BS EN IEC 60601-2-31:2020

201.1   Scope, object and related standards Clause 1 of the general standard 1 applies, except as follows:

   201.1.1   * Scope 
   
      Replacement: 
      
   
     
     This part of [IEC 60601](/search?q=IEC%C2%A060601)
      applies to the  basic safety  and  essential performance  of   external pacemakers   powered by an  internal electrical power source , hereafter referred to as  me equipment . 
   This document applies to   patient cables   as defined in 201.3.209, but does not apply to   leads   as defined in 201.3.206. 
   
      Hazards  inherent in the intended physiological function of  me equipment  within the scope of this document are not covered by specific requirements in this
     document except in 7.2.13 and 8.4.1 of the general standard. 
   
       NOTE  See also 4.2 of the general standard. 
   
   This document does not apply to the implantable parts of   active implantable medical devices   covered by [ISO 14708‑1](/search?q=ISO%C2%A014708%E2%80%911). This document does ...