Biomaterials in Design and Reliability of Medical Devices by Michael Nevin Helmus

By Michael Nevin Helmus

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Extra resources for Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit)

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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 Muscle and Bone; F622 Preformed Cranioplasty Plates that Can be Altered Silicone elastomer; Polyurethane; Silicone gel; Texture surfaces; Permeation barrier to silicone gel nonsilicone gel Hydrogels; Saline filled Tissue inflammation; fibrous capsule contracture; Rupture of shell; Tissue adhesion; Migration of device; Tissue erosion; Matching compliance of surrounding soft tissue; Leakage of gel Draft Guidance Preparation of FDA Submissions of Silicone Gel-Filled Breast Prostheses, Oct.

Degradation and loss of integrity can result from hydrolysis, including enzymatic hydrolysis, particularly in the polyurethanes and polyester-based copolymers. Degradation can also occur, as discussed, by oxidation from enzymes released in wound healing and from distortion and weakening from absorption of lipids. Polymeric materials are complex materials with ranges of molecular weights and utilizing additives to control polymerization, stability and processing. Standards developed by the International Standards Organization (ISO) have emphasized the characterization of leachables and degradation byproducts and their action on the body.

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 Biodegradable Polylactide Fracture Fixation Degradation rate vs. 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 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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