HTM Relevant Standards

  • Blood/gas exchange device committee
    Scope: Extracorporeal circulation equipment; Extracorporeal perfusion systems; Extracorporeal membrane oxygenation; Cardiopulmonary bypass systems.
  • Blood Pressure Monitoring Committee
    Scope: Provides feedback and adopts IEC 60601-2-34 on invasive blood pressure monitoring equipment. The IEC standard on this topic will be circulated for comments next year and the U.S. feedback will be needed. If any HTM professionals work with these monitors, it would be helpful to receive that feedback.
  • ECG
    Scope: Responsible for all of the ECG related standards. The IEC group is working on consolidating several standards on electrocardiographs into one mega standard. This would include adding diagnostic and cardiac monitors as well as ambulatory monitors, and possibly adding in requirements for ECG electrodes, cables and wires, and arrhythmia monitoring.
  • Electrical Safety
    Scope: Develops comments and is the consensus body which adopts IC 60601-1 standard. As such, this is an important group that works on the general requirements and need HTM participation from anyone that is interested in electrical medical equipment.
  • Infusion Device Committee
    Scope: Covers electric infusion pumps, including LVPs, enteral, etc.
  • Medical Equipment Management Committee
    Scope: Develops standards on aspects of medical equipment management for healthcare technology managers.
  • Multi-parameter Patient Monitoring Equipment Committee
    Scope: Covers patient monitors that incorporate multiple parameters such as SPO2 levels, BP, respiration etc.
  • Renal disease and detoxification committee
    Scope: Extracorporeal systems for blood purification; Guidance for the preparation and quality management of fluids for hemodialysis and related therapies; Dialysis equipment; Water testing methodologies; Dialysis fluid chemical composition.
  • Sustainability committee
    Scope: Sustainability considerations during the product design, supply chain, manufacturing, acquisition, use, and end of life of medical devices, taking into account the life cycle impacts of the product; Environmental preferable purchasing policy.

 

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