The important role of material and chemical characterisation in device evaluation.
Parts 18 and 19 of ISO 10993, Biological Evaluation of Medical Devices, currently in draft, are receiving even more emphasis as they become an integral part of the biological safety evaluation of biomaterials and medical devices. An important step in this process is the characterisation of the material and identification of chemicals that can migrate or extract from the polymer components. This article discusses which tests will meet the requirements.
Albert
David E
DE
NAMSA, Northwood, Ohio 43619, USA. dalbert@namsa.com
D001672:Biocompatible Materials / Q000032:analysis / Q000737:chemistry* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000379:methods* / Q000592:standards*; D017408:Guidelines as Topic; D038622:Internationality; D008422:Materials Testing / Q000379:methods* / Q000592:standards*; D008970:Molecular Weight; D011785:Quality Assurance, Health Care / Q000379:methods / Q000592:standards; D013696:Temperature; D014481:United States
D001672:Biocompatible Materials