IEC 60601-2-13:2009 pdf download – Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
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.
IEC 60079-4:1975，Electrical apparatus for explosive gas atmospheres – Part 4: Method oftest for ignition temperature
IEC 60079-11:1999，Electrical apparatus for explosive gas atmospheres – Part 11: Intrinsicsafety”
Iso 32:1977,Gas cylinders for medical use – Marking for identification of content
ISO 407:1991,Small medical gas cylinders – Pin-index yoke-type valve connections
ISO 3746:1995，Acoustics – Determination of sound power levels of noise sources usingsound pressure – Survey method using an enveloping measurement surface over a reflectingplane
ISO 4135:2001, Anaesthetic and respiratory equipment – Vocabulary
2Terminology and definitions
This clause of the General Standard applies except as follows:
Addition before 2.1:
An index of defined terms used in this Particular Standard is given after the annexes.Additional definitions:
2.101.1
ALARM CONDITION
condition that occurs when a variable that is being monitored by an ALARM SYSTEM equals orfalls outside the set ALARM LIMIT(s)
2.101.2
ALARM LIMIT
value(s) which are set by the manufacturer, the device, the usER or OPERATOR,which definethe threshold range of the ALARM CONDITION
2.101.3
ALARM SIGNAL
signal, the purpose of which is to alert the oPERATOR of an abnormal condition in the PATIENTor the EQuIPMENT that may develop into a SAFETY HAZARD which requires oPERATOR awarenessor action
2.101.4
ALARM sYSTEM
system that is intended to make the oPERATOR(S) aware of an ALARM CONDITION, in the PATIENTor EQUIPMENT, by means of its ALARM SIGNAL(s)
2.101.5
ANAESTHETIC GAs DELIVERY sYSTEM
assembly of components which controls and delivers the fresh gas into the ANAESTHETICBREATHING sYSTEM
NOTE lt may include a flow control system,flow melers andor a gas mixing system and ANAESTHETIC GAS DELIVERY SYSTEMPIPING.
2.101.6
ANAESTHETIC GAS DELIVERY svSTEM PIPING
all pipework，including unions, from unidirectional valves in the pipeline inlets and from theoutiets of the PREsSURE REGULATOR(s) to the flow control system，as well as the pipingconnecting the flow control system and the piping connecting the ANAESTHETIC VAPoURDELIVERY DEVIicE to the FRESH GAs oUTLET. lt includes piping leading to and from pneumaticALARM SYSTEM(S), pressure indicators, oxygen flush and gas power outlets
