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EN 740:1998/A1:2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
Superseded date

21-09-2007

Published date

12-01-2013

Foreword
Section 1 General
1 Scope
2 Normative references
3 Terminology and definitions
4 General requirements and general requirements for test
5 Classification
6 Identification, marking and documents
7 Power input
Section 2 Environmental conditions
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
Section 3 Protection against electrical shock hazards
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
    equalization
19 Continuous leakage current and patient auxiliary currents
20 Dielectric strength
Section 4 Protection against mechanical hazards
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
Section 5 Protection against hazards from unwanted or excessive
radiation
29 X-radiation
30 Alpha, beta, gamma, neutron radiation and other particle
    radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultra-violet radiation
35 Acoustical energy (including ultrasonic)
36 Electromagnetic compatibility
Section 6 Protection against hazards of ignition of
flammable anaesthetic mixtures
37 Locations and basic requirements
38 Marking, accompanying documents
30 Common requirements for category AP and category APG
    equipment
40 Requirements and tests for category AP equipment, parts
    and components thereof
41 Requirements and tests for category APG equipment, parts
    and components thereof
Section 7 Protection against excessive temperatures, and other
safety hazards
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
Section 8 Accuracy of operating data and protection against
hazardous output
50 Accuracy of operating data
51 Protection against hazardous output
Section 9 Abnormal condition and fault conditions
environmental tests
52 Abnormal operation and fault conditions
53 Environmental tests
Section 10 Constructional requirements
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - terminals and connections
59 Construction and layout
Section 11 Additional requirements specific to anaesthetic
workstations
101 Gas supply pressure monitors
102 Pressure regulators
103 Machine gas piping
104 Anaesthetic gas delivery module
105 Anaesthetic vapour delivery module
106 Respiratory gas conducting components
107 Anaesthetic breathing systems
108 Heat and moisture exchangers
109 Humidifiers
110 Suction equipment
111 Anaesthetic gas scavenging system (AGSS)
112 Anaesthetic ventilator module
Annexes
AA (normative) Test of anaesthetic agents for non-flammability
BB (informative) Rationale
CC (normative) Applicable requirement clauses for separate
    modules of an anaesthetic work station
DD (normative) Test method for expired volume monitors
EE (normative) Test method for accuracy of anaesthetic
    vapour delivery modules without applied back pressure
FF (normative) Test method for anaesthetic vapour delivery
   module accuracy with applied back pressure
GG (normative) Test methods for anaesthetic breathing systems
   and breathing attachments
HH (normative) Colour coding of anaesthetic vapour delivery
   modules
JJ (normative) Test method for resistance to flow of the
   receiving system
KK (normative) Test method for flow and resistance of AGSS
LL (normative) Test method for transfer systems
MM (normative) Test method for induced flow and
   sub-atmospheric pressure of AGSS
NN (normative) Test method for spillage from the transfer and
   receiving systems
PP (informative) Guidelines for situations in which AGSS
   are used with flammable anaesthetic gases and/or volatile
   agents
QQ (normative) Ergonomics and symbols
RR (normative) Test method for draw-over vaporizers used
   with emergency anaesthetic equipment
SS (informative) Bibliography
TT (normative) Special national conditions
ZA (informative) Clauses of this European Standard addressing
   essential requirements or other provisions of EU Directives

Gives particular requirements for modules, which, although considered as individual devices, may be used, together with other relevant devices, for the formation of an anaesthetic workstation to a given specification.

Committee
TC 215
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

I.S. EN 1280-1:1998 AGENT SPECIFIC FILLING SYSTEMS FOR ANAESTHETIC VAPORIZERS - PART 1: RECTANGULAR KEYED FILLING SYSTEMS
05/30129368 DC : DRAFT AUG 2005 ISO 9170-2 - TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
EN 1280-1:1997/A1:2000 AGENT SPECIFIC FILLING SYSTEMS FOR ANAESTHETIC VAPORIZERS - PART 1: RECTANGULAR KEYED FILLING SYSTEMS
CSA Z9170.2 : 0 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
05/30128373 DC : DRAFT JAN 2005 ISO 7396-2 - MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
CSA Z7396.2 : 2002 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
UNI EN ISO 7396-2 : 2007 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 7396-2:2007 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN 737-2:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
I.S. EN 737-2:1998 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
DIN EN ISO 7396-2:2007-07 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
BS EN ISO 7396-2:2007 Medical gas pipeline systems Anaesthetic gas scavenging disposal systems
BS EN 1280-1:1997 Agent specific filling systems for anaesthetic vaporizers Rectangular keyed filling systems
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems

EN 60601-2-26:2015 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 60601-2-10:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators
EN 60601-2-34:2014 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
EN 850:1996/A1:2000 TRANSPORTABLE GAS CYLINDERS - PIN-INDEX, YOKE-TYPE VALVE OUTLET CONNECTIONS FOR MEDICAL USE
EN 865 : 1997 PULSE OXIMETERS - PARTICULAR REQUIREMENTS
EN 1060-2:1995+A1:2009 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: General requirements
EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
ISO 2882:1979 Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits
EN 475 : 1995 MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS
EN 60601-2-25:2015 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified)
EN ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
EN 1281-2 : 1995 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS
EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 60601-2-27:2014 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
EN 864 : 1996 MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
IEC 60079-3:1990 Electrical apparatus for explosive gas atmospheres - Part 3: Spark-test apparatus for intrinsically-safe circuits
EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
EN ISO 3746:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
EN 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
EN 737-4 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
ISO 9360:1992 Anaesthetic and respiratory equipment — Heat and moisture exchangers for use in humidifying respired gases in humans
EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
EN ISO 11196 : 1997 ANAESTHETIC GAS MONITORS
EN 1280-1:1997/A1:2000 AGENT SPECIFIC FILLING SYSTEMS FOR ANAESTHETIC VAPORIZERS - PART 1: RECTANGULAR KEYED FILLING SYSTEMS
EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
EN ISO 10079-3:2014 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
EN 980:2008 Symbols for use in the labelling of medical devices
EN 60801-2 : 1993 ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991)
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

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