II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--extractables-leachables
extractables-leachables overview
Extractables and Leachables Analysis - Characterize extractable and leachable substances from medical device materials and assess toxicological risk to patients per ISO 10993-12 and ISO 10993-18.
Attributes
displayName
extractables-leachables
description
Extractables and Leachables Analysis - Characterize extractable and leachable substances
from medical device materials and assess toxicological risk to patients per ISO 10993-12 and ISO 10993-18.
libraryPath
library/specializations/domains/science/biomedical-engineering/extractables-leachables.js
specialization
biomedical-engineering
references
- - ISO 10993-12:2021 Sample preparation and reference materials - ISO 10993-18:2020 Chemical characterization of medical device materials - FDA Guidance on E&L Studies
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/extractables-leachables', {
deviceName: 'Drug-Eluting Stent',
materials: ['316L Stainless Steel', 'PLGA coating', 'Drug formulation'],
contactType: 'Circulating blood - Permanent',
extractionConditions: { solvents: ['Water', 'Ethanol', 'Hexane'] }
});
usesAgents
- general-purpose
Outgoing edges
lib_applies_to_domain1
- domain:biomedical-engineering·DomainBiomedical Engineering
lib_belongs_to_specialization1
- specialization:biomedical-engineering·SpecializationBiomedical Engineering
lib_implements_workflow2
- workflow:experiment-design·WorkflowExperiment Design
- workflow:peer-review-cycle·WorkflowPeer Review Cycle
lib_involves_role2
- role:biomedical-engineer·RoleBiomedical Engineer
- role:research-engineer·RoleResearch Engineer
lib_requires_skill_area3
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:sensor-fusion·SkillAreaSensor Fusion
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
Incoming edges
None.