IEC 60601-2-13:2009 pdf free download

IEC 60601-2-13:2009 pdf free download Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
1scope and object
This clause of the General Standard applies except as follows:
1.1 scope
Addition
This Particular Standard specifies safety and essential performance requirements for anANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use inan ANAESTHETIC sYSTEM.
This Particular Standard does not apply to:
ANAESTHETIC SYSTEM(s) intended for use with flammable anaesthetic agents,as
determined by Annex DD,
portable ANAESTHETIC SYSTEM(s) for use in remote sites,open fields for rescue operationsor in disaster areas,
-dental analgesia apparatus.
1.2Object
Replacement:
The object of this Particular Standard is to specify particular safety and essential performancerequirements for individual devices designed for use in an ANAESTHETIC SYSTEM as well asspecific requirements for the ANAESTHETIC GAS DELIVERY SYSTEM. This standard specifiesrequirements and defines interfaces for:
– individual devices designed for use in an ANAESTHETIC SYSTEM(s), and- integrated ANAESTHETIC SYSTEMS.
1.3Particular Standards
This Particular Standard amends and supplements a set of lEC publications consisting ofIEC 60601-1:1988,Medical electrical equipment – Part 1: General requirements for safety,its amendment 1 (1991) and amendment 2 (1995),hereinafter referred to as the “GeneralStandard”.
The General Standard takes into account lEC 60601-1-1:2000，Medical electrical equipment -Part 1-1: General requirements for safety – Collateral standard: Safety requirements formedical electrical systems and lEC 60601-1-2 2001，Medical electrical equipment – Part 1-2:General requirements for safety – Collateral standard: Electromagnetic compatibility -Requirements and tests.
The numbering of sections, clauses and subclauses of this Particular Standard correspondswith that of the General Standard. The changes to the text of the General Standard arespecified by 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 text of this Particular Standard is additional to the requirements ofthe 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” covers this Particular Standard，used together with the GeneralStandard and the Collateral Standards.
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, although possibly relevant, is notto be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard replacing or modifying requirements of theGeneral Standard or a Collateral Standard take precedence over the corresponding generalrequirement(s).
1.3.101 Related lnternational Standards
The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies.For undated references, the latest editionof the referenced document (including any amendments) applies.