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Get to know ISO 10993 - part 5

ISO 10993 is a series of standards created for evaluating the biocompatibility of medical devices, which can range from dental implants to surgical masks, to manage biological risk. In reference to these standards, “biocompatibility” is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application."

Part five of these standards focuses on tests for in-vitro cytotoxicity, which is the quality of being toxic to cells. These tests are conducted with human or animal cell cultures and are required for all types of medical devices and assist in the selection of the materials used to make them.

Where it applies

ISO 10993 standards apply to select pharmaceutical products.

ISO 10993 - Avery Dennison

Objectives

  • Helping to determine the biocompatibility of medical devices

  • Preventing the use of devices that can damage human health

  • Identifying and quantifying the soluble and insoluble elements that may potentially be released from a medical device

Actions

  • Requires the use of cytotoxicity tests to verify if medical devices are safe to use 

  • Requires that tests are performed when creating a new device or changing an old one

What this means for you

If you work in the medical device industry, you may have to conduct certain tests on your products, or have a professional lab carry them out on your behalf.

ISO 10993 - Avery Dennison

How we can help

Our team of compliance experts can provide information about products that comply with ISO 10993 - part 5, making it easier to follow this regulation. Please reach out to your sales representative if you have any questions.