IEC 60601-1

GPTKB entity

Statements (57)
Predicate Object
gptkbp:instance_of gptkb:standard
gptkbp:bfsLayer 8
gptkbp:bfsParent gptkb:IEC_60601-1-2
gptkb:IEC_60601-1-8
gptkbp:aims_to patient safety
gptkbp:amended_by gptkb:2005
gptkbp:applies_to medical electrical equipment
gptkbp:complement IEC 60601-1-11
IEC 60601-1-9
IEC 62304
gptkbp:first_published gptkb:1977
gptkbp:focuses_on safety and performance
https://www.w3.org/2000/01/rdf-schema#label IEC 60601-1
gptkbp:includes_provisions_for electrical safety
software safety
mechanical safety
thermal safety
gptkbp:is_adopted_by gptkb:legislation
gptkb:Australia
gptkb:Brazil
gptkb:China
gptkb:India
gptkb:Japan
gptkb:South_Africa
gptkb:United_States
gptkb:Native_American_tribe
clinical settings
gptkbp:is_challenged_by emerging technologies
gptkbp:is_cited_in medical device regulations
gptkbp:is_critical_for market access
gptkbp:is_criticized_for complexity
cost implications
gptkbp:is_discussed_in academic literature
gptkbp:is_documented_in technical reports
gptkbp:is_essential_for gptkb:hospital
therapeutic devices
life-support systems
patient monitoring devices
gptkbp:is_evaluated_by risk management processes
gptkbp:is_influenced_by advancements in technology
gptkbp:is_part_of IEC 60601 family of standards
gptkbp:is_promoted_by industry associations
gptkbp:is_referenced_in gptkb:ISO_13485
gptkbp:is_reviewed_by industry experts
gptkbp:is_supported_by gptkb:municipality
technical committees
gptkbp:is_tested_for performance standards
gptkbp:is_used_for designing medical devices
gptkbp:published_by gptkb:International_Electrotechnical_Commission
gptkbp:regulatory_compliance regulatory bodies
gptkbp:related_to gptkb:IEC_60601_series
gptkbp:requires many countries
gptkbp:title Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
gptkbp:updates gptkb:IEC_60601-1-2
gptkb:IEC_60601-1-6
gptkb:IEC_60601-1-8
gptkbp:used_in healthcare industry