Biomedical Engineering Reference
In-Depth Information
Eckstein F S, Twvaearai H, Keller D, et al. (2004), `Early clinical experience with a new
tubular equine pericardial stentless aortic valve', Heart Surg Forum, 7, E498±502.
EMEA (2004), `Note for guidance on minimising the risk of transmitting animal spongiform
encephalopathy agents via human and veterinary medicinal products', EMEA/410/01
Rev 2, adopted by the Committee for Proprietary Medicinal Products (CPMP) and by
the Committee for Veterinary Medicinal Products (CVMP), 2004/C 24/03.
Erdtmann R and Sivitz L B (2004), `Advancing prion science: guidance for the national
prion research program', Washington DC, The National Academies Press.
Fisher J and Wheatley D J (1987), `An improved pericardial bioprosthetic heart valve.
Design and laboratory evaluation', Eur J Cardiothorac Surg, 1, 71±9.
Flameng W, Meuris B, Yperman J, et al. (2006), `Factors influencing calcification of
cardiac bioprostheses in adolescent sheep', J Thorac Cardiovasc Surg, 132, 89±98.
Flameng W, Meuris B, DeVisscher G, et al. (2008), `Trilogy pericardial valve:
hemodynamic performance and calcification in adolescent sheep', Annals Thorac
Surg, 85, 587±92.
Flameng W, Herregods MC, Vercalsteren M, et al. (2010), `Prosthesis-patient mismatch
predicts structural valve degeneration in bioprosthetic heart valves', Circulation,
121, 2123±9.
Gibbons D (1980), `Final Report: Effect of surface texture by ion beam sputtering on
implant biocompatibility and soft tissue attachment', NASA-CR-1; 76517.
Gibbons J (2009), Internal data on file, Southern Lights Biomaterials, www.slv.co.nz.
Girardot J M (1990), `Prevention of prosthesis calcification', US Patent 4,976,733, issued
December 11, 1990.
Gott J P, Chih P, Dorsey L M A, et al. (1992), `Calcification of porcine valves: a
successful new method of antimineralization', Ann Thorac Surg, 53, 207±16.
Harasaki H, Kiraly R, Nose Y (1986), `Three mechanisms of calcification in tissue
valves', in Yacoub M and Bodnar E, Biologic & Bioprosthetic Valves, New York,
Yorke Medical Books, 433±41.
Hartz R S, Fisher E B, Finkelmeier B, et al. (1986), `An eight-year experience with
porcine bioprosthetic cardiac valves', J Thoracic Cardiovasc Surg, 91, 910±17.
Ionescu M I, Tandon A P, Silverton N P, et al. (1986), `Long-term durability of the
pericardial valve', in Yacoub M and Bodnar E, Biologic & Bioprosthetic Valves,
New York, Yorke Medical Books, 165±76.
Ishihara T, Ferrans V J, Boyce S W, et al. (1981), `Structure and classification of cuspal
tears and perforations in porcine bioprosthetic cardiac valves implanted in patients',
Am J Cardiology, 48, 665±78.
ISO 5840 (2005), `Cardiovascular implants ± cardiac valve prostheses,' available at
www.iso.org.
ISO 10993-1 (1997), `Biological evaluation of medical devices ± evaluation and testing,'
available at www.iso.org.
ISO 11134 (1994), `Sterilization of healthcare products ± requirements for validation and
routine control ± industrial moist heat sterilization,' available at www.iso.org.
ISO 11607 (2003), `Packaging for terminally sterilized medical devices,' available at
www.iso.org.
ISO 13485, `Medical devices ± quality management systems ± requirements for
regulatory purposes,' available at www.iso.org.
ISO 14155-1 (2003), `Clinical investigation of medical devices for human subjects ± Part
1: general requirements,' available at www.iso.org.
ISO 14630,
￿ ￿ ￿ ￿ ￿
`Non-active surgical
implants ± general
requirements,' available at
www.iso.org.
Search WWH ::




Custom Search