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Standards and Guidance Documents Impacted by the Laboratory of Electrical Engineering

  • IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests, Edition 1 (1993), Edition 2 (2001), Amendment 1 (Edition 2.1, 2004), and Edition 3 (2007) (Edition 4 is in progress)
  • AAMI Technical Information (TIR) Report 18 (1997) and (2010), Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers—Part 1: Radiated radio-frequency electromagnetic energy
  • C63.18 (1997), Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio- Frequency Transmitters (Edition 2 is in progress)
  • FDA Performance Standard for Electrode Lead Wires and Patient Cables
  • Wireless Medical Telemetry Risks and Recommendations (http://www.fda.gov/cdrh/comp/guidance/1173.html)
  • Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA (http://www.fda.gov/cdrh/ode/guidance/1178.html)
  • Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073393.htm)
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072067.htm)
  • Draft Guidance for Industry and FDA Staff - Radio-Frequency Wireless Technology in Medical Devices (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077272.pdf)
  • ISO 9919, ISO/IEC 60601-2-61 Safety And Essential Performance Of Pulse Oximeters
  • Draft Guidance for Industry and FDA Staff – Class II special controls guidance document: Pulse Oximeters
  • AAMI Blood Pressure Cuff Committee
  • IEC Technical Committee 62, Electrical equipment in medical practice
  • IEC Subcommittee 62A, Common aspects of electrical equipment used in medical practice
  • IEEE Product Safety Engineering Society: Medical Device Subcommittee
  • IEC 60601-1-10, Closed Loop Physiologic Controllers
  • ASTM F29.21 – Device in the Integrated Clinical Environment committee – produced: ASTM F2761: Medical Devices and Medical Systems – Essential safety requirements for equipment comprising the patient-centric environment (ICE) – Part 1: General requirements and conceptional model.
  • ISO Technical Committee 121/SC3, Anastasia and respiratory equipment