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
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023
Bahraini Standard
Personal Care and Baby Wet Wipes
BH GSO 2241:2023
GSO 2241:2023
Bahraini Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
Recently Published from Health Sector
GSO ISO 22112:2025
ISO 22112:2017
Gulf Standard
Dentistry — Artificial teeth for dental prostheses
GSO EN 14988:2017+A2:2025
EN 14988:2017+A2:2024
Gulf Standard
Children's high chairs - Requirements and test methods
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
