Circular No. 14/2018/TT-BKHCN issues three National Technical Regulations for X-ray equipment used in healthcare, including mobile devices, fluoroscopy machines, and dental units. This document sets out specific technical requirements for each type of equipment to ensure radiation safety and the quality of healthcare services.
Scope of application
Manufacturers, importers, users, and managers of X-ray equipment in the healthcare sector
Key points
- Manufacturers or importers of X-ray equipment must comply with the national technical regulations issued (Article 1).
- Organizations and individuals using X-ray equipment in healthcare must ensure inspection and certification according to the new regulations (Article 2).
- Certificates of inspection for fluoroscopy X-ray equipment issued before this Circular takes effect will still be recognized until re-inspection is required under the new National Technical Regulation QCVN 16:2018/BKHCN.
- The Radiation and Nuclear Safety Agency is responsible for guiding the implementation of this Circular (Article 3).
🌐 Social impact of this document
- Strengthening management of X-ray equipment quality to ensure safety for users and patients.
- Minimizing radiation risks during medical diagnostic procedures.
- Organizations manufacturing or importing X-ray equipment may face initial difficulties in complying with the new standards but will improve service quality over time.
❓ Frequently asked questions
Which X-ray equipment must comply with the National Technical Regulation QCVN 16:2018/BKHCN?
Fluoroscopy X-ray equipment used in healthcare.
Are certificates of inspection for X-ray equipment issued before this Circular takes effect still recognized?
Yes, but only until re-inspection is required under the new regulations.
Full text
CIRCULAR
Issuing three National Technical Regulations
concerning medical X-ray equipment
_____________________
Pursuant to the Atomic Energy Law on June 3, 2008;
Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006;
Pursuant to Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Standards and Technical Regulations;
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;
Decree No. 95/2017/NĐ-CP The Minister of Science and Technology issues this Circular promulgating National Technical Regulations for;
the Director the proposal of the Director of the Radiation and Nuclear Safety Agency and the Head of the Legal Department,
the Minister of Science and Technology promulgates three National Technical Regulations for medical X-ray equipment.
Article 1. The three National Technical Regulations for medical X-ray equipment set forth below are hereby promulgated together with this Circular:
1. National Technical Regulation on mobile medical X-ray equipment
Number: QCVN 15:2018/BKHCN.
2. National Technical Regulation on medical X-ray fluoroscopy equipment
Number: QCVN 16:2018/BKHCN.
3. National Technical Regulation on dental medical X-ray equipment
Number: QCVN 17:2018/BKHCN.
Article 2. This Circular shall take effect from June 1, 2019.
From the date this Circular takes effect, the provisions of Decision No. 32/2007/QĐ-BKHCN dated December 31, 2007 of the Minister of Science and Technology regarding the inspection of medical diagnostic X-ray equipment shall not apply to the testing of medical X-ray fluoroscopy equipment.
For medical X-ray fluoroscopy equipment that has been inspected before the date this Circular takes effect, the inspection certificate shall continue to be recognized until re-testing is required according to the National Technical Regulation QCVN 16:2018/BKHCN.
Article 3. The Director of the Radiation and Nuclear Safety Agency, heads of relevant agencies, organizations, and individuals are responsible for implementing this Circular.
Any difficulties or issues encountered during implementation should be promptly reported to the Ministry of Science and Technology for guidance or research on amendments and supplements./.
DEPUTY MINISTER
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