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.


3) 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.

Levels of Biocompatibility

Medical Device Manufacturers characterise/qualify materials and devices by Levels of Biocompatibility. They will refer to them as Level 1, Level 2 and Level 3. You might be asked the question by a medical device company: what level of testing did Levabo® all up® and heel up® pass for ISO 10993? The answer is Level 1 (Cytotoxicity, Sensitisation and Irritation). Below is a description of the various Levels:

Level 1 tests provide the device manufacturer information on the physical, chemical and toxicological characterisation of the materials being considered for use in their medical device or prototype. These tests are considered the initial characterisation of biomaterials and serve as the foundation for all other testing conducted for their medical device/prototype. Materials that pass have broad applications. These materials are characterised as “recommended for use” during the early stages of medical device development.

Level 2 tests are acute toxicity tests and some subchronic and chronic testing (special testing due to complexity and/or intended use of the device). Simply put, it is an extension of Level 1 with additional in-vitro and in-vivo testing of devices. A Level 1 study should be completed prior to conducting all level 2 testing.

Level 3 testing is the highest level of testing for a medical device and involves clinical studies. This is especially important for implantable devices.

Have questions regarding ISO 10993 certification for Levabo® all up® and heel up® materials?

Please contact: Peter Egelund