IEC 60601-2-13:2003+AMD1:2006 CSV
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
08-11-2011
English
08-31-2009
FOREWORD
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
Bibliography
Index of defined terms
IEC 60601-2-13:2003+A1:2006(E) specifies particular safety and essential performance requirements for individual devices designed for use in an anaesthetic system as well as specific requirements for the anaesthetic gas delivery system. This standard specifies requirements and defines interfaces for:
- individual devices designed for use in an anaesthetic systems(s), and
- integrated anaesthetic systems.
This consolidated version consists of the third edition (2003) and its amendment 1 (2006). Therefore, no need to order amendment inaddition to this publication.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2014. (10/2012)
|
| DocumentType |
Standard
|
| Pages |
45
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN VDE 0750-214 : 1992 | Identical |
| GOST IEC 60601-2-13 : 2011 | Identical |
| NEN EN IEC 60601-2-13 : 2006 AMD 1 2007 | Identical |
| NEN IEC 60601-2-13 : 2004 AMD 1 2006 | Identical |
| I.S. EN 60601-2-13:2006 | Identical |
| PN EN 60601-2-13 : 2006 AMD 1 2007 | Identical |
| SANS 60601-2-13 : 1.01ED 2010 | Identical |
| SN EN 60601-2-13 : 2006 | Identical |
| AS/NZS 3200.2.13:2005 | Identical |
| DIN EN 60601-2-13 : 2007 | Identical |
| VDE 0750-2-13 : 2013 | Identical |
| VDE 0750-214 : 1992 | Identical |
| UNE 20613-2-13:1993 | Identical |
| BS EN 60601-2-13:2006 | Identical |
| UNE-EN 60601-2-13:2007 | Identical |
| CEI EN 60601-2-13 : 2007 | Identical |
| EN 60601-2-13 : 2006 AMD 1 2007 | Identical |
| NF EN 60601 2-13 : 2007 AMD 1 2007 | Identical |
| DIN VDE 0750-214 : 1992 | Corresponds |
| CSA C22.2 No. 60601.2.13 :2007 | Identical |
| CSA C22.2 No. 60601.2.13 : 2007 : R2012 | Identical |
| CSA Z8835.3 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| I.S. EN 740:1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| DD ISO/TS 18835:2004 | Inhalational anaesthesia systems. Draw-over vaporizers and associated equipment |
| I.S. EN ISO 8835-4:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| DIN EN ISO 8835-3:2011-02 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| I.S. EN 14522:2005 | DETERMINATION OF THE AUTO IGNITION TEMPERATURE OF GASES AND VAPOURS |
| CSA C22.2 No. 60601.2.12 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| ISO/TS 18835:2004 | Inhalational anaesthesia systems Draw-over vaporizers and associated equipment |
| ISO 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| I.S. ISO 5369:1987 | BREATHING MACHINES FOR MEDICAL USE - LUNG VENTILATORS |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| DIN EN ISO 8835-4:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| DIN EN ISO 8835-2:2009-08 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| BS EN ISO 8835-2:2009 | Inhalational anaesthesia systems Anaesthetic breathing systems (ISO 8835-2:2007) |
| DIN EN ISO 10651-2:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| NF EN ISO 8835-3 : 2009 AMD 1 2011 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| I.S. EN ISO 8835-2:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| 04/30099768 DC : DRAFT DEC 2004 | PREN ISO 8835-3 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: ANAESTHETIC GAS SCAVENGING SYSTEMS - TRANSFER AND RECEIVING SYSTEMS |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| CSA Z8835.2 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
| DIN EN 14522 E : 2005 | DETERMINATION OF THE AUTO IGNITION TEMPERATURE OF GASES AND VAPOURS |
| ISO 8835-2:2007 | Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
| ISO 8835-3:2007 | Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| CSA Z8835.4 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| UNI EN ISO 10651-2 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS |
| UNI EN ISO 8835-5 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| UNI EN ISO 8835-4 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| UNI EN ISO 8835-2 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
| UNI EN ISO 8835-3 : 2010 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 01/561640 DC : DRAFT APR 2001 | BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| CSA Z10651.2: 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| CSA ISO TS 18835 : 2014 | INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| DIN EN ISO 8835-5:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| BS EN 14522:2005 | Determination of the auto ignition temperature of gases and vapours |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| BS EN ISO 10651-2:2004 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| ISO 8835-4:2004 | Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices |
| EN ISO 10651-2:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
| EN ISO 8835-4:2009 | Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
| EN ISO 8835-5:2009 | Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| EN 740:1998/A1:2004 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| EN ISO 8835-3:2009/A1:2010 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| EN 14522:2005 | Determination of the auto ignition temperature of gases and vapours |
| EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
| EN ISO 8835-2:2009 | Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
| BS EN ISO 8835-3 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| I.S. EN ISO 8835-5:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| I.S. EN ISO 10651-2:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z10651.2 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| I.S. EN ISO 8835-3:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| EN ISO 11073-10418:2014/AC:2016 | Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016) |
| BS EN ISO 8835-5:2009 | Inhalational anaesthesia systems Anaesthesia ventilators |
| BS EN ISO 8835-4:2009 | Inhalational anaesthesia systems Anaesthetic vapour delivery devices |
| DIN EN 14522:2005-12 | Determination of the auto ignition temperature of gases and vapours |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| 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 |
| 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 |
| 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 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| 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 8835-4:2004 | Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices |
| 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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