Medical device function
Medical device function, Total:20 items.
The international standard classification for "Medical device function" includes: Medical equipment , Medical equipment in general , Quality management and quality assurance .
The Chinese standard classification for "Medical device function" includes: Medical apparatus and devices in general .
Professional Standard - Medicine
- YY/T 0316-2016 Medical devices-Application of risk management to medical devices
- YY/T 1437-2023 Medical devices-Guidance on the application of GB/T 42062
- YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
- YY/T 0869.2-2016 Medical devices-Hierarchical coding structure for adverse events一 Part 2:Evaluation codes
- YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
- YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
- YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software
- YY/T 1474-2016 Medical devices－Application of risk management to medical devices
Professional Standard - Post and Telecommunication
- YD/T 6284-2024 Technical requirements for intelligent medical device cybersecurity capabilities
Group Standards of the People's Republic of China
- T/ZMDS 20003-2019 Medical device security risk control – information of medical device security capabilities
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 42062-2022 Medical devices—Application of risk management to medical devices
Jiangsu Provincial Standard of the People's Republic of China
- DB32/T 3769-2020 Basic requirements for medical device network information security
Guangdong Provincial Standard of the People's Republic of China
- DB4403/T 220-2021 Assignment Rules for Medical Device Product Identification
Gosstandart of Russia
- GOST R 58450-2019 Medical devices with measuring functions. Condition monitoring
- GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
Association Francaise de Normalisation
- NF S90-305:1986 MEDICO-SURGICAL EQUIPMENT. PERITONEAL DIALYSIS CYCLER. FUNCTIONAL APTITUDE.
- NF C74-208/A1:2001 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
Korean Agency for Technology and Standards (KATS)
- KS C IEC 60976-2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
- KS C IEC 60976:2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
GCC Standardization Organization
- BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
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