Công văn 1092/BKHCNMT-ATBX

To: Provincial/City Departments of Science, Technology and Environment

Based on decentralisaion provisions specified in the Joint Circular No. 2237/1999/TTLT/BKHCNMT-BYT jointly issued by the Ministry of Science, Technology and Environment and the Ministry of Health, dated 28 December 1999, Provincial/City Departments of Science, Technology and Environment shall issuse licenses for radiation safety for facilities using X-ray equipment in medicine. For the consistent authorisation, the Ministry of Science, Technology and Environment provisionally prescribe the following requirements and conditions for licence application for using X-ray equipment in medicine:

A/ Documents required for licence application for using X-ray diagnosis equipment shall include:

1- An application form (Form 1)

2- A notification of the X-ray diagnosis equipment (Form 2)

3- Technical documents of the X-ray diagnosis equipment: technical specification, user’s manual, and equipment certificate issued by the producing country’s authority. The X-ray equipment installed before 2002 are not required to submit the equipment certificate issued by the producing country’s authority.

4- Documents related to quality assessment of the X-ray equipment. (Report of quality assessment for X-ray equipment shall be made by an organisation or individual licensed for conducting services by the Ministry of Science, Technology and Environment and within at least 3 years after the assessment).

5- Notification of a radiation safety officer (Form 3), a copy of the decision on the safety officer appointment, a copy of the safety officer's certificate on radiation safety granted by an organisation authorised by the Ministry of Science and Technology to provide training on radiation safety, and notification of radiation workers (Form 4).

6- A table of personal radiation doses of radiation workers in the last 3 years (attached with copies of radiation results measured by an organisation providing dose measuring services), or a contract with the service organisation authorised by the the Ministry of Science, Technology and Environment (for those facilities that lodge their first application and have not been monitoring radiation workers’ doses).

7- Working regulations of the facility and a working procedure with the X-ray equipment.

8- An assessment of radiation safety (Form 5).

9- Notification of radiation alarms and dose mearsuring equipment.

10- Notification of X-ray quality assessment equipment.

B/ Requirements for a licence to be granted for using X-ray equipment in medicine

1. Manpower

a/ There shall be a sufficient number of workers for X-ray equipment operation. Workers operating the equipment shall have certificates on X-ray diagnosis granted by a training organisation authorised by the Ministry of Health and certificates on radiation safety.

b/ There shall be a radiation safety officer appointed by the head of the facility. The safety officer must have a certificate on X-ray diagnosis granted by a training organisation authorised by the Ministry of Helth and a certificate on radiation safety granted by an organisation authorised by the Ministry of Science, Technology and Environment to provide training on radiation safety.

2. X-ray room

a/ X-ray room location: The provisions specified in the Joint Circular No. 2237/1999/TTLT/BKHCNMT-BYT jointly issued by the Ministry of Science, Technology and Environment and the Ministry of Health, dated 28 December 1999, apply to all X-ray, irradiation and nuclear medicine facilities although the provisions for the location of radiation equipment are not suitable for X-ray equipment as the X-ray equipment only irradiates when it is in operation, not causing radioactive contamination. Therefore, X-ray rooms can be situated in resident areas if the requirements for shielding as specified in the following provisions are met

b/ Radiation protection: Walls and doors of the X-ray room shall have sufficient thickness/density so as to ensure the dose rate in the vinicity of the walls and doors not higher than 0.5 µSv/h (where the public is present) or not higher than 3/10 of the dose limitation for radiation workers (3µSv/h) at the place where operaters work, regardless of the natural radiation background.

In the case that the X-ray room is situated in between 2 houses, the radiation dose rate at any place in the two houses must be the same as the natural radiation background.

c/ X-ray equipment arrangement: The arrangment for X-ray equipment shall be complied with point a, b item 1, article V as specified in the above-mentioned Joint Circular.

d/ Area of an X-ray room: The area of an X-ray room shall be as follows (however, it is encouraged to comply with the TCVN6561:1999):

- X-ray room with no patient table: the room must be larger than or equal to 12m2 and each side must not be less than 3m long.

- X-ray room with mobile or fix patient tables: the room must be larger than or equal to 14m2, each side must not be less than than 3.5m long.

- X-ray room with tilt tables, the the room must be larger than or equal to 20m2, each side must not be less than 3.5m long.

- In case that the design of X-ray room adviced by the producer is available, the minimum area of the room shall be equal to or larger than that suggested by the producer.

The control pannel must be out side of the X-ray rooms of the above-mentioned sizes.

3. Personal protection

X-ray workers must be equipped with safety apron and gloves suitable for the work (the appropriate density in lead equivalent shall be shown on the apron or gloves), and suitable protection equipment such as lead shielding. Radiation workers shall have personal dosemeter and be periodically checked.

4. Radiation safety assurance program

Facilities shall implement a radiation safety assurance program (Form 5).

5. Quality of X-ray equipment

a/ X-ray equipment shall comply with statndards set out by the International Electronic Committee (IEC), ISO or Vietnamese Standards.

b/ X-ray equipment shall be annually assessed by an organisation authorised by the Ministry of Science, Technology and Environment. Results should meet the requirements (based on the report from the assessment).

The assessing procedure shall comply with the Quality ĐLVN 41:1999: Normal diagnostic X-ray equipment – Assessment Procedure, ĐLVN 42:1999: CT scanner - Assessment Procedure, and ĐLVN 65:2000: Television bright-raising X-ray equipment - Assessment Procedure, issued by Directorate Standards and Quality (STAMEQ).

At present, due to the shortage of services for quality assessment for X-ray equipment, Provincial/City Departments of Science and Technology can grant licenses to facilities that meet all the requirements, except the requirement for equipment assessment. However, it shall be clearly written in the license that: “The facility must carry out quality checking of X-ray equipment within 2 years after the license is granted”.

C/ License duration:

License for using X-ray equipment is valid for 3 years.

Provincial/City Departments of Science, Technology and Environtment are requested to implement the issuance of radiation safety licence to X-ray facilities as stipulated by law.