ISO/TR 80002-2:2017
International Standard
Current Edition
·
Approved on
13 June 2017
Medical device software — Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Files
English
84 Pages
Current Edition
105.96 OMR
ISO/TR 80002-2:2017 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
GSO 150-2:2013
Gulf Standard
Expiration dates for food products - Part 2 :
Voluntary expiration dates
OS GSO 150-2:2013
GSO 150-2:2013
Omani Standard
Expiration dates for food products - Part 2 :
Voluntary expiration dates
OS GSO 2055-1:2015
GSO 2055-1:2015
Omani Standard
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements
Recently Published
ISO 37303:2025
International Standard
Compliance management systems — Guidance for competence management
ISO 37302:2025
International Standard
Compliance management systems — Guidance for the evaluation of effectiveness
ISO 21740:2025
International Standard
Space systems — Launch window estimation and collision avoidance
ISO 7899-3:2025
International Standard
Water quality — Enumeration of intestinal enterococci — Part 3: Most probable number method