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Medical device design and regulations

Last Updated: 17-Sep-2012

This guide is a starting point for research on design of medical devices and medical device regulation including resources for finding standards and materials.

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Sarah Lester
Engineering Librarian for Outreach, Instruction and Electronic Resources
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Article resources

Journals

Fairfield, NJ : American Society of Mechanical Engineers, 2007-
[London ; Birmingham, Ala. : Published for the Institution by Mechanical Engineering Publications Ltd.], c1989-
SAL3 » Stacks » R856 .A1 P76 F V.219 2005
New York, NY : Marcel Dekker, Inc., 1994-
SAL3 » Stacks » QD61 .C4 V.27 1999
Frederick, MD : Aspen Publishers Hagerstown, MD : Lippincott Williams & Wilkins

Research databases

[New York?] : Thomson Reuters.

This database covers the entire field of life sciences including original research reports and reviews in field, laboratory, clinical, experimental, and theoretical work. BIOSIS indexes journals, technical reports, meeting proceedings, United States patents, and books in biology, biomedicine, and related areas.

New York [etc.]
SAL3 » Stacks » Z5851 .E62 1906

Contains over 9 million records and references over 5,000 international engineering sources including journal, conference, and trade publications. Also known as Compendex.

[Piscataway, N.J.?] : IEEE, c1998-

Provides full-text access to the publications of both the Institute of Electrical and Electronics Engineers (IEEE) and the Institution of Electrical Engineers (IEE); includes all journals, magazines, standards and conference proceedings. Publications include IEEE Transactions on Biomedical Circuits and Systems, IEEE Reviews in Biomedical Engineering, and IEEE Transactions on Biomedical Engineering.

[United States] : Institution of Electrical Engineers, INSPEC service, [19--]-

Provides a comprehensive index to the published literature in physics, electrical/electronic engineering, computing, control engineering, information technology, production, manufacturing and mechanical engineering as well as materials science, oceanography, nuclear engineering, geophysics, biomedical engineering and biophysics.

[S.l.] : National Library of Medicine

MEDLINE is an index to journal articles in medicine, nursing, dentistry, veterinary medicine, the health care system, and the preclinical sciences, including both basic biomedical sciences and clinical practice.

Handbooks and encyclopedias

2nd ed. New York : McGraw-Hill, c2009.
Engineering » Stacks » R856.15 .S73 2009 V.1
2nd ed. Boca Raton, FL : CRC Press, c2009.
Engineering » Stacks » R856 .K53 2009
Hoboken, NJ : Wiley-Interscience, c2008.
Engineering » Stacks » R856.6 .E44 2008
New York : Marcel Dekker, c1998.
SAL3 » Stacks » R856.6 .F748 1998
Boca Raton : Taylor & Francis, 2006.
Engineering » Stacks » R856.15 .M43 2006
Boca Raton : CRC Press/Taylor & Francis, c2012.
Engineering » Stacks » R856.15 .A28 2012
2nd ed. Boca Raton : CRC/Taylor & Francis, 2006.
Engineering » Stacks » R856.6 .F749 2006
3rd ed. New York : Informa Healthcare, c2008.
Engineering » Stacks » R857 .M3 G33 2008

Materials and standards

Materials Park, Ohio : ASM International ; Cambridge, United Kingdom : Granta

A comprehensive and authoritative set of mechanical, physical, biological response, and drug compatibility properties for the materials and coatings used in medical devices.

West Conshohocken, PA : ASTM international

Full-text access to the 12,000+ ASTM standards collection including: Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices; Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials; and Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices .

Full text medical device standards from various organizations: ANSI (ISO and IEC), ASTM, AAMI , DIN, Federal Register, Code of Federal Regulations, EU Directives

[Piscataway, N.J.?] : IEEE, c1998-

Full text access to IEEE and IEE standards. Also includes access to IEEE draft standards. Including: IEEE Standard for Medical Device Communications--Overview and Framework; Health informatics – Point of Care medical device communication; American national standard for limits and methods of measurement of radio disturbance characteristics of industrial, scientific, and medical (ISM) radio-frequency equipment; and American National Standard recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio-frequency transmitters