UNE-EN ISO 80601-2-13:2013
Current
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
31-07-2013
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CTN 110
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| DevelopmentNote |
Supersedes UNE EN 60601-2-13, UNE EN ISO 8835-2, UNE EN ISO 8835-3, UNE EN ISO 8835-4 & UNE EN ISO 8835-5. (02/2016) NEW CHILD AMD 2 2020 IS NOW ADDED NEW CHILD AMD 1 2020 IS NOW ADDED
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| DocumentType |
Standard
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| Pages |
116
|
| ProductNote |
NEW CHILD AMD 2 2020 IS NOW ADDED
NEW CHILD AMD 1 2020 IS NOW ADDED |
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-13:2011 | Identical |
| EN ISO 80601-2-13:2012 | Identical |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ISO 5360:2016 | Anaesthetic vaporizers Agent-specific filling systems |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC TR 60083:2015 | Plugs and socket-outlets for domestic and similar general use standardized in member countries of IEC |
| 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 |
| BS 4272-3:1989 | Anaesthetic and analgesic machines Specification for continuous flow anaesthetic machines |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 9170-2:2008 | Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| ISO 8835-7:2011 | Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| IEC 60079-20-1:2010 | Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| ISO 7396-2:2007 | Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems |
| 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 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| 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 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 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| 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 |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
| ISO 80601-2-55:2011 | Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 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 |
| ISO 5358:1992 | Anaesthetic machines for use with humans |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 9170-1:2017 | Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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