ISO Biocompatability testing
Levabo® all up® and heel up® have passed ISO 10993 biocompatibility testing.
This is a major accomplishment, given this ISO test is considered to be more stringent and more widely accepted within the medical device community worldwide than even USP Class VI. Below, we have provided you with some details about the ISO 10993 certification. Please familiarise yourselves with the information, as you may be asked about it by your customers. If you have any questions, as always, please contact us directly.
About the ISO 10993 Standards:
Materials characterisation forms the basis for understanding the composition of a medical device material. It also serves as a means- to ensure standardisation of materials from one lot of devices to the next. As the harmonisation of ISO 10993 standards and FDA requirements proceeds, the methods described is used by the U.S. device industry to a greater and greater extent to aid in the selection of optimal materials and to control the uniformity of medical products.
The biological evaluation of medical devices is currently governed by the set of standards developed by the International Organisation for Standardisation (ISO) and known as ISO 10993 or, in the United States, by FDA blue book memorandum #G95-1, which is a modification of ISO 10993-1, “Guidance on Selection of Tests.” ISO 10993-1 states that “in the selection of materials to be used in device manufacture, the first consideration should be fitness for purpose having regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological, and mechanical properties.” Characterisation of medical device materials is thus clearly identified as one of the first steps in their overall evaluation.
ISO 10993–10: Sensitisation Test
The Kligman Maximisation Test evaluates the allergenic potential or sensitizing capacity of the test article in humans. The test article will be exposed to the skin directly .
A sensitisation reaction to the test article is scored based on the defined evaluation criteria in ISO 10993-10.