Biological safety testing of polymers.
The extent of testing polymer-containing medical devices is subject to a range of considerations and needs to be determined on a case-by-case basis. This article reports on recent areas of concern for device materials including biodegradation and immunogenicity potential.
Baldrick
Paul
P
Scientific and Regulatory Consultancy Group, Covance Laboratories Ltd, Harrogate HG3 1PY, UK. paul.baldrick@covance.com
D020341:Absorbable Implants / Q000592:standards; D015197:Carcinogenicity Tests / Q000379:methods / Q000592:standards; D003270:Contraceptive Agents / Q000592:standards; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards; D004869:Equipment Safety / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005549:Foreign-Body Reaction / Q000517:prevention & control; D006801:Humans; D007391:International Cooperation; D008422:Materials Testing / Q000379:methods* / Q000592:standards*; D011108:Polymers / Q000592:standards*; D012015:Reference Standards
D003270:Contraceptive Agents; D011108:Polymers