ISO 10993 is a standard for evaluating the biocompatibility of medical devices to ensure patient safety. It includes 20 tests for everything from irritation to interactions with blood. The standard uses animal models, in vitro tests, and analytical chemistry to evaluate devices based on their chemical and physical composition. Manufacturers, regulatory authorities, and laboratories must comply with the standard. Tests include checking for local effects, residues, and systemic toxicity. Experts should use their own judgment in selecting relevant procedures and explain any deviations from the prescribed methodologies.
ISO 10993 is a standard developed by the International Standards Organization (ISO) to evaluate the biocompatibility of medical devices in an effort to ensure patient safety. Established in 1995, this standard creates guidelines for biocompatibility testing globally. It’s a 20-part standard that tests everything from irritation to delayed hypersensitivity to interactions with blood and the chemical properties of the materials involved. It can generally be understood as a set of tests and principles that evaluate medical devices to ensure that there are no adverse effects to the human body as a result of their use.
It is essential to thoroughly evaluate the biocompatibility of medical devices: different devices can have different types of interactions with the body’s tissues and organs. For example, a material may leak from the medical device into surrounding tissue or inadvertently enter the bloodstream. Some of these items may not be secure. The ISO 10993 standard uses animal models, in vitro tests and analytical chemistry to perform the assessment. Devices are evaluated based on their chemical and physical composition, the types of tissue they come into contact with, and the length of overall exposure.
By providing guidelines on the types of tests needed, ISO 10993 helps to understand and evaluate the data obtained. It also helps identify areas where more information is needed and helps pinpoint gaps using risk analysis methodologies. All medical device manufacturers, regulatory authorities and laboratories must comply with the ISO 10993 standard. Devices are classified as implant, surface or external communicating and are further subdivided according to the duration of exposure. Limited exposure stays for less than 24 hours, extended exposure is considered anything between a day and a month, and permanent exposure for more than a month.
Some of the tests involved in ISO 10993 include checking for local effects after a device is implanted inside the body, the presence of any residues and how materials such as ceramics, metals and polymers degrade with exposure to the body. Each test is important for numerous reasons. For example, one test involves evaluating systemic toxicity. This is to investigate whether the device releases materials into the body and, if so, in what concentrations. If the concentration is too high, it could be absorbed and circulated to different areas, resulting in extreme toxic effects.
Experts using ISO 10993 to test for systemic toxicity should use their own judgment in selecting relevant procedures from lists of standards to ensure they apply to the device under test. There is room for judgment in the application of these standards because excessive stringency or overly detailed specifications may prevent the expert from applying the most relevant test methodologies. If they deviate from the prescribed methodologies set out in the standard, they must explain the rationale behind their test methods and show sufficient scientific support for their decisions.
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