Understanding Biocompatibility of Medical Device ISO 10993
The word biocompatibility refers to the interaction of a medical device and tissues and physiological systems of a patient treated with the device. An evaluation of biocompatibility is one part of the overall safety assessment of a device. Biocompatibility of device is investigated using analytical chemistry, in-vitro test and animal models. The biocompatibility of a device depends on several factors, including:
the chemical and physical nature of its component materials the type of patient tissue that will be exposed to the device the duration of that exposure While in use, substance may leach off of a medical device into adjacent tissue. Some leachables or extractables are not biologically safe.
Many of the various biocompatibility tests include sample preparation steps designed to rinse the leachable and extractable from the device. The extract is then tested. The actual device material may be used in some other tests.
The primary purpose of a device biocompatibility assessment is to protect the patient safety. The best starting point for understanding biocompatibility requirement is ISO 10993, Biological Evaluation of Medical Devices. A list of the individual section of ISO 10993 is shown as below:
Part 1Evaluation and testingPart 2Animal welfare requirementsPart 3Tests for genotoxicity, carcinogenicity and reproductive toxicityPart 4Selection of tests for interactions with bloodPart 5Tests for in vitro cytotoxicityPart 6Tests for local effects after implantationPart 7Ethylene oxide sterilization residualsPart 8Selection and qualification of reference materials for biological testsPart 9Framework for identification and quantification of potential degradation productsPart 10Tests for irritation and delayed-type hypersensitivityPart 11Tests for systemic toxicityPart 12Sample preparation and reference materialsPart 13Identification and quantification of degradation products from polymeric medical devicesPart 14Identification and quantification of degradation products from ceramicsPart 15Identification and quantification of degradation products from metals and alloysPart 16Toxicokinetic study design for degradation products and leachablesPart 17Establishment of allowable limits for leachable substancesPart 18Chemical characterization of materialsPart 19Physico-chemical, morphological and topographical characterization of materialsPart 20Principles and methods for immunotoxicology testing of medical devices If you are eager to ensure the safety of your medical device, SGS Hong Kong can help to provide you an answer. Contact us now!
Alan Ng (Life Science)t: + 852 2609 9611 (ext 3353)
f: + 852 2603 7577
Systems and Services Certification
t: + 852 2765 3620
f: + 852 2333 2257
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.