Medical
14 references
Standards and regulations for medical devices, health software, and healthcare interoperability. Covers device safety, software lifecycle, risk management, quality systems, and clinical data exchange protocols.
| ID | Title | Label |
|---|---|---|
| Standard | ||
DICOM |
Digital Imaging and Communications in Medicine | Standard |
HL7-FHIR |
Health Level Seven Fast Healthcare Interoperability Resources | Standard |
IEC-60601-1 |
Medical electrical equipment — General requirements for basic safety and essential performance | Standard |
IEC-62304 |
Medical device software — Software life cycle processes | Standard |
IEC-62366 |
Medical devices — Application of usability engineering to medical devices | Standard |
IEC-80001-1 |
Application of risk management for IT-networks incorporating medical devices | Standard |
IEC-82304-1 |
Health software — General requirements for product safety | Standard |
IEEE-11073 |
Health informatics — Point-of-care medical device communication | Standard |
IHE |
Integrating the Healthcare Enterprise — Integration Profiles | Standard |
ISO-13485 |
Medical devices — Quality management systems — Requirements for regulatory purposes | Standard |
ISO-14971 |
Medical devices — Application of risk management to medical devices | Standard |
| Regulation | ||
EU-IVDR |
Regulation on in vitro diagnostic medical devices | Regulation |
EU-MDR |
Regulation on medical devices | Regulation |
FDA-21-CFR-820 |
Quality System Regulation | Regulation |