GSO ISO/TR 80002-2:2021
ISO/TR 80002-2:2017
Gulf Standard
Current Edition
·
Approved on
01 July 2021
Medical device software — Part 2: Validation of software for medical device quality systems
GSO ISO/TR 80002-2:2021 Files
No files for this standard are available in the store currently.
GSO ISO/TR 80002-2:2021 Scope
ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service provision, and
- software used for the monitoring and measurement of requirements.
It does not apply to
- software used as a component, part or accessory of a medical device, or
- software that is itself a medical device.
Best Sellers From Health Sector
OS GSO 2017:2023
GSO 2017:2023
Omani Standard
Personal Care and Baby Wet Wipes
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
OS GSO 2241:2023
GSO 2241:2023
Omani Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
Recently Published from Health Sector
GSO ISO 19223-2:2026
ISO 19223-2:2025
Gulf Standard
Lung ventilators and related equipment — Vocabulary and semantics — Part 2: High frequency and jet ventilation
GSO ASTM F619:2026
ASTM F619:20(2025)
Gulf Standard
Standard Practice for Extraction of Materials Used in Medical Devices
GSO ISO 16687:2026
ISO 16687:2025
Gulf Standard
Impact assessment for museums
GSO CEN/TS 13387-4:2026
CEN/TS 13387-4:2025
Gulf Standard
Child care articles - General safety guidelines - Part 4: Thermal hazards
