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CSA C22.2 NO 60601-2-23

Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

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Organization: CSA
Publication Date: 1 January 2012
Status: active
Page Count: 122
ICS Code (Diagnostic equipment): 11.040.55
scope:

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.

Document History

Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
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...
CSA C22.2 NO 60601-2-23
January 1, 2012
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
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...
Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
A description is not available for this item.
Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
This Particular Standard specifeis requirments for the safety, including essential performance, of TRANSCUTANEOUS PARTIAL PRESSURE MONITRING EQUIPMENT, as defined in 2.101 and hereinafter referred to...
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Transcutaneous Partial Pressure Monitoring Equipment
A description is not available for this item.

References

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