EN 60601-2-13 : 2006 AMD 1 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
12-01-2012
01-12-2013
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM
UNWANTED OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE
TEMPERATURES AND OTHER SAFETY HAZARDS
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress
of liquids, cleaning, sterilization and disinfection
49 Interruption of the POWER SUPPLY
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
56 Components and general assembly
57 MAINS PARTS, components and layout
SECTION 101 - ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS
DELIVERY SYSTEMS
101 Medical gas supply
102 Medical gas pipeline inlet connections
103 Medical gas supply pressure monitoring
104 Medical gas supply PRESSURE REGULATORs
105 Anaesthetic gas delivery system piping
106 Gas flow metering
107 Gas mixer
108 Oxygen flush
109 Fresh gas outlet
110 Checklist
Annex AA (informative) - Guidance and rationale for
particular clauses and subclauses in this
particular standard
Annex BB (informative) - MONITORING DEVICES, ALARM
SYSTEM(S) and PROTECTION DEVICES
Annex CC (informative) - Separate devices of an ANAESTHETIC
SYSTEM
Annex DD (normative) - Test for flammability of anaesthetic
agent
Annex EE (informative) - Clauses of this International
Standard Addressing the essential requirements
or other provisions of EU directives
Annex ZA (normative) - Normative references to international
publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
Bibliography
Index of defined terms
Specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM as well as individual devices designed for use in an ANAESTHETIC SYSTEM.
| Committee |
TC 62
|
| DevelopmentNote |
Together with EN ISO 8835-2, EN ISO 8835-3, EN ISO 8835-4 and EN ISO 8835-5 supersedes EN 740. (12/2007)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| IEC 60601-2-13:2003+AMD1:2006 CSV | Identical |
| NBN EN 60601-2-13 : 2007 AMD 1 2007 | Identical |
| NEN EN IEC 60601-2-13 : 2006 AMD 1 2007 | Identical |
| I.S. EN 60601-2-13:2006 | Identical |
| PN EN 60601-2-13 : 2006 AMD 1 2007 | Identical |
| SN EN 60601-2-13 : 2006 | Identical |
| DIN EN 60601-2-13 : 2007 | Identical |
| VDE 0750-2-13 : 2013 | Identical |
| BS EN 60601-2-13:2006 | Identical |
| UNE-EN 60601-2-13:2007 | Identical |
| CEI EN 60601-2-13 : 2007 | Identical |
| NF EN 60601 2-13 : 2007 AMD 1 2007 | Identical |
| ISO 8835-3:2007 | Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems |
| ISO 9703-1:1992 | Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 9703-3:1998 | Anaesthesia and respiratory care alarm signals Part 3: Guidance on application of alarms |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| ISO 9918:1993 | Capnometers for use with humans Requirements |
| ISO 5145:2014 | Cylinder valve outlets for gases and gas mixtures Selection and dimensioning |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
| 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 |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| ISO 5362:2006 | Anaesthetic reservoir bags |
| IEC 60079-11:2011 | Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i" |
| 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 10524:1995 | Pressure regulators and pressure regulators with flow-metering devices for medical gas systems |
| ISO 407:2004 | Small medical gas cylinders Pin-index yoke-type valve connections |
| ISO 9170-1:2017 | Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO 8835-2:2007 | Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
| ISO 9703-2:1994 | Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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