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About This Item
Full Description
This standard applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.
This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).
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 of the general standard.
Cross References:
IEC 60601-1-2:2007
EN 60601-1-2:2007
EN 60601-1-2:2007+corrigendum Mar.:2010
IEC 60601-1-8:2006
EN 60601-1-8:2007
EN 60601-1-8:2007+corrigendum Mar.:2010
IEC 60601-2-49:2011
EN 60601-2-49:2015
Replaces BS EN 60601-2-23:2000 which remains current
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN 60601-2-23:2015
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Medical electrical equipment-Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment- Most Recent
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BS EN 60601-2-23:2000
Medical electrical equipment-Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment- Historical Version
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BS EN 60601-3-1:1997
Medical electrical equipment. Particular requirements for performance-Specification for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment- Historical Version
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BS EN 60601-2-23:1998
Medical electrical equipment-Particular requirements for the safety of transcutaneous partial pressure monitoring equipment- Historical Version