MSZ EN 60601-2-23:2016

Gyógyászati villamos készülékek. 2-23. rész: Transzkután parciálisnyomás-figyelő készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-23:2011)

Medical electrical equipment. Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:2011)


Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a system. 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. NOTE See also 4.2 of the General Standard. 201.1.2 Object Replacement: The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63.

Általános információk

Érvényes
angol
: 2016-06-01

11.040.55 - Diagnosztikai készülékek

MSZT/MB 843  Gyógyászati villamos készülékek

: idt EN 60601-2-23:2015; idt IEC 60601-2-23:2011


Vásárlás

: 13 170,0 Ft
(papír , PDF-fájl-letöltés)



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MSZ EN 60601-2-23:2016

2016-06-01

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