BS EN 60601-2-31:2008 PDF

Scope: Clause 1 of the general standard applies, except as follows: Replacement: 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. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of his 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.

BS EN 60601-2-31:2008 Referenced Document

ANSI/AAMI PC69-2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
ISO 14708-2:2005 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

2009 BS EN 60601-2-31:2008+A1:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
2009 BS EN 60601-2-31:2008 Medical electrical equipment - Part 2-31:Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
0000 BS EN 60601-2-31:1995