放射性物質或可發生游離輻射設備操作人員管理辦法

This Regulations is enacted pursuant to Paragraph 3 of Article 31 of the Ionizing Radiation Protection Act (hereinafter referred to as "this Act").

1The radiation-related licenses or certificates stipulated in the proviso of Paragraph 1 of Article 31 of this Act refer to the following:

21.Radiology or nuclear medicine specialist license.

32.License issued in accordance with the Medical Radiation Technologists Act.

43.Authorization certificate of radiation protection personnel issued in accordance with the provisions of Paragraph 3 of Article 7 of this Act.

54.Certificate of operators issued in accordance with the provisions of Paragraph 5 of Article 29 and Paragraph 2 of Article 30 of this Act.

1Persons engaged in operation training under the direction of qualified personnel, based on educational need, as stipulated in the proviso of Paragraph 1 of Article 31 of this Act, are as follows:

21.Teachers, researchers, and students from secondary schools, colleges, universities, and academic research institutions.

32.Students at radiation protection training institutions authorized by the competent authority.

43.Doctors or dentists receiving clinical training or students or graduates of a medical school with a hospital practicum.

54.New recruits who are receiving pre-employment training.

6The period of operation training provided under the direction of qualified personnel to the persons as set forth in the Subparagraph 4 of the preceding paragraph shall be limited to a maximum of six months.

7The persons referred to in Paragraph 1 shall, before operating radioactive material or equipment capable of producing ionizing radiation, attend lectures on operating procedures and radiation protection planned by qualified personnel. However, when operating portable or non-fixed-shielding radioactive material or equipment capable of producing ionizing radiation for which the competent authority has issued a certificate of permission, it shall still be necessary to be directly supervised by qualified personnel.

1Personnel operating radioactive material or equipment capable of producing ionizing radiation shall, except for the conditions stipulated in the proviso of Paragraph 1 of Article 31 of this Act, meet one of the following important conditions and obtain certification; following passing the test conducted by the competent authority, said personnel shall fill out an application form and send it to the competent authority requesting the issuance of a radiation safety certificate

21.Undergo training from a radiation protection training provider that is authorized by the competent authority in line with procedures stipulated in Table 2 of the Regulations for Administration of Radiation Protection Service Related Business.

32.Obtain more than four credits in radiation protection-related courses, as specified in the attachment to the Administrative Regulations for Radiation Protection Personnel, taken at a public or legally registered private college or university in Taiwan, or at a foreign institution recognized by the Ministry of Education.

43.Attend an ionizing radiation protection lecture course authorized or commissioned by the competent authority prior to the coming into force of this Act.

5The training referred to in Subparagraph 1 of the preceding paragraph shall not be substituted by the training stipulated in Subparagraph 1 of Paragraph 1 of Article 6.

6When, in fulfilling the requirements of an agreement for contracting, buying and selling, technical cooperation, a foreigner does work in the ROC within the scope of said agreement and must operate radioactive material or equipment capable of producing ionizing radiation, the facility operator who has made the agreement shall submit a photocopy of foreign certification of operating or radiation protection training for said foreigner, apply to the competent authority for review and obtain qualification before said foreigner may engage in said work.

1The specific radioactivity or specific energy levels stipulated in Paragraph 2 of Article 31 of this Act are as follows:

21.Sealed radioactive materials defined in Category IV and Category V.

32.Radioactive material that forms a component of an instrument or manufactured product and that has a radioactivity less than 1,000 times that of the exemption level and the surface dose rate at an accessible distance of 5 cm is 5 μSv/h.

43.Radioactive materials besides those mentioned in the preceding two subparagraphs with a radioactive level of 100 times that of the exemption level.

54.For equipment capable of producing ionizing radiation, the nominal voltage is 150 kV or the particle energy is 150 keV.

65.Cabinet or baggage inspection X-ray machine, ion implanter, electron beam welding machine or static eliminator, the surface dose rate at an accessible distance of 5 cm is 5 μSv/h.

76. Other materials or equipment as designated by the competent authority.

1The training stipulated in Paragraph 2 of Article 31 of this Act refers to one of the following, and with training certification:

21.Training in accordance with the stipulations of Table 2 of the Regulations for Administration of Radiation Protection Service Related Business conducted by a radiation protection training provider authorized by the competent authority or conducted by the facility operator.

32.Obtain more than two credits in radiation protection-related courses, as specified in the attachment to the Administrative Regulations for Radiation Protection Personnel, taken at a public or legally registered private college or university in Taiwan, or at a foreign institution recognized by the Ministry of Education.

4Prior to conducting the radiation protection training referred to in Subparagraph 1 of the preceding paragraph, facility operator shall submit the names of trainees, time and place of training, training course and number of hours, and instructor qualifications to the competent authority for reference. Related information shall be recorded and kept on file for at least ten years.

1The radiation safety certificate is valid for six years. Within the six months preceding its expiration, the applicant may submit an application form along with proof of completing at least 36 hours of training or accrued credits during the certificate’s validity period. This documentation shall be provided to the competent authority to request a renewal:

21.radiation protection training conducted by a radiation protection training provider authorized by the competent authority;

32.academic activity or continuing education credits as stipulated in Paragraph 1 of Article 7 of Administrative Regulations for Radiation Protection Personnel; and

43.regular educational training as stipulated in Paragraph 4 of Article 14 of this Act.

5If the radiation safety certificate has expired, the applicant may fill out an application form and attach the documentary proof of above-mentioned training or credits of totaling more than 36 hours in recent 6 years and apply to the competent authority renewedly for a certificate renewal.

1If a radiation safety certificate is lost or damaged during its validity period, the applicant shall submit an application form along with relevant supporting documents to the competent authority to request a replacement.

2For a request to modify information on a valid radiation safety certificate and issue a renewal, an application form shall be filled out, with the relevant documentary proof attached and application made to the competent authority for a certificate renewal.

3For replacements and renewals referred to in the preceding two paragraphs, the period of validity shall be the same as for the original certificate.

1If the holder of a radiation safety certificate has any of the following circumstances, the competent authority may revoke or cancel said certificate:

21.Documents attached to the application for a radiation safety certificate contain false information.

32.The radiation safety certificate has been leased or lent for use to another person.

43.A crime has been committed in the course of business relating to Article 38 or 39 of this Act.

54.Any other situation determined by the competent authority to be a major violation.

6If a radiation safety certificate has been revoked or cancelled by the competent authority, a renewed application shall not be made within one year after the effective date of revocation or cancellation.

1Those who, before the implementation of this Act, have obtained an operating license from the competent authority, or before the implementation of this Act have obtained a formal notification of passing an examination for a non-medical operating license or have obtained a completion certificate for a lecture course in medical ionizing radiation protection, shall within two years of this Act coming into force fill out an application form and attach the original operating license, formal notification of passing an examination for a non-medical operating license or the original of a completion certificate for a lecture course in medical ionizing radiation protection and apply to the competent authority for a replacement of the radiation safety certificate.

2The replaced radiation safety certificate stipulated in the preceding paragraph is valid from the date this Act comes into force.

3Those who have not applied for a replacement within the period stipulated in Paragraph 1 shall fill out an application form and attach the documentary proof of Paragraph 1 and the training and credits received as listed in of Paragraph 1 of Article 7, and apply to the competent authority renewedly for a radiation safety certificate:

41.Those who have not exceeded 4 years from the date of this Act coming into force shall attach the documentary proof of totaling more than 12 hours from the date of this Act coming into force;

52.Those who have exceeded 4 years but less than 6 years from the date of this Act coming into force shall attach the documentary proof of totaling more than 24 hours from the date of this Act coming into force; and

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The format of all the documents and forms stipulated in this Regulations shall be prescribed by the competent authority.

This Regulations shall be put into practice from the date of promulgation.