Circular No. 09/2023/TT-BKHCN issues National Technical Regulation QCVN 24:2023/BKHCN for bone density measuring X-ray equipment used in healthcare, specifying technical requirements and radiation safety standards for such equipment. The document takes effect from July 15, 2023.
适用范围
Organizations and individuals producing, importing, inspecting, and using bone density measuring X-ray equipment in healthcare
要点
- Bone density measuring X-ray equipment must meet technical requirements and radiation safety standards according to regulation QCVN 24:2023/BKHCN (Article 1).
- As of December 1, 2023, new equipment put into use must comply with the requirements set forth in this regulation (Article 3.1).
- Equipment produced after January 1, 2017 must be equipped with a phantom for evaluating bone density accuracy by May 25, 2024 (Article 3.2.b).
- Certificates of inspection still valid for old equipment will continue to be recognized until re-inspection is required under the new regulations (Article 3.2.a).
- The Radiation and Nuclear Safety Agency is responsible for organizing, guiding, and disseminating National Technical Regulation QCVN 24:2023/BKHCN
🌐 本文件的社会影响
- Enhancing radiation safety for users of bone density measuring X-ray equipment
- Ensuring the quality and accuracy of bone density measurement results, improving diagnostic effectiveness in healthcare
- Financial burden on investment and maintenance of bone density measuring X-ray equipment for healthcare organizations
❓ 常见问题
When must new bone density measuring X-ray equipment comply with regulation QCVN 24:2023/BKHCN?
As of December 1, 2023.
Bone density measuring X-ray equipment produced after January 1, 2017 must be equipped with a phantom for evaluating bone density accuracy by when?
By May 25, 2024.
Can certificates of inspection still valid for old equipment be recognized?
Yes, they will continue to be recognized until re-inspection is required under the new regulations.
全文
CIRCULAR
Issuing National Technical Regulations
concerning bone density measurement X-ray devices used in healthcare
_________________________
Camendpursuant to the Atomic Energy Law dated June 3, 2008;
pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;ỹadopted on June 29, 2006;
pursuant to Decree No. 07/2010/NĐ-CP dated January 25, 2010 of the Government detailing and guiding the implementation of certain provisions of the Atomic Energy Law;0Decree No. 27/2007/NĐ-CP dated August 1, 2007 of the Government detailing the implementation of certain provisions of the Law on Standards and Technical Regulations; Decree No.toguiding the implementation of certain Articles of the Atomic Energy Law;
Pursuant to Decree No.1Decree No. 27/2007/NĐ-CP dated August 1, 2007 of the Government detailing the implementation of certain provisions of the Law on Standards and Technical Regulations;78/2018/NĐ-CP dated May 16, 2018, AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS OF DECREE NO.127/2007/NĐ-CPdated August 1, 2007, issued by the Government detailing the implementation of certain Articles of the Law on Technical Standards and Regulations;
Pursuant to Decree No.Decree No. 95/2017/NĐ-CP dated August 16, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;-CPdated August 16, 2017, issued by the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Sciencetoand Technology;
At the proposal of the Director of the Radiation and Nuclear Safety Administration and the Head of the Legal Department;
The Minister of Science and Technology issues this Circular promulgating the National Technical Regulation for bone density measurement X-ray devices used in healthcare.At the request of the Inspectorate of theequipment for bone density measurement X-ray devices used in healthcare.policies.
Article 1. This Circular promulgates the National Technical Regulation for bone density measurement X-ray devices used in healthcare.
Regulation number: QCVN 24:2023/BKHCN.
Article 2. Effective Date
This Circular takes effect from July 15, 2023.
Article 3. Implementation Schedule
1. As of December 1, 2023, bone density measurement X-ray devices used in healthcare must comply with the provisions of the National Technical Regulation QCVN 24:2023/BKHCN.
2. For bone density measurement X-ray devices put into use before the effective date of QCVN 24:2023/BKHCN:
a) Valid calibration certificates will continue to be recognized until they need to be recalibrated according to the provisions of QCVN 24:2023/BKHCN;
b) In cases where the device was manufactured after January 1, 2017, organizations and individuals using the device must equip a phantom for assessing bone density accuracy for each device according to Clause 4.1.2 of QCVN 24:2023/BKHCN by May 25, 2024.
Article 4. Organization of Implementation
1. The Director of the Radiation and Nuclear Safety Agency shall be responsible for organizing, guiding, disseminating, promoting, and implementing this Circular.
2. The Minister, Head of a ministerial-level agency, Chairman of the People's Committee of a province or centrally governed city, and relevant agencies, organizations, and individuals are responsible for enforcing this Circular.
3. During the implementation process, if there are difficulties, agencies, organizations, and individuals shall promptly reflect them in writing to the Ministry of Science and Technology for guidance or research and amendment to ensure compliance./.
DEPUTY MINISTER
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