GSO IEC 80001-1:2024
IEC 80001-1:2021
Gulf Standard
Current Edition
·
Approved on
14 October 2024
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
GSO IEC 80001-1:2024 Files
English
75 Pages
Current Edition
Reference Language
Obtaining this standard through the store is currently unavailable. You can acquire it directly from its source.
GSO IEC 80001-1:2024 Scope
IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.
IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
YSMO GSO 2017:2023
GSO 2017:2023
Yemeni 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)
Recently Published from Health Sector
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
GSO EN 16779-2:2025
EN 16779-2:2022
Gulf Standard
Textile child care articles - Safety requirements and test methods for children's cot duvets - Part 2: Duvet covers (excluding duvet)
GSO EN 16120:2012+A2:2025
EN 16120:2012+A2:2016
Gulf Standard
Child use and care articles - Chair mounted seat