Review
The important role of material and chemical characterisation in device evaluation
Affiliations
- PMID: 15285481
Item in Clipboard
Review
The important role of material and chemical characterisation in device evaluation
Med Device Technol.
2004 Jun.
Abstract
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.
Similar articles
-
ISO 10993, Part 18: A structured approach to material characterisation.Med Device Technol. 2003 Jun;14(5):18-9. Med Device Technol. 2003. PMID: 12852116
-
Materials characterisation of Biomedical tents.Med Device Technol. 2005 Nov;16(9):16-8, 20. Med Device Technol. 2005. PMID: 16438443 Review.
-
Progress in testing.Med Device Technol. 2001 Sep;12(7):32. Med Device Technol. 2001. PMID: 12938558
-
Biological safety testing of polymers.Med Device Technol. 2003 Jun;14(5):12-5. Med Device Technol. 2003. PMID: 12852113
-
Biological evaluation of dental materials.Int Dent J. 1992 Feb;42(1):37-46. Int Dent J. 1992. PMID: 1563821 Review.
Cited by
-
Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices, Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products.J Diabetes Sci Technol. 2021 Jul;15(4):792-800. doi: 10.1177/1932296820908656. Epub 2020 Mar 1. J Diabetes Sci Technol. 2021. PMID: 32115999 Free PMC article.