Medical electrical equipment - Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Medical electrical equipment - Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

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What is BS EN IEC 60601‑2‑31 about?  

BS EN IEC 60601 discusses medical electrical equipment. BS EN IEC 60601‑2‑31 outlines basic safety and essential performance of external pacemakers powered by an internal electrical power source. 

Note 1: BS EN IEC 60601‑2‑31 applies to patient cables as defined in 201.3.209 but does not apply to leads as defined in 201.3.206. 

Note 2: BS EN IEC 60601‑2‑31 does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 and to external pacemakers which can be connected directly or indirectly to supply mains. 

Who is BS EN IEC 60601‑2‑31 for? 

BS EN IEC 60601‑2‑31 on external cardiac pacemakers (with internal power source) is useful for: 

  • Manufacturers of medical electrical equipment 
  • Hospitals  
  • Healthcare regulatory authorities 
  • Test centres for medical electrical equipment  
  • Research and development teams 
  • Quality control professionals  

Why should you use BS EN IEC 60601‑2‑31? 

Cardiac pacemakers treat cardiac arrhythmias. Such arrhythmias reduce cardiac output and can lead to confusion, dizziness, loss of consciousness, and death. The objective of pacing is to restore cardiac rhythm and output appropriate to the patient's physiological needs. 

BS EN IEC 60601‑2‑31 guidelines help you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures, and other hazards for external cardiac pacemakers with an internal power source. This minimizes hazards to the patient and operator. 

What’s changed since the last update? 

BS EN IEC 60601‑2‑31:2020 supersedes IEC 60601‑2‑31:2008, which has been withdrawn. BS EN IEC 60601‑2‑31:2020 has some technical changes with respect to IEC 60601‑2‑31:2008. These include: 

  • The requirement for testing for energy reduction has been removed 
  • The test for exposure to external defibrillation has been completely revised 
  • The exclusion for testing ESD immunity only with respect to air discharges has been removed 
  • Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117 
  • Additional rationale for all changes