Biological evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the component materials of
The material used on the RAMP device and our single patient use Glide utilize an ISO 10993 compliant non-woven material that allows for direct skin contact and which mitigates potential shearing.
About the ISO 10993 Standards:
The biological evaluation of medical devices is currently governed by the set of standards developed by the International Organization for Standardization (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.” Characterization of medical device materials is thus clearly identified as one of the ﬁrst steps in their overall evaluation.
Our material has passed both of these Level 1 tests on human volunteers:
ISO 10993–10: Sensitization Test
The Kligman Maximization 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 sensitization reaction to the test article is scored based on the defined evaluation criteria in ISO 10993-10.
ISO 10993–10: Irritation Test
Test is designed to evaluate local responses to solutions or extracts . The test article will be exposed to the skin directly. Observations are scored according to the Classification System for Scoring Skin Reactions (Draize scale). At the end of the observation period the scores are used to determine an overall mean reaction score for the test article versus the corresponding control article. The requirements of the test are met if the difference of the mean reaction score for the test article and the control article is 1.0 or less.