ÖVE/ÖNORM EN 60601-2-31

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.