BS EN IEC 80601-2-78:2020 - Medical electrical equipment. Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

BS EN IEC 80601-2-78:2020

Medical electrical equipment. Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Status : Current   Published : April 2020

Format
PDF

Format
HARDCOPY



IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.


IEC 80601-2-78:2019 does not apply to


• external limb prosthetic devices (use ISO 22523),


• electric wheelchairs (use ISO 7176 (all parts)),


• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and


• personal care ROBOTS (use ISO 13482).




Standard NumberBS EN IEC 80601-2-78:2020
TitleMedical electrical equipment. Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
StatusCurrent
Publication Date06 April 2020
Normative References(Required to achieve compliance to this standard)IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-1-10:2007, EN 62366-1:2015/AC:2015, IEC 60601-1-11:2015, EN 60601-1-10:2008, ISO 22523:2006, ISO 14971:2007, EN 62366-1:2015, IEC 60601-1-8:2006, IEC 62366-1:2015, EN 60601-1-6:2010, EN 60601-1-2:2015
Informative References(Provided for Information)EN 60601-2-33, ISO 10535:2006, IEC 61924-2:2012, IEC TR 62366-2:2016, EN 60601-1-9:2008, IEC 60601-1-2:2007, EN ISO 10535:2006, ISO 13482:2014, ISO 9999:2016, IEC TR 60601-4-1:2017, EN ISO 9999 (ISO 9999:2016) AS, EN ISO 10218-1:2011, EN ISO 13482:2014, ISO 10218-1:2011, EN ISO 11064-7:2006, ISO 11064-7:2006, EN 61924-2:2013, IEC 60601-1-9:2007, ISO 8373:2012
International RelationshipsEN IEC 80601-2-78:2020,IEC 80601-2-78:2019
DescriptorsMedical electrical equipment, Medical equipment, Safety, Performance, Rehabilitation
ICS11.040.01
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des robots médicaux dédiés à la rééducation, l'évaluation, la compensation ou l'atténuation
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen an die Sicherheit, einschließlich der wesentlichen Leistungsmerkmale von medizinischen Robotern zur Rehabilitation, Beurteilung, Kompensation oder Linderung
CommitteeCH/62/4
ISBN978 0 580 96579 1
PublisherBSI
FormatA4
DeliveryYes
Pages82
File Size2.708 MB
Price£274.00


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