UNE-EN ISO 80601-2-13:2013

Superseded

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

UNE-EN ISO 80601-2-13:2013/A1:2020

Available format(s)

Hardcopy , PDF

Superseded date

02-22-2023

Language(s)

Spanish, Castilian, English

Published date

07-31-2013

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 110
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
DocumentType	Standard
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Status	Superseded
SupersededBy	UNE-EN ISO 80601-2-13:2023
Supersedes	UNE-EN ISO 80601-2-13:2023 UNE-EN ISO 8835-3:2009 UNE-EN 60601-2-13:2007 UNE-EN ISO 8835-4:2009 UNE-EN ISO 8835-3:2009/A1:2011 UNE-EN ISO 8835-2:2009 UNE-EN 60601-2-13:2007/A1:2007 UNE-EN ISO 8835-5:2009

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