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 2063:2023
Gulf Standard
Cosmetic Products - Hair Conditioner (Balsam)
GSO 1223:2023
Gulf Standard
Cosmetic Products-Deodorants
Recently Published from Health Sector
GSO ISO 12219-9:2025
ISO 12219-9:2019
Gulf Standard
Interior air of road vehicles — Part 9: Determination of the emissions of volatile organic compounds from vehicle interior parts — Large bag method
GSO ASTM E3356:2025
ASTM E3356:22
Gulf Standard
Standard Guide for Stakeholder Engagement on Environmental Risk Management and Climate
GSO ASTM E3032:2025
ASTM E3032:22
Gulf Standard
Standard Guide for Climate Resiliency Planning and Strategy
GSO ISO 12219-1:2025
ISO 12219-1:2021
Gulf Standard
Interior air of road vehicles — Part 1: Whole vehicle test chamber — Specification and method for the determination of volatile organic compounds in cabin interiors
Select GSO Member Stores
