Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
|Publication Date:||1 September 2011|
|ICS Code (Medical equipment in general):||11.040.01|
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.
This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS as defined in 201.3.106.
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.
NOTE See also 4.2 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.