DIN EN 1789:2014-12
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - ROAD AMBULANCES
Hardcopy , PDF
12-19-2020
English, German
01-01-2014
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National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Testing
6 Medical devices
7 Conformity assessment
8 Requirements to be met for a Certificate of Compliance
Annex A (informative) - Test summary
Annex B (informative) - Definition of ambulance body styles
Annex C (informative) - Recognition
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EC
Directive 93/42/EEC on Medical Devices and
Directive 2007/46/EC of the European Parliament
and of the Council of 5 September 2007 establishing
a framework for the approval of motor vehicles and
their trailers, and of systems, components and
separate technical units intended for such vehicles
Bibliography
Defines requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients.
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM EN 1789 : 2014 | Identical |
| NS EN 1789 : 2007 + A2 2014 | Identical |
| NF EN 1789 : 2007 + A2 2014 | Identical |
| BS EN 1789 : 2007 | Identical |
| UNI EN 1789 : 2014 | Identical |
| I.S. EN 1789:2007 | Identical |
| NEN EN 1789 : 2007 + A2 2014 | Identical |
| UNE-EN 1789:2007 | Identical |
| NBN EN 1789 : 2007 + A2 2014 | Identical |
| SN EN 1789 : 2007 + A2 2014 | Identical |
| EN 1789:2007+A2:2014 | Identical |
| EN 455-1:2000 | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
| EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| EN ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
| EN ISO 407:2004 | Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004) |
| EN 14052:2012+A1:2012 | High performance industrial helmets |
| EN 1865-1:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| EN 1865-4:2012 | Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
| ISO 19054:2005 | Rail systems for supporting medical equipment |
| EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
| 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 |
| EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| EN 737-1 : 1998 | MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM |
| EN 737-3:1998/A1:1999 | MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| 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 |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| ISO 5128:1980 | Acoustics — Measurement of noise inside motor vehicles |
| 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 |
| IEC 60364-7-721:2017 | Low-voltage electrical installations - Part 7-721: Requirements for special installations or locations - Electrical installations in caravans and motor caravans |
| EN 420:2003+A1:2009 | Protective gloves - General requirements and test methods |
| ISO 11197:2016 | Medical supply units |
| EN 12470-1:2000+A1:2009 | Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device |
| ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
| EN 3-7:2004+A1:2007 | Portable fire extinguishers - Part 7: Characteristics, performance requirements and test methods |
| EN ISO 20345:2011 | Personal protective equipment - Safety footwear (ISO 20345:2011) |
| ISO 20471:2013 | High visibility clothing — Test methods and requirements |
| EN 455-2:2015 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
| ISO 80601-2-61:2011 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| ISO 80601-2-55:2011 | Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 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 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 60068-2-6:2008 | Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) |
| ISO 20345:2011 | Personal protective equipment Safety footwear |
| 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) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| 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) |
| EN 60068-2-32:1993 | Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| 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 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 1865-5:2012 | Patient handling equipment used in road ambulances - Part 5: Stretcher support |
| EN 60601-2-4:2011 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
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