Biomedical Engineering Theory And Practice/Requirements of Biomaterials
Requirements for Biomaterials
Table 3. Biological Tissue:Mechanical Properties
|Tissue||Modulus(GPa)||Tensile Strength(MPa)||Strain at Break(%)|
|Cortical bone(longitudinal direction)||17.7||133||1-3|
|Cortical bone(transverse direction)||12.8||52||1-3|
|Tissue||Modulus(MPa)||Tensile Strength(MPa)||Strain at Break(%)|
Table 2.How to measure mechanical properties of engineering biomaterials 
According to Nancy J. Stark,there are commonly three stories in which manufacturers call on CDG for biocompatibility: a) FDA has brought up questions about the safety tests you performed, b) you can decide whether you need sensitization, genotoxicity, or carcinogenicity tests, or not, c) you have a new device and don't have a clue as to what tests to do. Can an expert opinion help?
Table .List of the standards in the 10993 series for biocompatibility evaluation
|ISO 10993-1:2009||Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process|
|ISO 10993-2:2006||Biological evaluation of medical devices Part 2: Animal welfare requirements|
|ISO 10993-3:2014||Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity|
|ISO 10993-4:2002/Amd 1:2006||Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood|
|ISO 10993-5:2009||Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity|
|ISO 10993-6:2007||Biological evaluation of medical devices Part 6: Tests for local effects after implantation|
|ISO 10993-7:2008||Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals|
|ISO 10993-8:2001||Biological evaluation of medical devices Part 8: Selection of reference materials (withdrawn)|
|ISO 10993-9:1999||Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products|
|ISO 10993-10:2010||Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity|
|ISO 10993-11:2006||Biological evaluation of medical devices Part 11: Tests for systemic toxicity|
|ISO 10993-12:2012||Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)|
|ISO 10993-13:1998||Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices|
|ISO 10993-14:2001||Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics|
|ISO 10993-15:2000||Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys|
|ISO 10993-16:1997||Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables|
|ISO 10993-17:2002||Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances|
|ISO 10993-18:2005||Biological evaluation of medical devices Part 18: Chemical characterization of materials|
|ISO/TS 10993-19:2006||Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials|
TABLE 5. Ethical Concerns Relevant to Biomaterials Science
|Is the use of animals justified? Specifically, is the experiment well designed and important so that the data obtained will justify the suffering and
sacrifice of the life of a living creature?
|How should research using humans be conducted to minimize risk to the patient and offer a reasonable risk-to-benefit ratio? How can we best ensure informed consent?|
|Companies fund much biomaterials research and own proprietary biomaterials. How can the needs of the patient be best balanced with the financial goals of a company? Consider that someone must manufacture devices—these would not be available if a company did not choose to manufacture them.|
|Since researchers often stand to benefit financially from a successful biomedical device and sometimes even have devices named after them, how can investigator bias be minimized in biomaterials research?|
|For life-sustaining devices, what is the trade-off between sustaining life and the quality of life with the device for the patient? Should the patient be permitted to “pull the plug” if the quality of life is not satisfactory?|
|With so many unanswered questions about the basic science of biomaterials, do government regulatory agencies have sufficient information to define adequate tests for materials and devices and to properly regulate biomaterials?|
|Should the government or other “third-party payors” of medical costs pay for the health care of patients receiving devices that have not yet been
formally approved for general use by the FDA and other regulatory bodies?
|Should the CEO of a successful multimillion dollar company that is the sole manufacturer a polymer material (that is a minor but crucial
component of the sewing ring of nearly all heart valves) yield to the stockholders’ demands that he/she terminate the sale of this material because of litigation concerning one model of heart valve with a large cohort of failures? The company sells 32 pounds of this material annually, yielding revenue of approximately $40,000?
|Should an orthopedic appliance company manufacture two models of hip joint prostheses: one with an expected “lifetime” of 20 years (for young,
active recipients) and another that costs one-fourth as much with an expected lifetime of 7 years (for elderly individuals), with the goal of saving resources so that more individuals can receive the appropriate care?
- Black J, Hastings GW. Handbook of Biomaterials Properties. London, UK: Chapman and Hall, 1998
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- >"Medical Device Biocompatibility". http://clinicaldevice.typepad.com/cdg_whitepapers/biological-safety/. Retrieved 31 May 2011.
- "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo)". FDA. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm. Retrieved 12 December 2014.
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