This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred
to as ME EQUIPMENT.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of
this standard are not covered by specific requirements in this standard except in 7.2.13 and
8.4.1 of the general standard.
This standard does not apply to the implantable parts of
ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1 This standard does not apply to
EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS.
This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and
antitachycardia ME EQUIPMENT.
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for EXTERNAL PACEMAKERS as defined in 201.3. 103.