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.
Obtaining this standard through the store is currently unavailable.
You can acquire it directly from its source or from one of the member countries stores
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
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2156:2023
Gulf Standard
Cosmetic Products – Natural Henna
GSO 2063:2023
Gulf Standard
Cosmetic Products - Hair Conditioner (Balsam)
Recently Published from Health Sector
GSO ISO 1797:2025
ISO 1797:2017
Gulf Standard
Dentistry — Shanks for rotary and oscillating instruments
GSO ISO 16571:2025
ISO 16571:2024
Gulf Standard
Systems for evacuation of plume generated by medical devices
GSO ISO 25649-4:2025
ISO 25649-4:2024
Gulf Standard
Floating leisure articles for use on and in the water — Part 4: Additional specific safety requirements and test methods for Class B devices
GSO ASTM F1004:2025
ASTM F1004:23
Gulf Standard
Standard Consumer Safety Specification for Expansion Gates and Expandable Enclosures
Select GSO Member Stores
