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Developing Real-Time Embedded Products 94 2.17 Summary This chapter focuses on mission-critical and safety-critical devices. The development of mission-critical and safety-critical devices requires an understanding of the appropriate standards for each market and specific trade-offs that might be made in developing them. Process for missioncritical and safety-critical devices is rigorous and must be carefully planned. References 1. U.S. FDA, Design Control Guidance for Medical Device Manufacturers, March 11, 1997, relates to FDA 21 CFR 820.30 and sub-clause 4.4 of ISO9001. http://www. fda.gov/cdrh/comp/designgd.pdf. pp. i, 1, 2, 4, 5, 8, 13, 19, 23, 37, 43. 2. Software Considerations in Airborne Systems and Equipment Certification, RTCA/ DO-178B, December 1, 1992. RTCA, Inc., 1828 L Street, NW, Suite 805, Washington, D.C. 20036. pp. A-2, A-3, 1, 7, 68–77. You can purchase DO-178B at http://www.rtca.org 3. EMC Standards, Compliance Engineering, Vol. 21, No. 1, 2004 Annual Reference Guide, pp. 75–82. 4. ESD Standards, Compliance Engineering, Vol. 21, No. 1, 2004 Annual Reference Guide, pp. 103–105. 5. Telecom Standards and Regulations, Compliance Engineering, Vol. 21, No. 1, 2004 Annual Reference Guide, pp. 139–142. 6. Product Safety Standards, Compliance Engineering, Vol. 21, No. 1, 2004 Annual Reference Guide, pp. 165–172. 7. http://www.nhtsa.dot.gov/ 8. www.arb.ca.gov (California Air Resources Board). 9. US Environmental Protection Agency, Office of Transportation and Air Quality, publication EAP420-B-00-001, February 2000. 10. www.aecc.be/en/european_legislation.htm (European Association for Emissions Control). 11. Absmeier, J., Dundar, B., and Wilcutts, M., Embedded Controller Hardware and Operating System Selection for MoBIES Powertrain Testbed, Vehicle Dynamics Laboratory, University of California, Berkeley, October 31, 2003. http://vehicle. me.berkeley.edu/mobies/powertrain/reports/Controller_Hardware_and_ Operating_System.doc 12. http://store.sae.org/webcd.htm 13. Marcus, M. and Biersach, B., Regulatory Requirements for Medical Equipment, IEEE Instrumentation & Measurement Magazine, Vol. 6, No. 4, December 2003, pp. 23–29. 14. http://www.ul.com/info/standard.htm 15. http://www.ce-mark.com/cedoc.html 16. http://ts.nist.gov/Standards/Global/pg17.cfm 17. Monnich, Jr., H., ISO 9001:2000 for Small and Medium Sized Businesses, ASQ Quality Press, Milwaukee, WI, 2001. 18. Kasse, T., Practical Insight Into CMMI, Artech House, Boston, MA, 2004.
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