BS EN 60601-2-31:2008 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 60601-2 series of standards is being updated, in line with the 3rd Edition of the General Standard; BS EN 60601-1: 2006.
The new parts specify the minimum safety requirements to ensure the safe use of medical electrical equipment.
BS EN 60601-2-31 is the British standard applicable to the basic safety and essential performance of external pacemakers powered by an internal electrical power source, referred to as ME equipment. BS EN 60601-2-31 applies to patient cables.
BS EN 60601-2-31 does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1. BS EN 60601-2-31 does not apply to external pacemakers that can be connected directly or indirectly to a mains supply.
BS EN 60601-2-31 does not apply to transthoracic and oesophageal pacing ME equipment and antitachycardia ME equipment.
Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned.
Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.
The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of external cardiac pacemakers with an internal power source. Cardiac pacemakers treat cardiac arrhythmias. Such arrhythmias reduce cardiac output and can lead to confusion, dizziness, loss of consciousness and death. The objective of pacing is to restore cardiac rhythm and output appropriate to the patient's physiological needs.
There are two distinct families of cardiac pacemakers, implantable pacemakers and external pacemakers. External pacemakers are used to pace patients temporarily prior to implanting an implantable pacemaker as well as for temporary pacing related to other medical procedures, e.g. open heart surgery.
Cardiac pacemakers differ in the various ways in which they maintain and monitor cardiac activity in different circumstances. The simplest model stimulates the atrium or ventricle independently of the cardiac activity; others detect atrial or ventricular activity and stimulate the atrium or ventricle as and when this is necessary; others, more complex, detect the spontaneous heart activity and stimulate appropriately the atrium and/or the ventricle. Certain pacemakers work on preset frequency values, amplitudes and impulse duration. Others can have several values for parameters.
Standards for external pacemakers require attention to information that will aid in selecting and applying these devices. it is through these aspects of standardization that the central role of clinical experience should be, or has been, acknowledged. The ability to predict how a pacemaker will perform in a specific patient based on testing of a device to a set of technical criteria is limited.
This particular standard does not take into consideration the specific safety aspects of external pacemakers connected to a mains supply while simultaneously connected to the patient.
This particular standard amends and supplements BS EN 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, referred to as the general standard.
The requirements are followed by specifications for the relevant tests.
BS EN 60601-2-31 includes an Annex giving an inventory of the patient's safety posed by external pacemakers and a rationale for the safety requirements contained in this particular standard. It is considered that knowledge of the reasons for these requirements will facilitate the proper application of the standard, and also expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. The annex does not form part of the requirements of this standard.
Contents of BS EN 60601-2-31 contain:
- Scope, object and related standards
- Normative references
- Terms and definitions
- General requirements for testing ME equipment
- Classification of ME equipment and ME systems
- ME equipment identification, marking and documents
- Protection against electrical hazards from ME equipment
- Protection against mechanical hazards of ME equipment and ME systems
- Protection against unwanted and excessive radiation hazards
- Protection against excessive temperatures and other hazards
- Accuracy of controls and instruments and protection against hazardous outputs
- Hazardous situations and fault conditions
- Programmable electrical medical systems (PEMS)
- Construction of ME equipment
- ME systems
- Electromagnetic compatibility of ME equipment and ME systems
- Electromagnetic compatibility – requirements and tests
- Particular guidance and rationale
- Bibliography
- Index of defined terms used in this particular standard
