely assists its clients in the design and analytical testing involved in the evaluation of medical devices under ISO 10993.

RQM+Lab'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 RQM+ Lab Services 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 RQM+ Lab’s chemists can assist with your regulatory requirements, contact us today.


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