IEC 60601-2-34-2000 pdf free download – Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment.
1 Scope and object
This clause of the General Standard applies except as follows:*
1.1 scope
Addition:
This Particular Standard applies to lNVASIVE BLOOD PRESSURE MONITORING and measuringequipment as defined in 2.101, hereinafter referred to as EQUIPMENT.
This Particular Standard does not apply to cATHETER tubing，CATHETER needles,Luer locks,taps and tap tables.
This Particular Standard also does not apply to NON-INVASIVE BLOOD PRESSURE MONITORINGEQUIPMENT.
1.2ObjectReplacement:
The object of this Particular Standard is to establish particular requirements for the safety,including the essential performance of EQUIPMENT, as defined in 2.101.
1.3Particular Standards
Addition:
This Particular Standard refers to lEC 60601-1:1988,Medical electrical equipment – Part 1:General requirements for safety as amended by its amendment 1 (1991) and its amendment 2(1995).
The General Standard takes into account lEC 60601-1-2:1993,Medical electrical equipment -Part 1: General requirements for safety – 2. Collateral Standard: Electromagneticcompatibility – Requirements and tests and IEc 60601-1-4:1996,Medical electrical equipment- Part 1: General requirements for safety – 4.Collateral Standard: Programmable electricalmedical systems.
For brevity，IEC 60601 is referred to in this Particular Standard either as the “GeneralStandard” or as the “General Requirement(s)”.
The numbering of sections, clauses or subclauses of this Particular Standard corresponds tothat of the General Standard.The changes to the text of the General Standard are specifiedby the use of the following words:
“Replacement”means that the clause or subclause of the General Standard is replacedcompletely by the text of this Particular Standard.
“Addition”means that the clause or subclause of this Particular Standard is additional to therequirements of the General Standard.
“Amendment”means that the clause or subclause of the General Standard is amended asindicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numberedstarting from 101, additional annexes are lettered AA,BB,etc, and additional items aa), bb),etc.
The term“this Standard” is used to make reference to the General Standard and thisParticular Standard taken together.
An asterisk (*) notes clauses for which there is rationale comment in Annex AA or Annex BB.lt is considered that a knowledge of the reasons for these requirements will facilitate theproper application of the standard and be of use in any revision that may be necessitated bychanges in clinical practice or as a result of developments in technology.
Where there is no corresponding section,clause or subclause in this Particular Standard, thesection, clause or subclause of the General Standard, although possibly not relevant, applieswithout modification; where it is intended that any part of the’ General Standard，althoughpossibly relevant, is not to be applied，a statement to that effect is given in this ParticularStandard.
The requirements of this Particular Standard take priority over those of the General Standardand of the Collateral Standards mentioned above.
2Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5
APPLIED PARTReplacement:
The TRANSDUCER，including any fluid-filled system
Additional definitions:
2.101
INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (EQUIPMENT)
stand-alone measuring equipment or part of a physiological monitoring or measuring system,including associated TRANSDUCERs,that is used for the internal measurement of circulatorysystem pressures.
2.1 03
CATHETER TIP TRANSDUCER
TRANSDUCER mounted at, or close to, the tip of a catheter and intended for insertion into the cardiovascular systemIEC 60601-2-34 pdf download.