DIN EN 13718-1:2014-12
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
Available format(s)
Hardcopy , PDF
Superseded date
28-10-2020
Superseded by
Language(s)
English, German
Published date
01-12-2014
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National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for medical devices for air ambulances
5 Test methods
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on Medical Devices
Bibliography
This standard is included in DIN Handbook 257.
| Committee |
TC 239
|
| DevelopmentNote |
Together with DIN EN 13718-2 and DIN 13230-10; supersedes DIN 13230-1, -2, -3, -4 and -5. (05/2003) DRAFT AMD 1 issued in April 2018. (04/2018)
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNI EN 13718-1 : 2014 | Identical |
| NS EN 13718-1 : 2014 | Identical |
| EN 13718-1:2014 | Identical |
| NF EN 13718-1 : 2017 | Identical |
| SN EN 13718-1 : 2014 | Identical |
| NBN EN 13718-1 : 2014 | Identical |
| UNE-EN 13718-1:2009 | Identical |
| I.S. EN 13718-1:2014 | Identical |
| BS EN 13718-1:2014 | Identical |
| NEN EN 13718-1 : 2014 | Identical |
| ONORM EN 13718-1 : 2014 | Identical |
| EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| EN ISO 407:2004 | Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004) |
| MIL-STD-704 Revision F:2004 | AIRCRAFT ELECTRIC POWER CHARACTERISTICS |
| EN 1865-1:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
| ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| ISO 7637-1:2015 | Road vehicles — Electrical disturbances from conduction and coupling — Part 1: Definitions and general considerations |
| MIL-DTL-26482 Revision H:2007 | Connectors, Electrical, Circular, Miniature, Quick Disconnect, Environment Resisting, Receptacles and Plugs, General Specification for |
| MIL-STD-810 Revision G:2008 | ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| ISO 10524-4:2008 | Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
| ISO 7637-2:2011 | Road vehicles Electrical disturbances from conduction and coupling Part 2: Electrical transient conduction along supply lines only |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 1005-2:2003+A1:2008 | Safety of machinery - Human physical performance - Part 2: Manual handling of machinery and component parts of machinery |
| EN 1865-4:2012 | Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
| ISO 9170-2:2008 | Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems |
| ISO 19054:2005 | Rail systems for supporting medical equipment |
| EN 60068-2-64:2008 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| EN 1865-2:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| IEC 61000-4-4:2012 RLV | Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| EN ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
| EN 61000-4-2:2009 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| RTCA DO 199 VOL II : 1988 | Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol II) |
| IEC 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| ISO 7396-2:2007 | Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| IEC 61000-4-6:2013 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
| EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| ISO 10297:2014 | Gas cylinders — Cylinder valves — Specification and type testing |
| 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 |
| ISO 10524-3:2005 | Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
| ISO 11197:2016 | Medical supply units |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| MIL-STD-461 Revision G:2015 | REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| RTCA DO 199 VOL I : 1988 | Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol I) |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| EN 1865-3:2012+A1:2015 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN 60068-2-29:1993 | Environmental testing - Part 2: Tests - Test Eb and guidance: Bump |
| ISO 407:2004 | Small medical gas cylinders Pin-index yoke-type valve connections |
| EN 60068-2-6:2008 | Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) |
| EN ISO 9170-2:2008 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| EN 61000-4-4:2012 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012) |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| IEC 60068-2-29:1987 | Environmental testing. Part 2: Tests. Test Eb and guidance: Bump |
| EN ISO 7396-2:2007 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
| EN 61000-4-6:2014/AC:2015 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| EN ISO 10524-2:2006 | Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
| EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| EN ISO 10524-1:2006 | Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 60309-2:1999/A2:2012 | PLUGS, SOCKET-OUTLETS AND COUPLERS FOR INDUSTRIAL PURPOSES - PART 2: DIMENSIONAL INTERCHANGEABILITY REQUIREMENTS FOR PIN AND CONTACT-TUBE ACCESSORIES (IEC 60309-2:1999/A2:2012) |
| IEC 60309-2:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 2: Dimensional interchangeability requirements for pin and contact-tube accessories |
| EN 1865-5:2012 | Patient handling equipment used in road ambulances - Part 5: Stretcher support |
| ISO 10524-2:2005 | Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators |
| EN 60068-2-31:2008 | ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS |
| EN 60309-1:1999/A1:2007/AC:2014 | PLUGS, SOCKET-OUTLETS AND COUPLERS FOR INDUSTRIAL PURPOSES - PART 1: GENERAL REQUIREMENTS (IEC 60309-1:1999/A2:2012) |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
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