New PDF release: Biomaterials in Design and Reliability of Medical Devices

By Michael Nevin Helmus

ISBN-10: 1587060396

ISBN-13: 9781587060397

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Additional info for Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit)

Sample text

Medical Device and Diagnostic Industry, June 1998:58. 13 Detailed description of sterilization methodologies and medical device infections can be found in "Disinfection, Sterilization, and Preservation" Seymour Block, ed. Lippincott, Williams & Wilkins, 2000.

3. 3. 3. 3. 3. continued Device Materials of Materials Related Construction: Predicate Design Issues Devices and Corporate Devices/ Bill of Materials Standards/ Guidelines FDA Standards/ Guidelines ASTM, ANSI Standards/ Guidelines ISO Guidance Document Approval Requirements for IOLs with an Extended Power Range Electrode and insulation material; Engineering plastic housing or metallic alloy housing Soft and hard tissue compatibility; Chronic tissue irritation of soft tissue and adhacent nerves Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years; Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Adults at Least 18 years of age.

Continued Device Materials of Materials Related Construction: Predicate Design Issues Devices and Corporate Devices/ Bill of Materials Standards/ Guidelines FDA Standards/ Guidelines ASTM, ANSI Stainless steels; Cobalt Chrome alloys; Titanium alloys; Carbon fiber reinforced Polysulfone or Polyetheretherkeytone bone fragments; Stress transfer; Stiffness; Resistance to bending and torsion; Fretting corrosion; Stress shielding, Bone resorption; Carbon fiber release and tissue irritation Device Systems; Draft Guideline for Reviewing Spinal Fixation Device Systems; Draft Guideline for Reviewing Pedicle Screw Spinal Fixation Device Systems Intended for Severe Spondylolisthesis Polysulfone Resin for Medical Applications; F1582 Spinal Implants; F1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Dental Stainless steels; Cobalt Chrome alloys; Titanium alloys; Nickel-based alloys; Cobalt Alloys; Gold Alloys; Calcium phosphate; Hydroxyapatite and Bioglass coatings and bone fillers; Porous coatings Integration with bone and soft tissue; Matching bone modulus; Bone/softtissue/oral interface; Formation of bone vs.

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Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit) by Michael Nevin Helmus


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