DIN EN 13976-2:2011-08
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
Available format(s)
Hardcopy , PDF
Superseded date
07-03-2021
Language(s)
English, German
Published date
01-01-2011
Important note : Users cannot be edited or removed once added to your Multi user PDF.
National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
Annex A (informative) - Ergonomics
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive
93/42/EEC on medical devices
Bibliography
Describes the requirements for a transport incubator system needed for care and treatment of infants, used in emergency or planned transport.
| DocumentType |
Standard
|
| Pages |
13
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 13976-2:2011 | Identical |
| NF EN 13976-2 : 2004 | Identical |
| NBN EN 13976-2 : 2011 | Identical |
| NEN EN 13976-2 : 2011 | Identical |
| NS EN 13976-2 : 2011 | Identical |
| I.S. EN 13976-2:2011 | Identical |
| ONORM EN 13976-2 : 2011 | Identical |
| SN EN 13976-2 : 2011 | Identical |
| UNI EN 13976-2 : 2011 | Identical |
| UNE-EN 13976-2:2011 | Identical |
| BS EN 13976-2:2011 | Identical |
| EN 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
| EN 60601-2-20:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016) |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| EN 455-1:2000 | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
| EN 12342:1998+A1:2009 | Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| ISO 7376:2009 | Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation |
| EN 60601-2-24:2015 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| EN 1060-2:1995+A1:2009 | Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers |
| EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| EN ISO 7886-2:1997 | Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996) |
| EN 1618:1997 | Catheters other than intravascular catheters - Test methods for common properties |
| EN 1060-1:1995+A2:2009 | Non-invasive sphygmomanometers - Part 1: General requirements |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| EN 1782:1998+A1:2009 | Tracheal tubes and connectors |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| EN ISO 5356-1:2015 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN ISO 7376:2009 | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
| EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| IEC 60601-2-20:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators |
| RTCA DO 199 VOL II : 1988 | Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol II) |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| ISO 7886-2:1996 | Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps |
| 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 ISO 10555-3:2013 | Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013) |
| EN ISO 6009:2016 | Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) |
| 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 |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN 864 : 1996 | MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 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 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| 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 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| EN ISO 21647:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005) |
| 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 |
| ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| EN ISO 10555-5:2013 | Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013) |
| EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| RTCA DO 199 VOL I : 1988 | Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol I) |
| EN ISO 5356-2:2012 | Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012) |
| ISO 10555-3:2013 | Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
| ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| EN 455-2:2015 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| EN 1615:2000 | Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| ISO 6009:2016 | Hypodermic needles for single use Colour coding for identification |
| EN 1707:1996 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| ISO 10555-5:2013 | Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters |
| EN ISO 9919:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
| EN 1617:1997 | Sterile drainage catheters and accessory devices for single use |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
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