UNE-EN IEC 60601-2-31:2020
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Endorsed by Asociación Española de Normalización in May of 2020.)
Hardcopy , PDF
English
01-05-2020
Replacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNALPACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to asME EQUIPMENT.This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS asdefined in 201.3.106.HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of thisstandard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of thegeneral standard.NOTE See also 4.2 of the general standard.This standard does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES coveredby ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be connecteddirectly or indirectly to a SUPPLY MAINS.This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT andantitachycardia ME EQUIPMENT.
| Committee |
CTN 209/SC 62
|
| DocumentType |
Standard
|
| Pages |
63
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN IEC 60601-2-31:2020 | Identical |
| IEC 60601-2-31:2020 | Identical |
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