Inspections, Compliance, Enforcement, and Criminal Investigations

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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC

COMPATIBILITY ASPECTS OF MEDICAL DEVICE

QUALITY SYSTEMS


APPENDIX B - EXAMPLES OF EMC STANDARDS

AAMI (FDA/HFK-76-38), Pacemaker Standard (draft), 1975. This standard, which was never finalized, included some EMC requirements. It is currently being revised.

CISPR 11, Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment, 1990.

CISPR 14, Limits and Methods of Measurement of Radio Interference Characteristics of Household Electrical Appliances, Portable Tools and Similar Electrical Apparatus, 1985.

CISPR 16, CISPR Specification for Radio Interference Measuring Apparatus and Measurement Methods, 1987.

CISPR 22, Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Information Technology Equipment (ITE), 1985.

IEC 60601-1-2, Medical Electrical Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic Compatibility -Requirements and Tests, 1993. This standard sets limits based on the IEC 801 and 1000 series standards and the CISPR 11, 14, 16 and 22 standards.

IEC 801-x, Electromagnetic Compatibility for Industrial-Process Measurement and Control Equipment. This series of standards has been superseded by the IEC 61000-4-x series, which is referenced in more recent product family and generic EMC standards.

IEC 801-1, General Introduction, 1984.
IEC 801-2, Electrostatic Discharge Requirements, 1991.
IEC 801-3, Radiated Electromagnetic Field Requirements, 1984.
IEC 801-4, Electrical Fast Transient/Burst Requirements, 1988.

IEC 60878, Graphical symbols for electrical equipment in medical practice, 1988.

IEC 61000-4-x, Electromagnetic Compatibility (EMC) Part 4: Testing and Measurement Techniques

IEC 61000-4-1, Overview of Immunity Tests, 1992.
IEC 61000-4-2, Electrostatic Discharge Immunity Test, 1995.
IEC 61000-4-3, Radiated, RF, EMF Electromagnetic Fields Immunity Test, 1995.
IEC 61000-4-4, Electrical Fast Transient/Burst Immunity Test, 1995.
IEC 61000-4-5, Surge Immunity Test, 1995.
IEC 61000-4-6, Immunity to Conducted Disturbances, Induced by RF, 1995.
IEC 61000-4-7, Harmonics and Interharmonics Measurements and Instrumentation for Power Supply Systems, 1991.
IEC 61000-4-8, Power Frequency Magnetic Field Immunity Test, 1993.
IEC 61000-4-9, Pulse Magnetic Field Immunity Test, 1993.
IEC 61000-4-10, Damped Oscillatory Magnetic Field Immunity Test, 1993.
IEC 61000-4-11, Voltage Dips, Short Interruptions, and Voltage Variations Immunity Test, 1995.
IEC 61000-4-12, Oscillatory Waves Immunity Test, 1995.

IEC 61326-1, EMC Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use (draft),.1997.

MIL-STD-461D, Requirements for the Controls of Electromagnetic Interference Emissions and Susceptibility, January 11, 1993.

MIL-STD-462D, Measurements of Electromagnetic Interference Characteristics, January 11, 1993.

MIL-STD-463A, Definitions and System of Units, Electromagnetic Interference and Electromagnetic Compatibility Technology, June 1, 1977.

MDS-201-0004, Electromagnetic Compatibility Standard for Medical Devices, October 1, 1979. This standard was developed under contract from FDA by McDonnell Douglas, but was not adopted as mandatory; it is considered a voluntary guideline.

UL 2601-1, Medical Electrical Equipment, December 1993. This standard includes the text of the IEC 60601-1 standard with U.S. national deviations for such things as wire coding. A UL mark for conformance with this standard, however, does NOT cover EMC unless the certification paper specifically so states.

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