Alcance
Replacement:This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNALPACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to asME EQUIPMENT.This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADSas defined in 201.3.206.HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope ofthis document are not covered by specific requirements in this document except in 7.2.13 and8.4.1 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 DEVICEScovered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can beconnected directly or indirectly to a SUPPLY MAINS.This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT andantitachycardia ME EQUIPMENT.