T/ZGCMITT 004-2021
TUANTI · 2021-08-01
DSA-guided minimally invasive operating room configuration requirements
2Expert Interpretation
An in-depth analysis of the T/ZGCMITT 004-2021 group standard "DSA Interventional Operating Room Configuration Requirements", covering core content such as operating room construction specifications, equipment technical parameters, radiation safety protection, and providing implementation recommendations in accordance with GB 50333 and IEC standards.
Interpretation of the standard technical framework
| Core module | Technical requirements | Reference standards |
|---|---|---|
| Spatial layout | Three-zone division (restricted area/semi-restricted area/unrestricted area) | GB 50333-2013 |
| DSA equipment | Detector size ≥30cm×30cm, heat capacity ≥1.5MHU | YY/T 0740-2009 |
| Radiation protection | Dose threshold reminder function, deviation ≤±35% | IEC 60601-2-43:2019 |
Key equipment technical specifications
DSA system configuration points
- 3D reconstruction function: visibility ≥10HU at 10mm thickness
- Catheter bed load: ≥200kg and longitudinal movement ≥1100mm
- C-arm rotation range: -105°~+105° (deviation ±2°)
Actual application case
The DSA system configured in the neurointervention center of a tertiary hospital class=instrument>DSA equipment uses a 40cm×40cm flat-panel detector, combined with an automatic dose tracking system, to reduce surgical radiation dose by 32%.
Standard Evolution Analysis
Compared with the earlier version, this standard adds:
- Mandatory requirement for dose area product (DAP) display function
- Clarify the biosafety requirements for chemotherapy drug preparation areas
- Refine the anesthesia system docking specification (GB 9706.29-2006)
Implementation recommendations
Construction phase
- Give priority to the separation design of the C-arm rack and the catheter bed (Standard Clause 5.1.2)
- Regular testing of floating bacteria is required for the air purification system (WS/T 367-2012)
Operation and maintenance management
- Establish a dosage report traceability system (IEC 61910-1:2014)
- Medicines in emergency vehicles are classified and managed in accordance with clause 6.4.2.3 of the standard
3Version History
T/ZGCMITT 004-2021
2021-08-01
5Citation Network
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Cite this standard
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Referenced herein
Referenced by T/ZGCMITT 004-2021
GB 15982-2012
GB 50333-2013
GB 9706.29-2006
GB 9706.8-2009
GB/T 12190-2006
GBZ 130-2020
IEC 60601-2-43
IEC 61910-1
6Frequently Asked Questions
What is T/ZGCMITT 004-2021?
T/ZGCMITT 004-2021 — DSA-guided minimally invasive operating room configuration requirements is an international standard developed by Group Standards of the People's Republic of China.
What does T/ZGCMITT 004-2021 cover?
This standard covers:
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in the medical device and healthcare industry. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of T/ZGCMITT 004-2021?
The current published version is T/ZGCMITT 004-2021, published on 2021-08-01. Always check for amendments or pending revisions.
How do I purchase T/ZGCMITT 004-2021?
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