Circular No. 28/2015/TT-BKHCN promulgates the National Technical Regulation for general-purpose X-ray equipment used in healthcare, effective from June 1, 2016. Previous regulations on medical diagnostic X-ray equipment inspection no longer apply to general-purpose X-ray equipment.
要点
- General-purpose X-ray equipment used in healthcare must comply with the National Technical Regulation QCVN 11: 2015/BKHCN.
- This Circular takes effect from June 1, 2016.
- General-purpose X-ray equipment that has been inspected before this Circular takes effect will still be recognized until re-inspection is required.
- The Radiation and Nuclear Safety Agency is responsible for implementing this Circular.
🌐 本文件的社会影响
- Positive impact: Ensuring safety and quality in the use of general-purpose X-ray equipment in healthcare.
- Negative impact: Investment is needed to comply with new standards, which may impose a burden on healthcare facilities.
❓ 常见问题
How does the National Technical Regulation QCVN 11: 2015/BKHCN apply to general-purpose X-ray equipment?
General-purpose X-ray equipment used in healthcare must comply with the National Technical Regulation QCVN 11: 2015/BKHCN.
When does this Circular take effect?
This Circular takes effect from June 1, 2016.
Is general-purpose X-ray equipment that was inspected before this Circular takes effect still recognized?
General-purpose X-ray equipment that was inspected before this Circular takes effect will still be recognized until re-inspection is required.
Which agency is responsible for implementing this Circular?
The Radiation and Nuclear Safety Agency is responsible for implementing this Circular.
What does this Circular replace?
This Circular replaces the provisions set forth in Decision No. 32/2007/QĐ-BKHCN of the Minister of Science and Technology regarding the inspection of medical diagnostic X-ray equipment.
全文
CIRCULAR
ISSUING "NATIONAL TECHNICAL REGULATION ON COMPUTED TOMOGRAPHY EQUIPMENT USED IN MEDICINE" "medical diagnostic X-ray equipment"
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Pursuant to Decree No. 20/2013/NĐ-CP dated February 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;
BASED ON THE DECREE NO. 07/2010/NĐ-CP OF JANUARY 25, 2010 PROVIDING GUIDELINES FOR IMPLEMENTATION OF CERTAIN PROVISIONS OF THE LAW ON ATOMIC ENERGY;
Based on Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions
At the proposal of the Director of the Radiation and Nuclear Safety Agency and the Department of Legal Affairs,
The Minister of Science and Technology promulgates the National Technical Regulation on medical diagnostic X-ray equipment.
Article 1. Accompanying this Circular is the National Technical Regulation on medical diagnostic X-ray equipment (QCVN 11: 2015/BKHCN).
Article 2. This Circular takes effect from June 1, 2016.
From the date this Circular takes effect, the provisions of Decision No. 32/2007/QĐ-BKHCN of the Minister of Science and Technology dated December 31, 2007 on the inspection of medical diagnostic X-ray equipment shall not apply to the testing of medical diagnostic X-ray equipment.
For medical diagnostic X-ray equipment that has been tested before the date this Circular takes effect, the test certification will still be recognized until it must be retested according to the law.
Article 3. THE DIRECTOR OF THE RADIATION AND NUCLEAR SAFETY AGENCY, HEADS OF ORGANIZATIONS AND INDIVIDUALS CONCERNED ARE RESPONSIBLE FOR ENFORCING THIS CIRCULAR.
DURING THE IMPLEMENTATION, IF THERE ARE ANY DIFFICULTIES, ORGANIZATIONS, ORGANIZATIONS, AND INDIVIDUALS SHOULD PROMPTLY REPORT TO THE MINISTRY OF SCIENCE AND TECHNOLOGY FOR STUDY AND AMENDMENT./.
DEPUTY MINISTER
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