| Legislative： |
1.Promulgated on January 22, 2003 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu-0920001511
2.Amendment of Article 1, Article 2, Article 4 to Article 6, Article 8, Article 9, Article 13, Article 17, Article 20, Article 22, Article 24, Article 26 to Article 28, Article 30, Article 31, Article 34 to Article 36, Article 41, Article 44, Article 49, Article
50, Article 52, Article 53, Article 55, Article 57 and Appendix on February 23, 2005 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu-0940008702
3.Amendment of Article 4.1, Article 6.1, Article 6.2 and Table on December 29, 2005 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu-0940039736
4.Amendment on October 24, 2007 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu-0960028431
5.Amendment of Article 23, Article 25, Article 27, Article 34, Article 51 and Article 55 on July 11, 2008 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu-0970010549
6.Amendment of Articles 13 and 14 on September 30, 2009 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu 0980016382
7.Amendment of Article 5, Article 17, Article 18, Article 19, Article 23, Article 28, Article 31, Article 42, Article 45, Article 47, Article 47-1 and Article 47-2 and Deletion of Article 57 on January 16, 2012 by the Atomic Energy Council Per its decree No.
Huei-Fu-Tsu-1010000798
8.Amendment of Articles 7 and 46 on December 24, 2012 by the Atomic Energy Council Per its decree No. Huei-Fu-Tsu 1010020806
9.Amendment of Article 2, Article 25, Article 28, Article 31, Article 34, Article 36, Article 41, Article 45, and Article 54 on December 22, 2018 by the Atomic Energy Council Perits decree No. Huei-Fu-Tsu-10700152261 |
| Content： |
Section I General Principles
Article 1
This Regulations is enacted pursuant to the provisions of Paragraph 29.5 of the Ionizing Radiation Protection Act (hereinafter referred to as "this Act").
Article 2
The terms used in this Regulations are defined as follows:
1.Sealed radioactive material refers to radioactive material placed in a sealed container sufficient to provide isolation from the outside under normal use.
2.Unsealed radioactive material refers to radioactive material that does not meet the definition of sealed radioactive material.
3.Modification refers to any one of the following situations involving radioactive material, equipment capable of producing ionizing radiation or the workplace where they are used:
(1) a change in the direction of primary radiation beam of sealed radioactive material or equipment capable of producing ionizing radiation;
(2)an increase in the activity of sealed radioactive material;
(3)an increase in the nominal voltage of an X-ray unit;
(4)an increase in the accelerating voltage of an accelerator;
(5)a change in the radiation protective shielding; or
(6)other situations as designated by the competent authority.
4.Labeling refers to the process of combining a radioactive nuclide with another material to form a radioactive compound.
5.Cabinet refers to a separate cabinet, not a part of a building, originally designed or constructed with appropriate shielding that, when in use, prevents entry by personnel and in which radioactive material or equipment capable of producing ionizing radiation
is placed.
6.High-level radiation facility refers to a facility characterized by one of the following:
(1)equipment capable of producing ionizing radiation with a rated accelerating voltage equal to 30 MV or greater;
(2)equipment capable of producing ionizing radiation with a particle energy rating equal to 30 MeV or greater; or
(3)the use of sealed radioactive material with an activity equal to 1,000 TBq or greater.
7.Transit refers to a stop-over period with definite time parameters for goods not yet unloaded being shipped on the same aircraft or means of transportation that are to enter another country or area via Taiwan air or sea ports.
8.Transshipment refers to a stop-over period with definite time parameters for unloaded goods being shipped on the same or other aircraft or means of transportation that are to enter another country or area via Taiwan air or sea ports.
9.Surface contaminated object (SCO) refers to a solid substance that, itself not radioactive, has been contaminated on the surface by a radioactive material, but this does not include radioactive waste.
Article 3
Sealed radioactive materials are classified into five categories based on their potential hazard to human health and the environment, as listed in Table I.
Section II Application for Permission of Import, Transfer, Export, Transit or Transshipment
Article 4
Paragraph 4.1
Applicants who apply for a permission of import, transfer or export for radioactive material or for equipment capable of producing ionizing radiation shall meet one of the following qualifications:
1.a government agency (institution);
2.a senior high (or vocational) school and above, or academic research institute;
3.a company or other juridical person;
4.a medical institution, medical care radiological clinic or medical examination clinic established with the approval of the public health competent authority;
5.a veterinarian medical institution officially established in accordance with the Veterinarian Act; or
6.other qualifications as approved by the competent authority.
Paragraph 4.2
The applicants who apply for the permission of export referred to in the preceding paragraph shall meet one of the following criteria:
1.possessing a permit or a registration approved by the competent authority for radioactive material or equipment capable of producing ionizing radiation;
2.possessing a permission for production of radioactive material or for manufacture of equipment capable of producing ionizing radiation; or
3.other criteria as designated by the competent authority.
Article 5
Paragraph 5.1
For import of radioactive material or equipment capable of producing ionizing radiation, applicants shall fill out an application form, enclose the following documents and make an application to the competent authority for review and approval, after which the
permission will be granted:
1.results of radiation safety tests done by the original manufacturer, Chinese or English version; and
2.catalogs and explanatory diagrams;
3.for radioactive material, documents relating to the transport details shall also be enclosed.
Paragraph 5.2
The documents in subparagraphs 1 and 2 of the preceding paragraph shall be retained by the applicants themselves, and submission of the documents to the competent authority for review and approval may be waived if the import registration is for equipment capable
of producing ionizing radiation.
Paragraph 5.3
For re-applications for import of radioactive material or equipment capable of producing ionizing radiation of the same model and brand previously reviewed and approved, the submission of all the documents in Paragraph 5.1 may be waived.
Paragraph 5.4
In cases where facility operators possess a permit duly issued by the competent authority or a registration approved by the competent authority to use unsealed radioactive material, the submission of all the documents referred to in Paragraph 5.1 may be waived
at the time of applying for import.
Article 6
Paragraph 6.1
Applicants who apply for import of radioactive material of Column 1 or Column 2 as listed in Table II shall, after obtaining the permission referred to in Article 5, give a photocopy of the said permission to the competent authority of the exporting country
or the exporting organization.
Paragraph 6.2
The applicant shall, seven days before the starting of shipment operation at the port for the sealed radioactive material referred to in the preceding paragraph, specify the following in a written document and inform the competent authority:
1.estimated date of export;
2.name of the exporting organization;
3.name or entire title of the recipient;
4.radionuclide name, quantity, activity and total activity; and
5.unique identifiers such as manufacturer, model and serial number, etc.Paragraph 6.3
When the significant risk sealed radioactive material of Column 1 as listed in Table II reaches the port of destination, the applicant or its designator shall pick up the goods forthwith, and shall not store them in the warehouse of the port without the permission
of the competent authority.
Article 7
Paragraph 7.1
For the transfer of radioactive material or equipment capable of producing ionizing radiation, assignors and assignees shall jointly fill out an application form and apply to the competent authority for review and approval, after which permission may be granted.
Paragraph 7.2
For the applications of transfer of radioactive material referred to in the preceding paragraph, documents relating to the transport details shall also be enclosed.
Paragraph 7.3
In cases where facility operators possess a permit duly issued by the competent authority or registration approved by the competent authority for the use of unsealed radioactive material, the enclosure of the documents referred to in the preceding paragraph
may be waived when applying for the transfer of unsealed radioactive material.
Article 8
Paragraph 8.1
For export of radioactive material or equipment capable of producing ionizing radiation, applicants shall fill out an application form and make an application to the competent authority for review and approval, after which the permission will be granted.
Paragraph 8.2
For the applications of the export of radioactive material referred to in the preceding paragraph, documents relating to the transport details shall also be enclosed.
Article 9
Paragraph 9.1
Applicants who apply for export of significant risk sealed radioactive material of Column 1 as listed in Table II shall, in addition to the documents stipulated in the preceding Article, enclose the import agreement documentation from the competent authority
of the importing country and send it to the competent authority for review.
Paragraph 9.2
The import agreement documentation referred to in the preceding paragraph shall specify the following:
1.name or entire title of the recipient;
2.recipient's residence, firm or principal place of business;
3.radionuclide name, quantity, activity and total activity;
4.unique identifiers such as manufacturer, model and serial number, etc; and
5.estimated starting and ending time of shipment.
Article 10
Applicants for export of significant risk sealed radioactive material of Column 1 or Column 2 as listed in Table II shall, seven days before the starting of shipment operation at the port for the sealed radioactive material, specify in a written document the
following and inform the competent authority and the competent authority as well as the recipient of the importing country:
1.estimated date of export;
2.name or entire title of the applicant;
3.name or entire title of the recipient;
4.radionuclide name, quantity, activity and total activity; and
5.unique identifiers such as manufacturer, model and serial number, etc.
Article 11
Paragraph 11.1
Applicants who apply for a permission to import or export a surface contaminated object shall possess one of the following qualifications:
1.a government agency (institution);
2.a university, college or academic research institute;
3.a company or other juridical person;
4.a medical institution set up with the official approval of the competent health authority; or
5.other qualifications as approved by the competent authority.
Paragraph 11.2
Applications for import or export of surface contaminated objects shall conform with the Regulations for the Safe Transport of Radioactive Material.
Article 12
For import or export of surface contaminated objects, the following documents shall be enclosed and an application shall be made to the competent authority for review and approval, after which the permission will be granted:
1.data on the package or packaging smear test and surface dose rates;
2.documents relating to the transport details.
Article 13
Paragraph 13.1
For transit or transshipment of radioactive material, the shipper or the carrier shall enclose the radiation protection plan and make an application to the competent authority for review and approval, after which the permission will be granted. The permission
is effective for a period of five years.
Paragraph 13.2
The shipper or the carrier having obtained the permission shall enclose the transport documents to the competent authority for filing and reference prior to transit or transshipment of any batch of radioactive material.
Paragraph 13.3
Transit or transshipment of radioactive material shall comply with the Regulations for the Safe Transport of Radioactive Material.
Paragraph 13.4
In cases of transport of radioactive material in excepted packages, the stipulations in the first and the second paragraph do not apply.
Article 14
The permission of import, transfer, or export is effective for a period of six months.
Section III Applications for a Permission, a Permit or a Registration for Use, Installation, Modification or Possession
Article 15
Paragraph 15.1
Applicants who apply for a permit or a registration for the use of radioactive material or equipment capable of producing ionizing radiation shall possess one of the following qualifications:
1.a government agency (institution);
2.a senior high (or vocational) school and above, or academic research institute;
3.a company or other juridical person;
4.a medical institution, medical care radiological clinic or medical examination clinic established with the official approval of the public health competent authority;
5.a veterinarian medical institution officially established in accordance with the Veterinarian Act; or
6.other qualifications as approved by the competent authority.
Paragraph 15.2
In the case of an application for the use referred to in the preceding paragraph, the applicants shall meet the following criteria:
1.having qualified operating personnel;
2.possessing a workplace or storage area meeting radiation safety regulations; and
3.other criteria as designated by the competent authority.
Article 16
Paragraph 16.1
For use of the following radioactive material, a registration application shall be made to the competent authority for filing and reference:
1.sealed radioactive material of Category IV and Category V as listed in Table I;
2.radioactive material that forms a component of an instrument or manufactured product and that has an activity less than 1,000 times that of the exemption level and that under normal usage has a surface dose rate at an accessible distance of 5 cm of less than
5 microsieverts (μSv) per hour;
3.radioactive material other than those referred to in the preceding two subparagraphs with an activity less than 100 times that of the exemption level; or
4.other radioactive material as designated by the competent authority.
Paragraph 16.2
For use of radioactive material other than those stipulated in the preceding paragraph, an application for a permit shall be made to the competent authority.
Article 17
Paragraph 17.1
For use of the following equipment capable of producing ionizing radiation, applicants shall apply for a registration to the competent authority:
1.nominal voltage is less than 150 kV or particle energy is less than 150 keV;
2.cabinet or baggage inspection X-ray machine, ion implanter, electron beam welding machine or static eliminator that under normal usage has a surface dose rate at an accessible distance of 5 cm of less than 5 microsieverts (μSv) per hour; or
3.other equipment as designated by the competent authority.
Paragraph 17.2
For use of equipment capable of producing ionizing radiation other than those stipulated in the preceding paragraph or for non-medical use of those stipulated in subparagraph 1 of the preceding paragraph with direct irradiation on human bodies, an application
for a permit shall be made to the competent authority. The permission of import, transfer, or export is effective for a period of six months.
Article 18
Paragraph 18.1
Applicants for use of sealed radioactive material or equipment capable of producing ionizing radiation for which a permission application shall be made shall, when applying for import or transfer, fill out an application form, enclose the following documents
and make an application to the competent authority for review. In cases that shield engineering is involved in the installation, the installation permission will be granted after review and approval; in cases that shield engineering is not involved in the
installation, following the grant of permission by the competent authority for import or transfer, the documents referred to in Paragraph 18.2 shall be enclosed to the competent authority for review, inspection and approval, after which the permit for use
will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (institution);
2.photocopies of the relevant operating personnel credentials and the certificates of employment;
3.workplace radiation safety assessment. In cases that shield engineering is not involved, a shielding planning need not to be enclosed;
4.a radiation protection plan and radiation safety operation guidelines;
5.photocopies of the certificates of radiation protection personnel shall be submitted in conformity with the stipulations in the Standards for Establishment of Radiation Protection Management Organizations and Radiation Protection Personnel; and
6.for use of sealed radioactive material of Category I or Category II as listed in Table I, a security planning shall be submitted.
Paragraph 18.2
Only after the applicants referred to in the preceding paragraph have obtained the installation permission can installation begin in accordance with the officially approved workplace radiation safety assessment, the floor plans and the shielding planning. Within
30 days after completion of the installation, the following documents are to be enclosed to the Competent Authority for review, inspection and approval, after which the permit for use will be issued:
1.a radiation safety survey report (hereinafter referred to as "survey report");
2.for sealed radioactive material conforming with the stipulations referred to in Paragraph 54.1, a sealed radioactive material smear test report shall be submitted (hereinafter referred to as "smear test report"); and
3.for sealed radioactive material, a photocopy of the original certification document of radioactive material shall be submitted.
Article 19
Paragraph 19.1
For unsealed radioactive material or re-packaged and labeled radioactive material whose use requires a permission, applicants shall fill out an application form, enclose the following documents and make an application to the competent authority for review and
approval, after which the installation permission will be granted:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (institution);
2.photocopies of the relevant operating personnel credentials and the certificates of employment;
3.workplace radiation safety assessment;
4.a radiation protection plan and radiation safety operation guidelines;
5.for the labeling of radioactive material, information on the physical and chemical properties of the radioactive material as well as on the handling process used shall be submitted; and
6.in conformity with the stipulations in the Standards for Establishment of Radiation Protection Management Organizations and Radiation Protection Personnel, photocopies of the certificates of radiation protection personnel shall be enclosed.
Paragraph 19.2
Only after the applicants referred to in the preceding paragraph have obtained the installation permission can the shield engineering installation begin in accordance with the officially approved workplace radiation safety assessment. Within 30 days after completion
of the installation, a radiation safety survey report is to be enclosed to the competent authority for review, inspection and approval, after which the permit for use will be issued.
Article 20
The workplace radiation safety assessments referred to in Subparagraph 18.1.3 and Subparagraph 19.1.3 shall deliberate the following items for appropriate assessing, in accordance with the scale and nature of the radiation practice:
1.workplace floor plans and shielding planning;
2.measures for handling radioactive contaminants;
3.protective measures on mobile radioactive material or equipment capable of producing ionizing radiation; and
4.personnel dose assessment.
Article 21
The permit for use is effective for a maximum period of five years. Facility operators shall fill out an application form 60 to 30 days before the expiration date and enclose the following documents to the competent authority for review, inspection and approval,
after which renewal of the permit for use will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (institution);
2.the original permit for use;
3.a survey report done within the last 30 days; and
4.for sealed radioactive materials conforming with the stipulations referred to in Paragraph 54.1, the latest smear test report shall also be enclosed.
Article 22
Paragraph 22.1
Facility operators who have obtained the permit for use of radioactive material or equipment capable of producing ionizing radiation shall fill out an application form before making modifications and enclose the following documents to the competent authority
for review and approval, after which the modification permission will be granted:
1.workplace radiation safety assessment in accordance with the stipulations of Article 20.;
2.photocopies of the relevant operating personnel credentials; and
3.the original permit for use.
Paragraph 22.2
In cases where the modification referred to in the preceding paragraph involves a change in radiation safety, a radiation protection plan or radiation safety operating guidelines shall be enclosed.
Paragraph 22.3
Only after the facility operator obtains the modification permission may the modification proceed in accordance with the approved workplace radiation safety assessment. Within 30 days after completion of the modification, the following documents shall be enclosed
to the competent authority for review, inspection and approval, after which the permit for use will be issued:
1.a survey report; and
2.for sealed radioactive material in conformity with the stipulations referred to in Paragraph 54.1, a smear test report shall be submitted.
Article 23
Paragraph 23.1
For use of sealed radioactive material that requires a registration approved by the competent authority, applicants shall, when applying for import or transfer, fill out an application form, enclose the following documents and make an application to the competent
authority for review. If shield engineering is involved in the installation, the installation permission will be granted after review and approval; if shield engineering is not involved in the installation, after the competent authority grants the permission
of import or transfer, the documents referred to in Paragraph 23.2 are to be enclosed to the competent authority for review and approval, after which the registration will be approved:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (institution);
2.photocopies of the relevant operating personnel credentials and the certificates of employment;
3.workplace floor plans and shielding planning; the shielding planning may be waived if shield engineering is not involved or Subparagraph 16.1.2 is qualified; and
4.a radiation protection plan.
Paragraph 23.2
Only after the applicants referred to in the preceding paragraph have obtained the installation permission may the installation proceed in accordance with the approved workplace floor plans and shielding planning. Within 30 days after completion of the installation,
the following documents shall be enclosed to the competent authority for review and approval, after which the registration will be approved:
1.a photocopy of the original radioactive material certification;
2.a survey report; and
3.for sealed radioactive material in conformity with the stipulations referred to in Paragraph 54.1, a smear test report shall be submitted.
Paragraph 23.3
For use of equipment capable of producing ionizing radiation that requires a registration approved by the competent authority, applicants shall fill out an application form within 30 days after completion of the installation, enclose the following documents
and make an application to the competent authority for review prior to the use of the equipment, after which a registration will be approved:
1.name and certificate number of the certification of establishment or the registration approved;
2.name and certificate number of the relevant operating personnel credentials;
3.survey report related information; and
4.a radiation protection plan.
Article 24
For unsealed radioactive material or re-packaged, labeled radioactive material, whose use requires a registration, applicants shall fill out an application form, enclose the following documents and make an application to the competent authority for review and
approval, after which a registration will be approved:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (or institution);
2.photocopies of the relevant operating personnel credentials and the certificate of employment;
3.workplace floor plans and shielding planning;
4.a radiation protection plan; and
5.for the labeling of radioactive material, information on the physical and chemical properties of the radioactive material as well as on the handling process used shall be submitted.
Article 25
Once every five years, the facility operators who have the registration approved by the competent authority for radioactive material or equipment capable of producing ionizing radiation three months prior to or after the month equivalent to the approved registration
month, shall conduct a radiation safety survey and record the results for filing and reference.
Article 26
Paragraph 26.1
When the radioactive material for which the registration has been approved is to be modified, the facility operators shall fill out an application form before modification and enclose the following documents to the competent authority for review and approval,
after which a modification permission will be issued:
1.workplace floor plans and shielding planning; and
2.photocopies of the relevant operating personnel credentials; and
3.the original registration for use
Paragraph 26.2
Only after the facility operators have obtained the modification permission may the modification work proceed in accordance with the approved workplace floor plans and shielding planning. Within 30 days after the work is completed, the following documents shall
be enclosed to the competent authority for review, after which a registration will be approved:
1.survey report; and
2.for sealed radioactive material in conformity with the stipulations referred to in Paragraph 54.1, a smear test report shall be submitted.
Paragraph 26.3
The facility operators who have the registration approved by the competent authority for equipment capable of producing ionizing radiation shall, within 30 days after the modification work is completed, fill out an application form and the following information,
enclosed to the competent authority for review and approval, after which a registration will be approved:
1.name and certificate number of the relevant operating personnel credentials.
2.survey report related information and radiation detection data.
Paragraph 26.4
If, after modification, the energy level of the equipment capable of producing ionizing radiation or the total activity of the radioactive material reaches the level stipulated that the permit shall be applied for, then matters shall proceed in accordance with
the stipulations referred to in Article 22.
Article 27
Paragraph 27.1
For radioactive material or equipment capable of producing ionizing radiation, ifthere will be a movement to a new location or a change of the workplace and therefore an installation or modification is involved, the facility operators shall fill out an application
form and apply for a permit for use or a registration separately in accordance with the installation or modification stipulations referred to in Article 18, Article 22 and Article 23.
Paragraph 27.2
If the facility operators, who have obtained the permit or the registration approved by the competent authority for the use of unsealed radioactive material, will increase the number of workplaces, the number of nuclides or activity used, they shall apply for
a permit for use or a registration separately in accordance with the stipulations referred to in Article 19 and Article 24.
Article 28
Paragraph 28.1
For use of a high-level radiation facility, applicants shall fill out an application form and enclose the following documents to the competent authority for review and approval, after which a permission for installation will be issued:
1.a photocopy of the certification of
establishment or the registration approved; waived for government agencies (institution);
2.workplace radiation safety assessment;
3.radiation protection plan and radiation safety operation guidelines;
4.the structure of workplace shielding and machinery and an seismic resilience certification;
5.operational training and practical operational training plan;
6.schedule plan of a trial operation ;
7.for sealed radioactive material, a photocopy of the original radioactive material certification and security planning shall be enclosed; and
8.procedure for dealing with accidents.
Paragraph 28.2
The workplace radiation safety assessment referred to subparagraph 2 of the preceding paragraph shall contain the following information:
1.workplace floor plans and shielding planning;
2.facility radiation dose assessment and protection measures;
3.measures for handling radioactive contaminants (including activated products); and
4.other information as designated by the competent authority.
Paragraph 28.3
Only after the applicants have obtained the permission for installation may the work proceed in accordance with the approved radiation safety assessment, the floor plans, and the shielding planning. Within 30 days after completion of the work, a trial operation
plan shall be enclosed to the competent authority for review, inspection and approval, after which a trial operation permission will be issued.
Paragraph 28.4
After the completion of the trial operation the applicants shall enclose, within 30 days, a trial operation report to the competent authority for review, inspection and approval, after which a permit for use will be issued.
Paragraph 28.5
The trial operation report referred to in the preceding paragraph shall include the following items:
1.the area monitoring results;
2.the personnel dose monitoring results;
3.the record of the trial operation; and
4.other items as designated by the competent authority.
Article 29
The permit for use of a high-level radiation facility is effective for a maximum period of five years. The facility operators shall fill out an application form 60 to 30 days before the expiration date and enclose the following documents to the competent authority
for review, inspection and approval, after which a renewed permit for use will be issued:
1.a photocopy of the certification of establishment or the registration approved; waived for government agencies (institution); and
2.the survey report done within the last 30 days.
Article 30
For installation or modification of radioactive material or equipment capable of producing ionizing radiation, the work shall be completed within the time frames as specified below. If the work is not completed within the specified time frame, an application
for extension may be made to the competent authority one month prior to the deadline:
1.a high-level radiation facility shall be completed within two years of the approved installation or modification date.
2.work involving the use of radioactive material other than that referred to in the preceding subparagraph or equipment capable of producing ionizing radiation to which the permission shall be applied, shall be completed within one year of the approved installation
or modification date.
3.work involving the use of equipment capable of producing ionizing radiation to which the registration is to be applied shall be completed within one year of the approved import or transfer date.
Article 31
Paragraph 31.1
Those who are engaged in radiation protection service businesses shall not possess radioactive material. However, the following circumstances with the permission of the competent authority are excluded:
1.those who sale sealed radioactive material referred to in Paragraph 16.1;
2.those who are engaged in sales service businesses or radiation protection detection businesses replace sealed radioactive material for facility operators and execute temporary storage of the material before export or transfer; or
3. those who are engaged in sales service businesses or radiation protection detection businesses execute temporary storage of unsealed radioactive material during transportation.
Paragraph 31.2
Applicants who apply for possession of radioactive material according to the stipulations in the preceding paragraph shall fill out an application form, enclose the following documents and make an application to the competent authority for review, inspection
and approval, after which a possession permission will be issued:
1.the permit of radiation protection service businesses;
2.application documentation on the brand, model, nuclide, activity and quantity of the radioactive material for possession;
3.radiation protection plan; and
4.radiation safety assessment on an appropriate storage area and shielding planning. They shall be conducted according to the maximum holding of the radioactive material estimated for the appropriate storage area.
Paragraph 31.3
Those who are permitted by the competent authority to engage in the sales of equipment capable of producing ionizing radiation may possess the equipment capable of producing ionizing radiation according to the approved items.
Article 32
Paragraph 32.1
For any of the following situations, the applicants shall apply for a possession permission:
1.inability to complete the installation or the modification within the time frame stipulated in Article 30;
2.subsequent to the approval by the competent authority for import or transfer, inability to proceed the installation following the delivery; or
3.other situations as approved by the competent authority.
Paragraph 32.2
The applicants shall, 30 days prior to the deadline stipulated in Article 30 or within 30 days from the delivery of the radioactive material or the equipment capable of producing ionizing radiation, enclose the following documents and make an application to
the competent authority for review. After the equipment capable of producing ionizing radiation is reviewed and approved, a possession permission will be issued; after the radioactive material is reviewed, inspected and approved, a possession permission will
be issued:
1.reasons for possession;
2.radiation protection plan;
3.the storage area. For radioactive material, the floor plans and the shielding planning shall be submitted; and
4.for sealed radioactive material in conformity with the stipulations of Paragraph 54.1, a smear test report shall be submitted.
Paragraph 32.3
The possession permission referred to in Paragraph 32.2 is effective for a maximum of two years.
Paragraph 32.4
The facility operator may, within 60 to 30 days prior to the expiration of the possession permission of the radioactive material or the equipment capable of producing ionizing radiation, fill out an application form and enclose all the documents provided in
the preceding paragraph to the competent authority for extension, which is subject to a maximum of one time.
Article 33
Paragraph 33.1
For the permit for radioactive material or equipment capable of producing ionizing radiation or the designated items in the registration approved by the competent authority, if there is change of the printed items or loss or damage of the permit, the facility
operator shall, within 30 days of the occurrence, fill out an application form and apply to the competent authority for change, reissuance or renewal.
Paragraph 33.2
The period of effectiveness for the permit is the same as that for the original one.
Article 34
Paragraph 34.1
When a facility operator replaces the X-ray tube or the accelerator tube of equipment capable of producing ionizing radiation, the operator shall proceed according to the following stipulations. However, the following stipulations are not applicable to the
replacement of the X-ray tube of static eliminators:
1.for that who obtains the permit for use, a survey report shall be enclosed to the competent authority for filing and reference within 15 days after the replacement.
2.for the registration approved by the competent authority, the survey report shall be retained by the facility operator.
Paragraph 34.2
If a facility operator removes and replaces radioactive material for which he/she possesses the permit for use or the registration approved by the competent authority, he/she shall fill out an application form and enclose the following documents prior to effecting
the replacement, and submit to the competent authority for review; and within 30 days following the replacement, he/she shall enclose a smear test report and a photocopy of the original certification documentation of the newly installed radioactive material
to the competent authority for filing and reference:
1.the documents relating to the transport details; and
2.method of processing the original radioactive material after the replacement.
Paragraph 34.3
For the replacement of radioactive material provided in the preceding paragraph, if the container is replaced at the same time, the application shall be filed in accordance with the stipulations set forth in Article 18 and Article 23 before the replacement.
Section IV Application for a Permission for Temporary or Permanent Cease of Use
Article 35
Paragraph 35.1
In cases where the use of radioactive material or equipment capable of producing ionizing radiation shall be ceased, the facility operator shall fill out an application form, enclose the following documents and make an application to the competent authority
for review. After the equipment capable of producing ionizing radiation is reviewed and approved, a permission for cease of use will be granted; after the radioactive material is reviewed, inspected and approved, the permission for cease of use will be granted:
1.the original permit for use, for those who have already obtained it; and
2.description of the storage area. For radioactive material, a floor plan of the storage area and the shielding planning shall be enclosed.
Paragraph 35.2
The permission referred to in the preceding paragraph are effective for a maximum period of two years.
Paragraph 35.3
The facility operator may, within 60 to 30 days prior to the expiration of ceased use of the radioactive material or the equipment capable of producing ionizing radiation, fill out an application form and enclose all the documents provided in Subparagraph 35.1.2
to the competent authority for extension.
Article 36
Paragraph 36.1
In cases where an application is made to resume the use of the radioactive material or the equipment capable of producing ionizing radiation that has previously obtained the approval for cease of use, the procedure shall comply with the stipulations of Articles
18, 19, 23, 24, or 28; however, an application for an installation permit may be waived if the use is to take place at the location originally approved by the competent authority.
Paragraph 36.2
If the reason for the approved cease of use referred to in the preceding paragraph is the lack of qualified operating personnel, the facility operator shall, when making an application for the resumption of use, fill out an application form, attach qualified
operating personnel credentials, and make an application to the competent authority for review and approval, after which the permit for use will be issued or the registration will be approved.
Article 37
Paragraph 37.1
When a facility operator permanently ceases the use of radioactive material and disposes of it as radioactive waste, the operator shall fill out an application form, enclose the following documents and make an application to the competent authority for review
and approval, after which the permission will be granted:
1.discard plan of sealed radioactive material;
2.a photocopy of the originally certification documents of the radioactive material; and
3.documents relating to the transport details.
Paragraph 37.2
Following the approval of the application referred to in the preceding paragraph by the competent authority, the facility operator shall, within three months, transport the radioactive waste to the receiving unit. Within 30 days of receipt of the said material,
a radiation workplace monitoring certificate, receipt documentation and the original permit for use for those who have already obtained it shall be enclosed and submitted to the competent authority for filing and reference.
Article 38
Paragraph 38.1
When a facility operator permanently ceases the use of radioactive material or equipment capable of producing ionizing radiation and disposes of it by shipping overseas, the operator shall fill out an application form, submit the documents relating to the transport
details in the case of exporting radioactive material and make an application to the competent authority for review and approval, after which the permission will be granted.
Paragraph 38.2
After the application referred to in the preceding paragraph is approved by the competent authority, the facility operator shall, within 30 days after exportation, enclose a photocopy of the export documentations, the original permit for use for those who have
already obtained it, and the radiation workplace monitoring certificate in the case of exporting radioactive material, and submit to the competent authority for filing and reference.
Article 39
Paragraph 39.1
When a facility operator permanently ceases the use of equipment capable of producing ionizing radiation and disposes of it by transfer, the assignee shall proceed as follows:
1.for equipment capable of producing ionizing radiation designated as requiring an application for a permission, the operator shall proceed in accordance with the stipulations of Articles 7 and 18.
2.for equipment capable of producing ionizing radiation designated as requiring an application for registration, the operator shall proceed in accordance with the stipulations of Articles 7 and 23.
Paragraph 39.2
If the assignee referred to in the preceding paragraph applies for possession, the assignee shall proceed in accordance with the stipulations of Articles 7 and 32.
Article 40
When a facility operator permanently ceases the use of equipment capable of producing ionizing radiation and disposes of it by discard, the operator shall fill out an application form, enclose the original permit for use for those who have already obtained
it and make an application to the competent authority for review and approval, after which he/she will independently render inoperable such parts of said equipment as designated by the competent authority and will either take a photograph for filing and reference
or report to the competent authority for inspection.
Article 41
Paragraph 41.1
When a facility operator permanently ceases the use of unsealed radioactive material workplace, the operator shall fill out an application form, enclose the following documents and make an application to the competent authority for review and approval, after
which he/she shall process the decontamination in accordance with the approved plan:
1.the original permit for use for those who have already obtained it; and
2.decontamination plan.
Paragraph 41.2
The decontamination plan referred to in subparagraph 2 of the preceding paragraph shall include decontamination schedule, decontamination method, treatment for radioactive waste, division of the decontamination area and measures for personnel control.
Paragraph 41.3
Following completion of the decontamination process, the facility operator shall enclose a radiation workplace monitoring certificate, and report to the competent authority for inspection.
Section V Application for a Permission for Display or Lease
Article 42
Paragraph 42.1
Applicants who apply for a permission for display of radioactive material or equipment capable of producing ionizing radiation shall meet one of the following criteria:
1.applicants shall be a business representative recognized by the competent authority to engage in sales service of radioactive material or equipment capable of producing ionizing radiation;
2.applicants shall possess the permission for manufacturing of equipment capable of producing ionizing radiation, issued according to the stipulations in Paragraph 30.1of this Act; or
3.other applicants approved by the competent authority.
Paragraph 42.2
The period of display referred to in the preceding paragraph shall not exceed two months.
Article 43
For a static display of equipment capable of producing ionizing radiation, applicants shall enclose the following documents and make an application to the competent authority for review and approval, after which the permission will be granted:
1.catalogs and explanatory diagrams; and
2.display plan and schedule.
Article 44
Paragraph 44.1
For the following radioactive material or equipment capable of producing ionizing radiation, an application may be made for dynamic display:
1.radioactive material provided in Subparagraph 16.1.1 that forms a component of an instrument or manufactured product;
2.radioactive material provided in Subparagraph 16.1.2;
3.equipment capable of producing ionizing radiation provided in Subparagraphs 17.1.1 and 17.1.2; or
4.others as designated by the competent authority.
Paragraph 44.2
For the display referred to in the preceding paragraph, the applicant shall enclose the following documents and make an application to the competent authority for review and approval, after which the permission will be granted:
1.catalogs, explanatory diagrams and information regarding radiation safety;
2.radiation protection plan;
3.photocopies of credentials of relevant qualified operating personnel; and
4.display plan and schedule.
Article 45
Paragraph 45.1
Applicants who apply for a lease permission for radioactive material or equipment capable of producing ionizing radiation shall possess one of the following qualifications:
1.government agency (institution);
2.university, college or academic research institute;
3.company or other juridical person;
4.a medical institution, medical care radiological clinic or medical examination clinic;
5.a veterinary medical institution; or
6.other qualifications as approved by the competent authority.
Paragraph 45.2
For the application for a lease referred to in the preceding paragraph, the following criteria shall be met:
1.the lessee or the borrower has qualified operating personnel or the personnel are provided by the lessor or the lender;
2.the applicant possesses an appropriate workplace or storage area; and
3.radioactive material or equipment capable of producing ionizing radiation shall be mobile, cabinet-mounted, vehicle-mounted or the radioactive material used for calibration purposes.
Paragraph 45.3
In cases where the vehicle-mounted equipment capable of producing ionizing radiation referred to in subparagraph 3 of the previous paragraph is for medical purposes, the requirement to apply for a lease permission may be waived upon announcement by the competent
authority.
Article 46
Paragraph 46.1
In an application for leasing radioactive material or equipment capable of producing ionizing radiation, the lessee or the borrower shall explain the reasons for leasing, enclose the following documents and make an application to the competent authority for
review and approval, after which the permission will be granted:
1.a photocopy of the original permit for those who have already obtained it;
2.the lease contract specifying the proposed period of lease;
3.a workplace radiation safety assessment carried out in accordance with Article 20. For registration of radioactive material or equipment capable of producing ionizing radiation to be applied, the said assessment may be waived;
4.radiation protection plan and radiation safety operation guidelines;
5.a photocopy of certification of establishment or registration approved; waived for government agencies (institution); and
6.photocopies of relevant qualified operating personnel credentials and certificate of employment.
Paragraph 46.2
The duration of the lease permission referred to in the preceding paragraph is up to two years. When the lease period is over, the lessee or the borrower shall immediately return the material or the equipment to the lessor or the lender and shall, within one
month, enclose a survey report and submit to the competent authority for filing and reference. For the sealed radioactive material conforming with the stipulation of Paragraph 54.1, a smear test report shall be submitted.
Section VI Controls
Article 47
The workplace and the shielding planning for radioactive material or equipment capable of producing ionizing radiation shall be made in accordance with its scale and nature, and refer to the stipulations set forth in Appendix I.
Article 47-1
Paragraph 47-1.1
For the security planning for sealed radioactive material of Category I or Category II, its contents shall refer to the matters stipulated in Appendix 2.
Paragraph 47-1.2
The security level and functions of sealed radioactive material of Category I or Category II shall be in accordance with the stipulations set forth in Table 3.
Article 47-2
Prior to the implementation of the security plans for Category I or Category II sealed radioactive materials, if existing Category I or Category II sealed radioactive materials or permitted radiation practices are not in compliance with the provisions set forth
in preceding Article, improvements shall be completed within one year from 16 January 2012, the effective date of the amended Regulations. However, extensions may be granted with the approval of the competent authority, limited to one year.
Article 48
If the practice of radioactive material or equipment capable of producing ionizing radiation has one of following conditions, the competent authority may revoke its permission, permit or registration:
1.the competent authority ordered the suspension of all its practices twice within one year; or ordered to suspend part of its practices three times in one year; or
2.the competent authority recognizes that there is concern about radiation safety of radioactive material or equipment capable of producing ionizing radiation, which may be detrimental to human health, safety or environmental ecology and that the situation
can never be improved, the material or the equipment can never be used, or the situation cannot be improved within a prescribed time for over half a year.
Article 49
The radiation safety survey for radioactive material or equipment capable of producing ionizing radiation and the smear test for sealed radioactive material shall be conducted by a radiation protection detection service provider authorized by the competent
authority or radiation protection personnel designated by the facility operator.
Article 50
A facility operator using unsealed radioactive material shall conduct a contamination survey of the workplace once per week or after each operation and maintain records. At least twice a year, samples of discharged wastewater shall be collected and analyzed
for radionuclides.
Article 51
For radioactive materials or equipment capable of producing ionizing radiation as specified in the following documents, the facility operator shall verify the inventory account and usage status every six months, record the findings, and retain the records for
future reference:
1.the permit for use or the permission for possession of radioactive material, and the registration approved by the competent authority.
2.the permit for use or the permission for possession of equipment capable of producing ionizing radiation.
Article 52
Paragraph 52.1
A facility operator who uses, ceases to use or possesses sealed radioactive material shall report to the competent authority within the first 15 days of each month on the status of use, cease of use or possession in the preceding month with regard to the said
material.
Paragraph 52.2
The report referred to in the preceding paragraph may be filed via the Internet.
Article 53
After permission for the import of radioactive material has been granted by the competent authority, the applicant shall, upon arrival of the material, confirm the integrity of the packaging and the package surface, measure the surface dose rate, conduct a
smear test and make a record of them. However, the above requirement does not apply to the radioactive material with an activity or an activity concentration less than 100 times the exemption level, excepted packages, or the radioactive material that itself
is a noble gas.
Article 54
Paragraph 54.1
If a facility operator uses, ceases to use, or possesses a sealed radioactive material, the operator shall conduct a sealed radioactive material smear test within the time period prescribed in Paragraph 54.3 and retain a record for filing and reference. However
the following sealed radioactive material may be waived for the smear test:
1.sealed radioactive material used for calibration in a liquid scintillation counter;
2.sealed gaseous radioactive material;
3.sealed radioactive material with a half-life of not exceeding 30 days;
4.beta- or gamma-emitting radioactive nuclide with an activity of not exceeding 3.7
MBq;
5.alpha-emitting radioactive nuclide with an activity of not exceeding 370 kBq; and
6.other materials as designated by the competent authority.
Paragraph 54.2
If the radioactive nuclide referred to in the preceding paragraph is radium, the smear test shall include a test for radon leakage.
Paragraph 54.3
Smear test reports of sealed radioactive material shall be made by the facility operator according to the timeframes prescribed below:
1.once every six months for sealed radioactive material in teletherapy equipment and remote after-loading brachytherapy equipment;
2.once a year for sealed radioactive material of other uses;
3.once every three years for americium-241 or nickel-63 contained in toxic gas detectors; or
4.other actions announced by the competent authority shall be completed according to the prescribed timeframes.
Paragraph 54.4
If the smear test results referred to in Paragraph 54.1 exceed 185 Bq, the facility operator shall cease the uses immediately and report to the competent authority within seven days.
Article 55
The stipulated radiation survey report, smear test report, monitoring records of liquid waste samples, measuring records of workplace and periodic check records shall all be retained for five years.
Section VII Supplementary Provisions
Article 56
Applying for or renewing various permission, permits, or registration in conformity with this Regulations, the documents for review or the information to be filled out that the applicant shall enclose may, besides those have been stipulated in this Regulations,
be designated and announced by the competent authority as needed.
Article 57
(Deleted)
Article 58
The format for all the documents and the forms stipulated in this Regulations shall be prescribed by the competent authority.
Article 59
This Regulations shall be put into practice from the date of promulgation.
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