|
gptkbp:instanceOf
|
gptkb:International_Standard
|
|
gptkbp:amendedBy
|
gptkb:IEC_60601-1:2005/AMD1:2012
gptkb:IEC_60601-1:2005/AMD2:2020
|
|
gptkbp:appliesTo
|
Regulatory authorities
Testing laboratories
Manufacturers of medical electrical equipment
|
|
gptkbp:basisFor
|
gptkb:IEC_60601-1-2
gptkb:IEC_60601-1-6
gptkb:IEC_60601-1-11
gptkb:IEC_60601-1-12
gptkb:IEC_60601-1-8
|
|
gptkbp:category
|
Medical device standard
|
|
gptkbp:covers
|
gptkb:EMC_(Electromagnetic_compatibility)
Radiation safety
Electrical safety
Mechanical safety
Software safety
Thermal safety
|
|
gptkbp:currentEditionYear
|
2020
|
|
gptkbp:firstPublished
|
1977
|
|
gptkbp:focusesOn
|
Medical electrical equipment
|
|
gptkbp:hasSection
|
Construction
Testing
Accuracy of controls and instruments
Hazardous situations and fault conditions
Marking and documentation
Programmable electrical medical systems
Protection against electric shock
Protection against mechanical hazards
Protection against unwanted and excessive radiation
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
IEC 60601-1
|
|
gptkbp:language
|
gptkb:French
gptkb:German
English
|
|
gptkbp:latestReleaseVersion
|
3.2
|
|
gptkbp:partOf
|
gptkb:IEC_60601_series
|
|
gptkbp:publishedBy
|
gptkb:International_Electrotechnical_Commission
|
|
gptkbp:recognizedBy
|
gptkb:IEC_60601-1
|
|
gptkbp:referencedIn
|
gptkb:FDA
gptkb:European_Union_Medical_Device_Regulation
|
|
gptkbp:replacedBy
|
gptkb:IEC_601-1
|
|
gptkbp:specifies
|
General requirements for basic safety and essential performance
|
|
gptkbp:usedFor
|
Certification of medical devices
|
|
gptkbp:usedIn
|
Clinical laboratory equipment approval
Home healthcare device approval
Hospital equipment approval
|
|
gptkbp:website
|
https://www.iec.ch/standards/iec60601-1
|
|
gptkbp:bfsParent
|
gptkb:IEC_60601
gptkb:IEC_62366
|
|
gptkbp:bfsLayer
|
6
|