Statements (62)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:standard
|
| gptkbp:bfsLayer |
5
|
| gptkbp:bfsParent |
gptkb:ISO_14971
|
| gptkbp:addresses |
user interface design
|
| gptkbp:aims_to |
reduce use-related hazards
|
| gptkbp:amended_by |
gptkb:2015
|
| gptkbp:applies_to |
gptkb:hospital
software medical devices |
| gptkbp:emphasizes |
user-centered design
|
| gptkbp:first_published |
gptkb:2007
|
| gptkbp:focuses_on |
usability engineering
|
| gptkbp:has_documentation |
usability engineering process
|
| https://www.w3.org/2000/01/rdf-schema#label |
IEC 62366
|
| gptkbp:includes |
risk management principles
|
| gptkbp:is_a_framework_for |
usability evaluation
|
| gptkbp:is_adopted_by |
multiple countries
healthcare organizations |
| gptkbp:is_aligned_with |
gptkb:ISO_13485
|
| gptkbp:is_associated_with |
user feedback
|
| gptkbp:is_cited_in |
medical device risk assessments
|
| gptkbp:is_considered |
post-market surveillance
clinical evaluations |
| gptkbp:is_critical_for |
patient safety
|
| gptkbp:is_discussed_in |
conferences
academic literature |
| gptkbp:is_essential_for |
product development
|
| gptkbp:is_evaluated_by |
regulatory bodies
user testing usability studies usability criteria |
| gptkbp:is_implemented_in |
design processes
|
| gptkbp:is_incorporated_in |
design specifications
|
| gptkbp:is_influenced_by |
human factors engineering
|
| gptkbp:is_informed_by |
clinical studies
user research |
| gptkbp:is_integrated_with |
quality management systems
product design. |
| gptkbp:is_linked_to |
patient outcomes
|
| gptkbp:is_part_of |
gptkb:IEC_60601_series
regulatory compliance regulatory submissions medical device regulations medical device lifecycle |
| gptkbp:is_promoted_by |
professional organizations
|
| gptkbp:is_referenced_in |
FDA guidelines
design control documentation |
| gptkbp:is_related_to |
gptkb:ISO_9241
gptkb:ISO_14971 user experience design |
| gptkbp:is_supported_by |
training programs
industry standards |
| gptkbp:is_used_by |
medical device manufacturers
|
| gptkbp:is_used_for |
design validation
|
| gptkbp:is_used_to |
identify user needs
|
| gptkbp:is_utilized_in |
risk assessment
product testing |
| gptkbp:provides_information_on |
best practices
usability testing |
| gptkbp:published_by |
gptkb:International_Electrotechnical_Commission
|
| gptkbp:requires |
CE marking in Europe
|
| gptkbp:title |
Medical devices -Application of usability engineering to medical devices
|
| gptkbp:updates |
IEC 62366-1
|