GB/T 21715.1-2008
Replaced
GB/T 44585.1-2024
Active
National standards
GB/T 44585.1-2024 Application of risk management for medical device connecting IT-network—Part 1:Safety,effectiveness and security in the implementation and use of connected medical devices or connected health software
GB/T 44585.1-2024 Application of risk management for medical device connecting IT-network—Part 1:Safety,effectiveness and security in the implementation and use of connected medical devices or connected health software
Price:
$ 105
Basic Information
Standard Code:
GB/T 44585.1-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
The application of information technology in medical and health technologies
Publish Date:
2024-09-29
Implement Date:
2026-04-01
Pages:
40 pages
Scope
This document specifies the general requirements for risk management of three key attributes—security, effectiveness, and cybersecurity—in health IT infrastructure by involving appropriate stakeholders at the same time, before, during, and after connecting health IT systems.
This document is applicable to risk management during the implementation and use phases of networked medical devices or health software throughout their lifecycle.
Development Information
Adopt standards
IEC 80001-1:2021
Related Standards
GB/T 21715.2-2008
Replaced
GB/T 21715.2-2008 Health informatics—Patient healthcard data—Part 2:Common objects
GB/T 21715.3-2008
Replaced
GB/T 21715.3-2008 Health informatics—Patient healthcard data—Part 3:Limited clinical data
GB/Z 21716.1-2008
Replaced
GB/Z 21716.1-2008 Health informatics—Public Key Infrastructure (PKI)—Part 1:Overview of digital certificate services
GB/Z 21716.2-2008
Replaced
GB/Z 21716.2-2008 Health informatics—Public Key Infrastructure (PKI)—Part 2:Certificate profile
GB/Z 21716.3-2008
Replaced