Current and future issues in sensitisation testing.
Sensitisation is one of the biological risks that needs to be addressed for any medical device before clearance or clinical evaluation. This article describes the state of the art for this evaluation and also new variants of the procedure to increase the accuracy of these tests, particularly when some metals, latex-based products and macromolecular proteins such as collagen are concerned.
Eloy
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Biomatech/NAMSA, Zone Industrielle de l'Islon, 115 rue Pasteur, F-38670 Chasse sur Rhône, France.
Charton-Picard
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Delubac
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Kergozien
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D003877:Dermatitis, Contact / Q000145:classification / Q000175:diagnosis* / Q000517:prevention & control*; D018795:Device Approval / Q000592:standards*; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards; D004869:Equipment Safety / Q000592:standards / Q000639:trends; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D008422:Materials Testing / Q000379:methods / Q000592:standards; D012882:Skin Tests / Q000379:methods* / Q000592:standards* / Q000639:trends