Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
|Publication Date:||1 January 2005|
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
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 or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.
NOTE 1 See also 4.2.
The IEC 60601 series does not apply to:
- in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series ;
- implantable parts of active implantable medical devices covered by the ISO 14708 series ; or
- medical gas pipeline systems covered by ISO 7396-1 .
NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.
use for which a product, PROCESS or service is intended according to the specifications, instructions and information provided by the... View More
use for which a product, PROCESS or service is intended according to the specifications, instructions and information provided by the MANUFACTURER
[ISO 14971:2007, definition 2.5]
NOTE INTENDED USE should not be confused with NORMAL USE. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, but maintenance, transport, etc. as well.View Less