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Journal of Medical Engineering & Technology Volume 24, 2000 - Issue 1
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Research Article

Good design practice for medical devices and equipment, Part I: a review of current literature

K. Alexander, P. J. Clarkson Cambridge En gineering Design Centre at the Department of Engineering, University of Cambridge, Trumpington Street, Cambridge CB2 1PZ
Pages 5-13 | Published online: 09 Jul 2009

References

  • EUROPEAN COUNCIL, 1993, Council Directive 93/ 42/ EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities, No. L 169, 12.7.93, 1–43.
  • US FooD AND DRUG ADMINISTRATION, 1996,21 CFR parts 808, 812, and 820, Medical devices; current good manufacturing process (CGMP) final rule; quality system regulation. Federal Register, Vol. 61, pp. 52602–52662.
  • EUROPEAN COMMITTEE FOR STANDARDIZATION, Quality systems —model for quality assurance in design/ development, production, installation and servicing. EN ISO 9001: 1994 (London: British Standards Institute).
  • EUROPEAN COMMITTEE FOR STANDARDIZATION, 1996, Quality systems—medical devices—particular requirements for the application of (EN) ISO 9001. EN 46001: 1996 (London: British Standards Institute).
  • RHO DES, I., CLARKS° N, P. J., and CO LVIN, B., 1994, Process development and validation: a positive approach to validation. Medical Device Technology, 5,26–30.
  • US Fo 0 D AND DRUG ADMINISTRATION, 1997, Design control guidance for medical device manufacturers (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
  • FRIES, R. C., 1997, Reliable Design of Medical Devices (New York: Marcel Dekker).
  • UK MEDICAL DEVICES AGENCY, 1998, 1997–98 Annual Report and Accounts (London: Medical Devices Agency).
  • US FO 0 D AND DRUG ADMINISTRATION, 1998, FDA1CDRH Annual Report, fiscal Year 1998 (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
  • BO OTHROYD, G., 1996, Design for manufacture and assem-bly: the Boothroyd—Dewhurst experience. Design for X: Concurrent Engineering Imperatives edited by G. Q. Huang (London: Chapman & Hall), pp. 19–40.
  • EUROPEAN COMMITTEE FOR STANDARDIZATION, 1994, Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices, EN 724: 1994 (London: British Standards Institute).
  • EUROPEAN COMMITTEE FOR STANDARDIZATION, 1997, Medical devices—risk analysis, EN 1441: 1997 (London: British Standards Institute).
  • EUROPEAN COMMITTEE FOR STANDARDIZATION, 1996, Medical electrical equipment, Part 1: general requirements for safety, 4. Collateral standard: programmable electrical medical systems. EN 60601-1-4: 1996 (London: British Standards Institute).
  • UK PHARMACEUTICAL INDUSTRY COMPUTER SYSTEMS VALIDA-TION FORUM, 1995, GAMP: Good Automated Manufacturing Practice, Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture, Second Draft (Brussels: Inter-national Society for Pharmaceutical Engineering).
  • GLOBAL HARMONIZATION TASK FORCE STUDY GROUP 3, 1999, Process Validation Guidance Draft—February 1999 (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
  • HUANG, G. Q., 1996, Design for X: Concurrent En gin eerin g Imperatives (London: Chapman & Hall).
  • BRITISH STANDARDS INSTITUTE, 1997, Guide to managing the design of manufactured products. BS 7000: Part 2: 1997 (London: British Standards Institute).
  • PL, G., and BEITZ, W., 1996, Engineering Design: A Systematic Approach, 2nd edition (London: Springer-Verlag).
  • WIKLUND, M. E., 1995, Medical Device and Equipment Design: Usability Engineering and Economics (Buffalo Grove, IL, USA: Interpharm Press).
  • US FOOD AND DRUG ADMINISTRATION, Do it by Design: an Introduction to Human Factors in Medical Devices (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
  • ALEXANDER, K., 1999, Design for validation of medical devices and equipment. PhD Thesis, Cambridge University Engineering Department, Cambridge University, UK
  • ALEXANDER, K, CLARKSO N, P. J. and B ISH 0 P, D., 1999, Design for validation of medical devices and equipment. Workbook (Cambridge, UK Cambridge University Engineering De-partment, Cambridge University).
  • WARD, J., 1998, Techniques for supporting medical device design and verification. First Year Report (Cambridge, UK Cambridge University Engineering Department, Cam-bridge University).
  • SHEFELBINE, S., CLARKSO N, P. J., and ALEXANDER, K., 1999, Requirements capture for medical devices. Workbook (Cam-bridge, UK Cambridge University Engineering Depart-ment, Cambridge University).

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