IEC 60601-1-8

GPTKB entity

Statements (55)
Predicate Object
gptkbp:instance_of gptkb:standard
gptkbp:bfsLayer 7
gptkbp:bfsParent gptkb:IEC_60601_series
gptkbp:addresses user interface design
gptkbp:aims_to patient safety
gptkbp:amended_by gptkb:2012
gptkbp:applies_to gptkb:hospital
monitoring equipment
gptkbp:collaborated_with international committees
gptkbp:developed_by IECTC 62
gptkbp:education_institution gptkb:hospital
gptkbp:first_published gptkb:2006
gptkbp:focuses_on alarm systems in medical electrical equipment
https://www.w3.org/2000/01/rdf-schema#label IEC 60601-1-8
gptkbp:includes performance testing
gptkbp:includes_provisions_for audible alarms
visual alarms
gptkbp:is_adopted_by gptkb:legislation
gptkb:various_countries
healthcare organizations
gptkbp:is_aligned_with international safety standards
gptkbp:is_cited_in gptkb:ISO_13485
gptkbp:is_compatible_with gptkb:ISO_14971
gptkbp:is_critical_for safety in medical devices
gptkbp:is_essential_for device certification
gptkbp:is_evaluated_by regulatory bodies
usability
gptkbp:is_influenced_by clinical practices
gptkbp:is_informed_by user feedback
gptkbp:is_integrated_with gptkb:software
medical device design process
gptkbp:is_part_of quality management systems
medical device lifecycle management
medical device regulatory framework
gptkbp:is_promoted_by medical associations
gptkbp:is_referenced_in gptkb:municipality
FDA regulations
gptkbp:is_related_to gptkb:IEC_60601-1
risk management
gptkbp:is_reviewed_by industry experts
gptkbp:is_subject_to periodic review
gptkbp:is_supported_by gptkb:document
training programs
gptkbp:is_tested_for performance standards
compatibility
gptkbp:is_used_for patient monitoring systems
gptkbp:is_used_in hospitals
gptkbp:part_of gptkb:IEC_60601_series
gptkbp:provides_information_on alarm management
gptkbp:published_by gptkb:International_Electrotechnical_Commission
IEC publications
gptkbp:requires medical device manufacturers
gptkbp:specifies requirements for alarm signals
gptkbp:title General requirements for basic safety and essential performance of medical electrical equipment
gptkbp:updates gptkb:IEC_60601-1-8:2012