BS EN ISO 80601-2-61:2019 - Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment

BS EN ISO 80601-2-61:2019

Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment

Status : Current   Published : February 2019

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Standard NumberBS EN ISO 80601-2-61:2019
TitleMedical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment
StatusCurrent
Publication Date04 February 2019
Normative References(Required to achieve compliance to this standard)ISO 14937:2009, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-12:2014, IEC 60068-2-31:2008, ISO 4135:2001, IEC 60601-1-8:2006, IEC 60601-1:2005, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2015, IEC 60068-2-27:2008+AMD1:2013, IEC 60529:2013, ISO 7010, ISO 7000, IEC 60417, IEC 60825-2:2004, IEC 60825-2:2004/AMD1:2006, IEC 60825-1:2014, ISO 15223-1:2016, IEC 60825-2:2004/AMD2:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-2:2014, ISO 3744:2010, IEC 60068-2-64:2008, IEC 60601-1-6:2010, ISO 14155:2011, IEC 62366-1:2015, IEC 60068-2-27:2008
Informative References(Provided for Information)IEC TR 60721-4-7:2001, IEC 62366:2007/AMD1:2014, ISO/IEC Guide 99:2007, IEC 60601-1-3:2008, ISO 9000:2015, ISO 3534-2:2006, IEC 62366:2007, ASTM E456 - 13AE3, ISO 13732-1:2006, ISO 16142-1:2016, IEC 60601-1-10:2007, IEC 60601-1-3:2008/AMD1:2013, IEC TR 60878:2015, IEC TR 60721-4-7:2001/AMD1:2003, ISO 80601-2-61:2011, IEC Guide 98-3:2008, VIM, NCCLS H1-A3:2000, ISO 11073-10404:2010, GUM:1995, CLSI C46-A2:2009, ASTM F2761-14, IEC 60721-3-7:2002
ReplacesBS EN ISO 80601-2-61:2011
International RelationshipsEN ISO 80601-2-61:2019,ISO 80601-2-61:2017
Amended ByCorrigendum, March 2019
DescriptorsPerformance testing, Calibration, Medical breathing apparatus, Medical equipment, Performance, Oximeters, Haemoglobin, Oxygen, Probes (medical instruments), Chemical analysis and testing, Equipment safety, Haematology, Anaesthetic equipment, Electrical medical equipment, Clinical investigation instruments, Electrical safety
ICS11.040.10
11.040.55
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten
CommitteeCH/121/9
ISBN978 0 539 04309 9
PublisherBSI
FormatA4
DeliveryYes
Pages102
File Size2.133 MB
Price£292.00


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