BS 5724-2.204(1999) : 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
07-06-2004
BS EN ISO 8835-2:2009
BS EN ISO 8835-4:2009
BS EN ISO 8835-5:2009
BS EN 60601-2-13:2006
23-11-2012
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 formation of an anaesthetic workstation to a given specification.
Committee |
CH/121/1
|
DevelopmentNote |
Also numbered as BS EN 740. (10/1999) Supersedes BS 5724-2.13(1990). Together with BS EN 737-2, BS EN 737-4 & BS EN 740 supersedes BS 6834(1987) Supersedes 92/57250 DC. (08/2004)
|
DocumentType |
Standard
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
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 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) |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 2882:1979 | Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits |
EN 475 : 1995 | MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS |
IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
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 |
IEC 60601-2-30:1999 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
EN 1281-2 : 1995 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS |
EN 737-2:1998/A1:1999 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
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 |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
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 |
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 |
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) |
ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
NFPA 53M : 1990 | FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES |
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 |
IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
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 |
ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
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) |
IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
EN 980:2008 | Symbols for use in the labelling of medical devices |
IEC 60801-2:1991 | Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.