NEN-EN-IEC 60601-2-31
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
| Organization: | NEN |
| Publication Date: | 1 May 2020 |
| Status: | active |
| Page Count: | 122 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This part of IEC 60601 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 document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS.
This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.
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