A Practical Guide to ISO 10993-5: Cytotoxicity

The international standards compiled as ISO 10993, and the FDA blue book memorandum (#G95-1) that is based on 10993-1, address the critical issue of ensuring device biocompatibility by identifying several types of tests for use in selecting device materials. Required for all types of devices, cellular toxicity testing is covered in 10993-5: "Tests for Cytotoxicity—In Vitro Methods." This standard presents a number of test methods designed to evaluate the acute adverse biological effects of extractables from medical device materials. In performing these tests, laboratory technicians culture mammalian cells, usually of mouse or human origin obtained from a commercial supplier, in flasks using nutrient culture media. (The Latin term in vitro refers to the culturing of cells "outside of the body," or literally "in glass.") The lab techniques involved are much like those used to grow bacteria. Cultured mammalian cells reproduce by cellular division and can be subcultured to produce multiple large flasks of cells for use in evaluating materials. This article in MD&DI's continuing series on ISO 10993 provides an overview of cytotoxicity testing and discusses the benefits of performing such procedures.