Statements (57)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:standard
|
| gptkbp:bfsLayer |
8
|
| gptkbp:bfsParent |
gptkb:IEC_60601-1-6
|
| gptkbp:addresses |
user interface design
|
| gptkbp:aims_to |
ensure safety and performance of medical devices
|
| gptkbp:applies_to |
manufacturers of medical devices
medical electrical equipment software in medical devices |
| gptkbp:defines |
usability engineering process
|
| gptkbp:developed_by |
IEC Technical Committee 62
|
| gptkbp:emphasizes |
user-centered design
|
| gptkbp:facilitates |
training programs
|
| gptkbp:focuses_on |
usability
|
| gptkbp:includes |
usability testing
|
| gptkbp:includes_provisions_for |
labeling and instructions for use
|
| gptkbp:is_adopted_by |
gptkb:legislation
|
| gptkbp:is_aligned_with |
international safety standards
|
| gptkbp:is_available_on |
IEC webstore
|
| gptkbp:is_challenged_by |
rapid technological changes
|
| gptkbp:is_cited_in |
gptkb:ISO_13485
|
| gptkbp:is_compatible_with |
gptkb:ISO_14971
|
| gptkbp:is_connected_to |
patient outcomes
|
| gptkbp:is_critical_for |
regulatory approval
|
| gptkbp:is_designed_for |
patient safety
|
| gptkbp:is_designed_to |
designers of medical devices
|
| gptkbp:is_documented_in |
technical reports
|
| gptkbp:is_enhanced_by |
user experience research
|
| gptkbp:is_essential_for |
effective user training
|
| gptkbp:is_evaluated_by |
performance metrics
clinical trials |
| gptkbp:is_influenced_by |
user feedback
|
| gptkbp:is_informed_by |
emerging technologies
|
| gptkbp:is_integrated_with |
quality management systems
|
| gptkbp:is_often_used_in |
in various countries
|
| gptkbp:is_part_of |
medical device regulation
risk management framework medical device lifecycle management |
| gptkbp:is_promoted_by |
healthcare organizations
|
| gptkbp:is_referenced_in |
FDA guidelines
academic research. |
| gptkbp:is_related_to |
human factors engineering
|
| gptkbp:is_reviewed_by |
peer experts
|
| gptkbp:is_subject_to |
periodic review
|
| gptkbp:is_supported_by |
stakeholder engagement
industry associations |
| gptkbp:is_used_for |
evaluating usability of medical devices
|
| gptkbp:is_used_in |
healthcare industry
|
| gptkbp:part_of |
gptkb:IEC_60601_series
|
| gptkbp:provides |
guidelines for risk management
|
| gptkbp:published_by |
gptkb:International_Electrotechnical_Commission
IEC standards catalog |
| gptkbp:published_year |
gptkb:2019
|
| gptkbp:related_to |
gptkb:ISO_9241
|
| gptkbp:replaced_by |
IEC 60601-1-6:2010
|
| gptkbp:supports |
compliance with safety standards
|
| gptkbp:title |
Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
|
| gptkbp:updates |
IEC 60601-1-6:2023
|