ISO 10993 Compliance Made Simple: 5 Key Steps to Pass Biocompatibility Testing
Biocompatibility tests following ISO-10993 are critical if you wish to get your medical device to the market. It is a standard that the manufacturers must follow to meet the medical devices' safety needs; it has a factor in the body interaction. Biocompatibility for medical devices has to function in the way intended and not cause any bad effects when it interacts with the human body. Here are five steps to help you navigate the biocompatibility testing process more effectively: 1. Get to Know With the ISO 10993 Testing Unfortunately, errors can occur if you do not know all the details about ISO 10993 testing before starting. Currently, the standard provides a list of tests that are relevant for assessing the biological risk of medical devices. The ISO 10993 guideline is very broad and encompasses several areas; thus to get a picture of the various tests suitable for a specific device is crucial. 2. Choosing the Appropriate Tests for Your Device ISO 10993 does not ...