Design and manufacture of a multiple material sample for implantation testing of thermoplastic materials used in a medical device

Polymer Testing

Volumn 24, Issue 6, 2005, Pages 684-687

  Dunne, Paul ^a  

^a Aerogen Ltd   (Ireland)

Author keywords

Biocompatibility; Biological evaluation; Implantation testing; ISO 10993; Thermoplastics

Indexed keywords

ADHESIVES; BIOMEDICAL EQUIPMENT; COST EFFECTIVENESS; DATA ACQUISITION; INJECTION MOLDING; PLASTICS;

BIOLOGICAL EVALUATION; IMPLANTATION TESTING; ISO 10993; THERMOPLASTIC MATERIALS;

THERMOPLASTICS;

EID: 23844519821     PISSN: 01429418     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.polymertesting.2005.06.003     Document Type: Article

References (12)

1. Food and Drug Administration. Premarket approval of medical devices. 21 CFR 814.20; 1996.
2. G. Kotzar, M. Freas, P. Abel, A. Fleischman, S. Roy, C. Zorman, J.M. Moran, and J. Melzak Evaluation of MEMS materials of construction for implantable medical devices Biomaterials 23 13 2002 2737 2750 July
3. International Standards Organisation. Biological evaluation of medical devices - Part 1 Evaluation and Testing. ISO 10993-1. Geneva; 2003.
4. K. Rodgers, P. Klykken, J. Jacobs, C. Frondoza, V. Tomazic, and J. Zelikoff Immunotoxicity of medical devices Fundamental Appl Toxicol 36 1 1997 1 14 March
5. Tarrant H, Caulfield C. Biocompatibility and Toxicological Considerations. Chapter 5. Medical Devices Manual. Euromed Communications. ISSN 1460-8375; 1998.
6. International Standards Organisation. Biological evaluation of medical devices - Part 6 Tests for local effects after implantation. ISO 10993-6. Geneva; 1998.
7. International Standards Organisation. Biological evaluation of medical devices - Part 12 Sample preparation and reference materials. ISO 10993-12. Geneva; 2002.
8. R. Wallin, P. Upman, and A. Practical A practical guide to ISO 10993-11: systemic effects Med Device Diagnos Ind 1998
9. Lustran ABS 348 Datasheet. Bayer Corporation. Document Number 12/02. 2002.
10. Chemlok 487A/B Datasheet. Lord Chemical Products. Document Number DS9487; 1998.
11. Santoprene 8000 Rubber Series General Product Information. Advanced Elastomer Systems. Document Number TCD01098; 1998.
12. H. Lee, S. Kim, and G. Khang Polymeric biomaterials. Chapter 42 J. Bronzino The Biomedical Engineering Handbook 1995 CRC Press 581 597 ISBN0 8493 8346 3