BS EN 13976-2:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Rescue systems. Transportation of incubators System requirements
Hardcopy , PDF
29-01-2020
English
30-06-2011
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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.
| Committee |
CH/239
|
| DevelopmentNote |
Supersedes 00/565178 DC (01/2004)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
This European Standard specifies the requirements for a transport incubator system needed for care and treatment of infants, used in emergency or planned transport. It specifies the particular requirements needed to ensure the proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, extra corporeal lung support- (ECLS-) systems, gas supply) and to provide safe transportation for infants and operators. This European Standard also stipulates that the equipment or systems shall not interfere with the functions of the ambulance providing transportation. This European Standard does not give requirements for the vehicles, crafts, devices or incubators as such, these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a transport incubator system.
| Standards | Relationship |
| NBN EN 13976-2 : 2011 | Identical |
| NS EN 13976-2 : 2011 | Identical |
| NF EN 13976-2 : 2004 | Identical |
| UNE-EN 13976-2:2011 | Identical |
| ONORM EN 13976-2 : 2011 | Identical |
| EN 13976-2:2011 | Identical |
| DIN EN 13976-2:2016-03 (Draft) | Identical |
| NEN EN 13976-2 : 2011 | Identical |
| SN EN 13976-2 : 2011 | Identical |
| I.S. EN 13976-2:2011 | Identical |
| UNI EN 13976-2 : 2011 | Identical |
| DIN EN 13976-2:2011-08 | 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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