Product Safety – Need for Product Safety; Examples – Automotive; Airline; Biomedical; Organisations – EN / ISO / IEC / BIS; Safety Education; Voltage Faults – Surge and Ringing, Polarity Reversal; Current Fault – Short Circuit, Inrush, Reverse; Thermal – Over-temperature, Thermal Protection; Automotive and Biomedical Standards; ISO 26262
Product Security – Need for Product Security – Automotive and Biomedical Devices; Examples; ISO/IEC 80001; ISO/IEC 27032:2012; IEC 62304:2006
Product Compliance and Certification – Regulatory compliance – Product-specific; Substance Regulations (RoHS); Documentation; Labeling and Testing; Voluntary (Industry) Compliance – Industry-specific; Technical documentation; EU Declaration of Conformity; Usage Instructions; Traceability; IATF 16949:2016; ISO 9000; ISO 14000; ASPICE; GDPR; IEC 60601-1; IEC 60601-1-11:2015; Process of Certification; ISO / IEC 17065 Conformity Assessment; ISO 17011; Certifying Bodies; Standards; Marking / Certificate; Accreditation Bodies; IAF, FCC / FDA / CE / BIS
Reliability Engineering – Functional Reliability; Typical causes of poor reliability; Quality vs Relaibility; Principles of Reliability; Types and Severity of Failures; Statistical Distribution Curves of Failures; Failure Mode and Effects Analysis; Mean Time Between Failures; Fault Tree Analysis
Textbooks/ References
- National Safety Council and Product Safety Committee, Product safety management guidelines. Itasca, IL: The Council, 1997.
- S. Brobeck, A. C. Averyt, J. Gillis, and Consumer Federation of America, The product safety book: the ultimate consumer guide to product hazards. New York: Dutton, 1983.
- J. Doherty, Wireless and Mobile Device Security, 2nd ed. Jones and Bartlett Learning, 2021.
- K. C. Kapur and M. Pecht, Reliability engineering. Hoboken, NJ: Wiley, 2014.