Section I General Principles Article 1 The Regulations are prescribed in accordance with the provisions of
Article 29, Paragraph 5 of the Ionizing Radiation Protection Act
(hereinafter referred to as “this Act”).
Article 2 The definitions for terms used in the Regulations are as follows:
1. Sealed radioactive material: radioactive material placed in a
sealed container sufficient to provide isolation from the
outside under normal use. 2. Modification: any one of the following situations involving
radioactive material, equipment capable of producing ionizing
radiation or the workplace: (1) A change in the direction of the primary radiation beam of
the sealed radioactive material or equipment capable of
producing ionizing radiation. (2) An increase in the activity of the sealed radioactive
material. (3) An increase of the nominal voltage in the X-ray unit. (4) An increase in the accelerating voltage of the accelerator. (5) A change in the radiation protective shielding. (6) Other situations as designated by the competent authority. 3. Labeling: The process of combining a radioactive nuclide with
another material to form a radioactive compound. 4. Cabinet: A separate cabinet, not a part of the 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. 5. High-level radiation facility: a facility characterized by one
of the following: (1) Equipment capable of producing ionizing radiation with a
rated accelerating voltage of greater than 30 MV. (2) Equipment capable of producing ionizing radiation with a
particle energy rating of greater than 30 MeV. (3) The use of sealed radioactive material with a activity of
greater than 1,000 TBq. 6. Transit: 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 county or
area via Taiwan air or sea ports. 7. Transshipment en route: A stop-over period with definite time
parameters for unloaded goods being shipped on the same
aircraft or other means of transportation that are to enter
another county or area via Taiwan air or sea ports. 8. Surface contaminated object (SCO): 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 There are five types of sealed radioactive materials categorized by
their degree of potential detriment against human health and
environment as listed in Table I of the Appendix.
Section II Application for a Permit for Import, Transfer, Export,
Transit or Transshipment En Route Article 4 Applicants for the import, transfer, and export of radioactive
material or equipment capable of producing ionizing radiation shall
possess one of the following qualifications: 1. Government agency (or organization). 2. Post-secondary high (or vocational) school or academic
research organization. 3. Company or other legal person. 4. Medical institution, radiology center or medical laboratory
established with the approval of the public health competent
authority. 5. Veterinarian medical institutions officially established in
accordance with the Law Governing Veterinarian. 6. Other qualifications as approved by the competent authority. Applicants for export permits referred to in the preceding paragraph
shall meet one of the following criteria: 1. Possess a certificate of permission or registration approved by
the competent authority for radioactive material or equipment
capable of producing ionizing radiation. 2. Possess a permit for the production of radioactive material or
a permit for the manufacture of equipment capable of
producing ionizing radiation. 3. Other criteria as designated by the competent authority. Article 5 For the importation of radioactive material or equipment capable of
producing ionizing radiation, applicants shall fill out an
application form, attach the following documents and make
application to the competent authority for review and approval, after which the permit will be issued. However, they are waived for
equipment capable of producing ionizing radiation if registration
for filing and reference shall be applied: 1. Results of radiation safety tests done by original
manufacturer, Chinese or English version. 2. Catalog and explanatory diagrams. 3. For radioactive material, documents relating to the transport
details shall also be enclosed. For re-applications for the importation of radioactive material or
equipment capable of producing ionizing radiation of the same model
and brand previously reviewed and approved, the submission of all
documents in the preceding paragraph may be waived. In cases where facility operators possess a certificate of
permission duly issued by the competent authority or registration
approved by the competent authority to use non-sealed radioactive
material, the submission of all documents referred to in Paragraph 1
may be waived at the time of application for importation.
Article 6 Applicants for the import of radioactive material of Column 1 or
Column 2 as listed in Table II of the Appendix shall, after
obtaining the permit referred to in the preceding Article, give a
photocopy of said permit to the competent authorities of the
exporting country or the exporting organization.
The applicant shall, seven days before the starting of the 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 of the: 1. Estimated date of export, 2. Name of exporting organization, 3. Name or title of the recipient, 4. Radionuclide name, quantity, activity and overall activity, and 5. Unique identifiers such as manufacturer and model number,
and serial number. When the significant risk sealed radioactive material of Column 1 as
listed in Table II of the Appendix reaches port of destination, the
applicant or its designate shall pick up the goods forthwith, and
shall not store them in the warehouse of the port without permission of the competent authority.
Article 7 For the transfer of radioactive material or equipment capable of
producing ionizing radiation, the assignee shall fill out an
application form and make application to the competent authority for review and approval, after which the permit will be issued. For the application of the transfer of radioactive material in the
preceding paragraph, documents relating to the transport details
shall also be enclosed. In cases where facility operators possess a certificate of
permission duly issued by the competent authority or registration
approved by the competent authority for the use of non-sealed
radioactive material, the enclosure of documents referred to in the
preceding paragraph may be waived when the assignee makes
application for the transfer of non-sealed radioactive material. Article 8 For the export of radioactive material or equipment capable of
producing ionizing radiation, the applicant shall fill out an
application form and make application to the competent authority for review and approval, after which the permit will be issued.
For the application of the export of radioactive material in the
preceding paragraph, documents relating to the transport details
shall also be enclosed. Article 9 Applicants for the export of significant risk sealed radioactive
material of Column 1 as listed in Table II of the Appendix 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. The import agreement documentation referred to in the previous
paragraph shall specify the following: 1. Name or title of the recipient, 2. Recipient’s residence, firm or principal place of business, 3. Radionuclide name, quantity, activity and overall activity, 4. Unique identifiers such as manufacturer, model number, and
serial number, and 5. Estimated starting and ending time of shipment. Article 10 Applicants for the export of significant risk sealed radioactive
material of Column 1 or Column 2 as listed in Table II of the
Appendix 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,
the competent authority and recipient of the importing country:
1. Estimated date of export, 2. Name or title of the applicant, 3. Name or title of the recipient, 4. Radionuclide name, quantity, activity and overall activity, and 5. Unique identifiers such as manufacturer, model number, and
serial number. Article 11 Applicants for a permit to import or export a surface contaminated
object shall possess one of the following qualifications: 1. Government agency (or organization). 2. University, college or academic research organization. 3. Company or other legal person. 4. Medical institution set up with the official approval of the
public health competent authority. 5. Other qualifications as approved by the competent authority. Applications for the import or export of surface contaminated
objects shall conform with the Regulations for the Safe Transport of
Radioactive Material. Article 12 For the import or export of surface contaminated objects the
following documents shall be enclosed and application made to the
competent authority for review and approval, after which the permit
will be issued: 1. Data on the package or packaging smear test and surface
dose rate. 2. Documents relating to the transport details. Article 13 For the transit or transshipment en route of radioactive material,
the shipper or carrier shall enclose the radiation protection plan
and make application to the competent authority for review and
approval, after which the permit will be issued. The permit is
effective for a period of five years. The shipper or carrier having obtained the permit shall enclose the
transport documents to the competent authority for filing and
reference prior to transit or transshipment en route of any batch of radioactive material. The transit or transshipment en route of radioactive material shall
conform with the Regulations for the Safe Transport of Radioactive
Material. In cases of the transport of radioactive material in excepted
packages, the stipulations in Paragraphs 1 and 2 do not apply. Article 14 Permits for import, transfer, or export are effective for a period
of six months.
Section III Applications for a Permit, a Certificate of Permission or a
Registration for Filing and Reference for Use, Installation,
Modification or Possession Article15 Applicants for a certificate of permission or registration for
filing and reference for the use of radioactive material or
equipment capable of producing ionizing radiation shall possess one
of the following qualifications:
1. Government agency (or organization). 2. Post-secondary high (or vocational) school or academic research
organization. 3. Company or other legal person 4. Medical institution, radiology center or medical laboratory
established with the official approval of the public health
competent authority. 5. Veterinarian medical institutions officially established in
accordance with the Law Governing Veterinarian. 6. Other qualifications as approved by the competent authority. In the case of an application for use referred to in the preceding
paragraph, applicants shall meet the following criteria: 1. Have qualified operating personnel. 2. Possess a workplace or storage area meeting radiation safety
regulations. 3. Other criteria as designated by the competent authority. Article 16 For the use of the following radioactive materials, 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 of the Appendix. 2. Radioactive material that forms a component of an instrument or
manufactured product and that has a 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 micro-sieverts (μSv) per hour. 3. Radioactive materials besides those mentioned in the preceding
two subparagraphs with an activity less than 100 times that of
the exemption level. 4. Other radioactive materials as designated by the competent
authority. For the use of radioactive materials other than those stipulated in
the preceding paragraph, application for a certificate of permission shall be made to the competent authority. Article 17 For the use of the following equipment capable of producing ionizing
radiation, the applicant shall apply registration to the competent
authority for filing and reference: 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 micro-sieverts (μSv) per hour. 3. Other equipment as designated by the competent authority. For the use of equipment capable of producing ionizing radiation
other than those stipulated in the preceding paragraph, application
for a certificate of permission shall be made to the competent
authority. Article 18 Applicants for the use of sealed radioactive material or equipment
capable of producing ionizing radiation for which a permit
application shall be made shall, when applying for import or
transfer, fill out an application form, attach the following
documents and make application to the competent authority for
review. In cases requiring installation, installation permits will
be issued after review and approval; in cases not requiring
installation, following the issuance by the competent authority of
an import or transfer permit, the documents referred to in Paragraph 2 shall be enclosed to the competent authority for review,
inspection and approval, after which the certificate of permission
for use will be issued: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2. Photocopy of relevant operating personnel credentials and
certificate of employment. 3. Workplace radiation safety assessment. In cases not requiring
installation, a shielding planning need not be enclosed. 4. Radiation protection plan and radiation safety operation
guidelines. 5. Photocopy of authorization certificate 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. 6. For the use of sealed radioactive materials of Category I and
Category II as listed in Table I of the Appendix, documents
regarding security measures shall be submitted. Only after applicants referred to in the preceding paragraph have
obtained an installation permit can installation begin in accordance with the officially approved workplace radiation safety assessment,
floor plans and 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 certificate of permission for use will be issued: 1. Radiation safety survey report (hereinafter referred to as
“survey report”). 2. For sealed radioactive material conforming with the
stipulations referred to in Article 54, Paragraph 1, the sealed
radioactive material smear test report shall be submitted
(hereinafter referred to as “smear test report”). 3. For sealed radioactive material, a photocopy of the original
certifying document of radioactive material shall be submitted. Article19 For unsealed radioactive material or re-packaged and labeled
radioactive material whose use requires a permit, the applicant
shall fill out an application form, enclose the following documents
and make application to the competent authority for review and
approval, after which the installation permit will be issued: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2. Photocopy of relevant operating personnel credentials and
certificate of employment. 3. Workplace radiation safety assessment. 4. 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. 6. In conformity with the stipulations in the Standards for
Establishment of Radiation Protection Management Organizations
and Radiation Protection Personnel, a photocopy of the
authorization certificate of radiation protection personnel
shall be submitted. After obtaining permit for installation, the preceding applicant may process installation in accordance with the approved workplace
radiation safety assessment. Within 30 days after completion of
installation, the test report shall be enclosed to the competent
authority for review, inspection and approval, after which a
certificate of permission for use will be issued. Article 20 The workplace radiation safety assessment referred to in Article 18, Paragraph 1, Subparagraph 3 and in Paragraph 1, Subparagraph 3 of
the preceding Article, shall consider the following items as
appropriate for assessment 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 radioactive material or equipment
capable of producing ionizing radiation in a mobile
configuration. 4. Personal dose assessment. Article 21 A certificate of permission 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 a renewed certificate of permission for use will be issued: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2. Original certificate of permission for use. 3. A survey report done within the last 30 days. 4. For sealed radioactive materials qualifying regulations set
forth in Paragraph 1 of Article 54, the latest smear test
report shall also be enclosed. Article 22 Facility operators who have obtained a certificate of permission for
the 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
permit will be issued: 1. Workplace radiation safety assessment in accordance with the
stipulations of Article 20. 2. Photocopy of the credentials of the operating personnel. 3. Original certificate of permission for use. In cases where the modification referred to in the preceding
paragraph involves a change in radiation safety, the radiation
protection plan or radiation safety operating guidelines shall be
enclosed. Only after a facility operator obtains the permit for
modification may the modification work proceed in accordance with
the approved workplace radiation safety assessment. Within 30 days
after the work is completed, the following documents shall be
enclosed to the competent authority for review, inspection and
approval, after which the certificate of permission for use will be
issued: 1. Survey report. 2. For sealed radioactive material in conformity with the
stipulations referred to in Article 54, Paragraph 1, a smear
test report shall be provided. Article 23 For the use of sealed radioactive material that use requires a
registration for filing and reference approved by the competent
authority, applicants shall, when applying for import or transfer,
fill out an application form, attach the following documents and
make application to the competent authority for review. If
installation is required, the installation permit will be issued
after review and approval; if installation is not required, after
the competent authority issues the import or transfer permit, the
documents in Paragraph 2 are to be enclosed to the competent
authority for review and approval, after which the registration will be approved: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations).; 2. Photocopy of relevant qualified operating personnel credentials
and certificate of employment. 3. Workplace floor plans and shielding planning. Shielding
planning may be waived if installation is not required or
Paragraph 2 of Article 16 is qualified. 4. Radiation protection plan. Only after the applicant referred to in the preceding paragraph has
obtained the permit for modification may the modification 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
and approval, after which the registration will be approved: 1. Photocopy of the original radioactive material certification. 2. Survey report. 3. For sealed radioactive material in conformity with the
stipulations referred to in Article 54, Paragraph 1, a smear
test report shall be submitted. For the use of equipment capable of producing ionizing radiation
that requires a registration for filing and reference approved by
the competent authority, applicants shall fill out an application
form, enclose the following documents and make application to the
competent authority for review prior to use of the equipment, after
which the registration will be approved: 1. Name and number of certification of establishment or
registration approved. 2. Name and number of relevant qualified operating personnel
credentials. 3. Survey report related information. 4. Radiation protection plan. Article 24 For unsealed radioactive material or re-packaged, labeled
radioactive material, whose use requires registration, the applicant shall fill out an application form, attach the following documents
and make application to the competent authority for review and
approval, after which the registration will be approved: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2. Photocopy of relevant qualified operating personnel credentials
and certificate of employment. 3. Workplace floor plans and shielding planning. 4. Radiation protection plan. 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, facility operators who have registration
approved by the competent authority for radioactive material or
equipment capable of producing ionizing radiation one month prior to
or after the day equivalent to approved registration date, shall
conduct a radiation safety survey and record the results for future
reference. Article 26 When radioactive material for which the registration has been
permitted is to be modified, 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 the modification permit will be issued: 1. Workplace floor plans and shielding planning. 2. Photocopy of relevant qualified operating personnel
credentials. Only after facility operators have obtained the modification permit
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 the registration
will be approved: 1. Survey report. 2. For sealed radioactive material in conformity with the
stipulations referred to in Article 54, Paragraph 1, a smear
test report shall be provided. Facility operators who have registration approved by the competent
authority for radioactive material or equipment capable of producing ionizing radiation shall fill out application form and following
documents and enclose to the competent authority for review and
approval, after which the registration will be approved: 1. Name and number of relevant qualified operating personnel
credentials. 2. Survey report related information and radiation exam data. If, after modification, the energy level of the equipment capable of
producing ionizing radiation or the overall activity of the
radioactive material reaches the level stipulated that the
certificate of permission shall be applied for, then matters shall
proceed in accordance with the stipulations referred to in Article
22. Article 27 If radioactive material or equipment capable of producing ionizing
radiation is moved to a new location or there is a change of
workplace and therefore an installation or modification is involved, the facility operator shall fill out an application form and
separately apply for a certificate of permission for use or
registration for filing and reference in accordance with the
installation or modification stipulations referred to in Article 18, Article 22 and Article 23. If facility operators who have obtained a certificate of permission
or 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 separately for a certificate of permission or registration for filing and reference for use in accordance with the stipulations
referred to in Article 19 and Article 24. Article 28 For the use of a high-level radiation facility, the applicant shall
fill out an application form and enclose the following documents to
the competent authority for review and approval, after which a
permit for installation will be issued: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2. Workplace radiation safety assessment. 3. Radiation protection plan and radiation safety operation
guidelines. 4. The structure of workplace shielding and machinery and an
earthquake enduring level certification. 5. Operational training and practical operational training plan. 6. Pre-operational test plan and schedule. 7. For sealed radioactive material, a photocopy of the original
radioactive material certification and documents relating to
security procedures shall be enclosed. 8. Procedure for dealing with accidents. The workplace radiation safety assessment referred to in the
preceding paragraph, Subparagraph 2, 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). 4. Other information as designated by the competent authority. Only after the applicant has obtained the permit for installation
may the work proceed in accordance with the approved radiation
safety assessment, floor plans, and shielding planning. Within 30
days of completion of the work, a survey report shall be enclosed to the competent authority for review, inspection and approval, after
which a pre-operational test permit will be issued. After the completion of the pre-operational test, the applicant
shall enclose, within 30 days, a radiation safety analysis report
that includes the following items, to the competent authority for
review, inspection and approval, after which the certificate of
permission for use will be issued: 1. Area monitoring results. 2. Personal dose monitoring results. 3. Record of the pre-operational test. 4. Other items as designated by the competent authority. Article 29 The certificate of permission for use of a high-level radiation
facility 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 a renewed certificate of permission for use will be issued: 1. Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2. Survey report done within the last 30 days. Article 30 For installation or modification of radioactive material or
equipment capable of producing ionizing radiation, work shall be
completed within the time frames, as specified below. If work is not completed within the specified time frame, 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 or equipment
capable of producing ionizing radiation to which the permit
shall be applied, other than that referred to in the preceding
Subparagraph, 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 for filing and
reference is to be applied shall be completed within one year
of the approved import or transfer date. Article 31 In the case of the sale of sealed radioactive material referred to
in Article 16, Paragraph 1, Subparagraph 2 and an application for
possession of said item, the applicant shall fill out an application form, enclose the following documents and make application to the
competent authority for review, inspection and approval, after which the possession permit will be issued: 1. Permit of sales service businesses. 2. Applying documentation on the brand, model, nuclides, activity
and quantity of the radioactive material in possession. 3. Radiation protection plan. 4. Radiation safety assessment on appropriate storage area. Those who are permitted by the competent authority to engage in
sales of equipment capable of producing ionizing radiation may
possess approved equipment capable of producing ionizing radiation. Article 32 For any of the following situations, the applicant shall apply for
the possession permit : 1. Inability to complete the installation or modification within
the time frame stipulated in Article 30. 2. Subsequent to approval by the competent authority for import or
transfer, inability to proceed with installation following
delivery of material or equipment. 3. Other situations as approved by the competent authority. The applicant shall, 30 days prior to the deadline stipulated in
Article 30 or within 30 days from the delivery of the radioactive
material or equipment capable of producing ionizing radiation,
enclose the following documents and make application to the
competent authority for review. After the equipment capable of
producing ionizing radiation is reviewed and approved, the
possession permit will be issued; after the radioactive material is
reviewed, inspected and approved, the possession permit will be
issued: 1. Reason for possession. 2. Radiation protection plan. 3. Storage area. For radioactive material, the floor plans and
shielding planning shall be submitted. 4. For sealed radioactive material in conformity with the
stipulations of Article 54, Paragraph 1, a smear test report
shall be submitted. The possession permit referred to in the preceding paragraph is
effective for a maximum of two years. Facility operator may, within 60 to 30 days prior to expiration of
the possession permit of radioactive material or equipment capable
of producing ionizing radiation, fill out an application form and
enclose all documents provided in Paragraph 2 to the competent
authority for extension, which is subject to a maximum of one time.
Article 33 For a certificate of permission for radioactive material or
equipment capable of producing ionizing radiation or designated
items in the registration approved by the competent authority, if
there is change of printed items or loss or damage of the
certificate of permission, the facility operator shall, within 30
days of the occurrence, fill out an application form and apply to
the competent authority for a change, replacement or renewal. The period of effectiveness for the certificate of permission is the same as that for the original certificate. Article 34 When a facility operator replaces the X-ray tube or the accelerator
tube of equipment capable of producing ionizing radiation, he shall
proceed according to the following stipulations. However, the
following stipulations are not applicable to the replacement of the
X-ray tube of static electricity removers: 1. For those who obtain a certificate of permission for use, a
testing report shall be enclosed to the competent authority for
filing and reference within 15 days after the replacement. 2. For registration approved by the competent authority, the
testing report shall be independently kept. If a facility operator removes and replaces radioactive material for which he possesses a certificate of permission or registration
approved, he shall fill out an application and enclose the following documents prior to effecting the replacement, and enclose to the
competent authority for review and within 15 days following the
replacement and shall enclose a smear test report and a photocopy of the original certifying documentation of the newly installed
radioactive material to the competent authority for filing and
reference: 1. Documents relating to the transport details, 2. Method of processing the original radioactive material after
replacement For replacement of radioactive materials provided in the preceding
paragraph and the container at the same time, the application shall
be filed in accordance with stipulations set forth in Article 18 and Article 23 before replacement. Section IV Application for a Permit for Temporary or Permanent Cease of
Use Article 35 In cases where the use of radioactive material or equipment capable
of producing ionizing radiation must be ceased, the facility
operator shall fill out an application form, enclose the following
documents and make application to the competent authority for
review. After the equipment capable of producing ionizing radiation
is reviewed and approved, the permit for cease of use will be
issued; after the radioactive material is reviewed, inspected and
approved, the permit for cease of use will be issued: 1.The original certificate of permission for those who already
have said certificate. 2.Description of storage area. For radioactive material, a floor
plan of the storage area and the shielding planning shall be
submitted. The permits referred to in the preceding paragraph are effective for a maximum period of two years. The facility operator may, within 60 to 30 days prior to expiration
of ceased use of radioactive material or equipment capable of
producing ionizing radiation, fill out an application form and
enclose all documents provided in Paragraph 1 Subparagraph 2 to the
competent authority for extension. Article 36 In cases where an application is made to resume use of radioactive
material or equipment capable of producing ionizing radiation that
has previously obtained approval for cease of use, the procedure
shall follow the stipulations in Article 18 or Article 23; however,
an application for a permit for installation may be waived in the
case of use that will occur in a location originally approved by the competent authority. 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 application for the
resumption of use, fill out an application form, attach qualified
operating personnel credentials, and make application to the
competent authority for review and approval, after which the
certificate of permission will be issued or registration will be
approved. Article 37 When a facility operator permanently ceases the use of radioactive
material and treats it as radioactive waste, he shall fill out an
application form, enclose the following documents and make
application to the competent authority for inspection and approval,
after which a permit will be issued: 1.Sealed radioactive material discard plan. 2.Photocopy of original certifying document of radioactive
material. 3.Documents relating to the transport details. Following 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 said material, a
radiation workplace monitoring certificate, receipt documentation
and the original certificate of permission for those who already
have said certificate shall be enclosed and sent to the competent
authority for filing and reference. Article 38 When a facility operator permanently ceases use of radioactive
material or equipment capable of producing ionizing radiation and
disposes of it by shipping overseas, he shall fill out an
application form, documents relating to the transport details shall
be submitted for exporting radioactive material and make application to the competent authority for review and approval, after which the
permit will be issued. After the preceding application is approved by the competent
authority, the facility operator shall, within 30 days after
exportation, enclose a photocopy of the export documentations, the
original certificate of permission for those who already have said
certificate, the radiation workplace monitoring certificate shall
also be attached for exporting radioactive material and submitted to the competent authority for filing and reference. Article 39 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 permit, he 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 for filing and
reference, he shall proceed in accordance with the stipulations
of Articles 7 and 23. If the assignee referred to in the preceding paragraph is applying
for possession, he 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 discards it, he shall
fill out an application form, enclose the original certificate of
permission for those who already have said certificate and make
application to the competent authority for review and approval,
after which he 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 will request
the competent authority to send an official to conduct an inspection. Article 41 When a facility operator permanently ceases the use of unsealed
radioactive material, he shall fill out an application form, enclose the following documents and make application to the competent
authority for review and approval, after which he shall complete the decontamination in accordance with the approved plan and will
request the competent authority to conduct an inspection: 1.The original certificate of permission for those who already
have said certificate. 2.Decontamination plan. The decontamination plan referred to in the preceding paragraph,
subparagraph 2, shall include the decontamination schedule,
decontamination method, method for the treatment of radioactive
waste, division of the decontamination work area, and measures for
personnel control.
Section V Application for Display or Leasing Permits Article 42 Applicants for the display of radioactive material or equipment
capable of producing ionizing radiation shall possess one of the
following qualifications: 1.Government agency (or organization). 2.University, college or academic research organization. 3.Company or other legal person. 4.Other qualifications as approved by the competent authority. The application referred to in the preceding paragraph shall meet
the following criteria: 1.Applicant must be a business representative recognized by the
competent authority to engage in sales and service of
radioactive material or equipment capable of producing ionizing
radiation. 2.The period of display shall not exceed two months. Article 43 For a static display of equipment capable of producing ionizing
radiation, the applicant shall enclose the following documents and
make application to the competent authority for review and approval, after which the permit will be issued: 1.Catalog and explanatory diagrams. 2.Display plan and schedule. Article 44 For the following radioactive material or equipment capable of
producing ionizing radiation, application may be made for dynamic
display: 1.Radioactive material provided in Paragraph 1, Subparagraph 1 of
Article 16 that forms a component of an instrument or
manufactured product. 2.Radioactive material provided in Paragraph 1, Subparagraph 2 of
Article 16. 3.Equipment capable of producing ionizing radiation provided in
Paragraph 1, Subparagraph 1 and 2 of Article 17. 4.Others as designated by the competent authority. For the display referred to in the preceding paragraph, the
applicant shall attach the following documents and make application
to the competent authority for review and approval, after which the
permit will be issued: 1.Catalog, explanatory diagrams and information regarding
radiation safety. 2.Radiation protection plan. 3.Photocopy of credentials of relevant qualified operating
personnel. 4.Display plan and schedule. Article 45 An applicant for a leasing permit for radioactive material or
equipment capable of producing ionizing radiation shall possess one
of the following qualifications: 1.Government agency (or organization). 2.University, college or academic research organization. 3.Company or other legal person. 4.A medical institution, radiology center or medical laboratory
established with the approval of the public health competent
authority. 5.A veterinary hospital established in accordant with the Law
Governing Veterinarian. 6.Other qualification as approved by the competent authority. For the application for leasing referred to in the preceding
paragraph, the following criteria shall be met:
1.The lessee or borrower has qualified operating personnel or the
personnel is supplied by the lessor or lender. 2.The applicant possesses an appropriate workplace or storage
area. 3.Radioactive material or equipment capable of producing ionizing
radiation must be either mobile, carried-on-a-car or the
radioactive material is used for calibration purposes. Article 46 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 application to the competent authority for review and approval, after which the permit will be issued: 1.Photocopy of the original of the certificate of permission for
those who already have said certificate. 2.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, said assessment may be waived. 4.Radiation protection plan and radiation safety operation
guidelines. 5.Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 6.Photocopy of relevant qualified operating personnel credentials
and certificate of employment. When the lease period is over for the radioactive material or
equipment capable of producing ionizing radiation referred to in the preceding paragraph, the lessee or borrower shall immediately return the material or equipment to the lessor or lender and shall, within
one month, submit a survey report to the competent authority for
filing and reference. For sealed radioactive material conforming
with the stipulations of Article 54, Paragraph 1, a smear test
report shall be submitted.
Section VI Controls Article 47 The workplace and 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 the Appendix. Article 48 If practice of radioactive material or equipment capable of
producing ionizing radiation has one of following conditions, the
competent authority may cancel its permission, certificate of
permission, or registration: 1.The competent authority ordered to suspend all its practices
twice in one year; or ordered to suspend part of its practices
three times in one year. 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 the situation cannot
be improved, the material or equipment cannot be used, or the
situation cannot be improved within a specified time for over
one half 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 monitoring company authorized by the competent authority
or radiation protection personnel designated by the facility
operator. Article 50 If the facility operator uses unsealed radioactive material, he
shall, each week or after each use, conduct a monitoring of the
workplace contamination once and make a record.
At least twice a year, expelled wastewater samples shall be taken
and a survey analysis of the nuclides shall be conducted.
Article 51 With regard to the radioactive material or equipment capable of
producing ionizing radiation contained in the following documents,
the facility operator shall check and verify the inventory account
and status of use every six months, make a record of this and shall
keep said record for future reference: 1.A certificate of permission for use or possession permit of
radioactive material or registration approved by the competent
authority. 2.A certificate of permission for use or possession permit of
equipment capable of producing ionizing radiation. Article 52 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 said material.
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 surface of the packaging and the package and shall make a record of the surface
dose rate and a smear test. However, the above requirement does not
apply to radioactive material with activity or activity
concentration less than 100 times the exemption level, excepted
packages, or if the radioactive material is a noble gas. Article 54 If a facility operator uses or possesses a sealed radioactive
material with a half-life of more than 30 days, and that is beta or
gamma emitting nuclide with activity exceeding 3.7 MBq or is alpha
emitting nuclide with activity exceeding 370 kBq, he shall conduct a sealed radioactive material smear test within the time period
stipulated in Paragraph 3 and keep a record for future reference.
The following sealed radioactive materials are excepted from the
smear test referred to in the preceding paragraph: 1.Sealed radioactive material used for calibration that is
contained in a liquid scintillation counter. 2.Sealed gaseous radioactive material. 3.Other materials as designated by the competent authority. Smear test reports of sealed radioactive material shall be made by
the facility operator according to the times stipulated below: 1.Once every six months for sealed radioactive material in
teletherapy equipment and remote afterloading brachytheray
equipment. 2.Once a year for sealed radioactive material of other uses. 3.Once every three years for americium-241 contained in toxic gas
detectors. 4.Other actions announced by the competent authority shall be
completed according to the stipulated times. If the radioactive nuclide referred to in Paragraph 1 is radium, the smear test shall include a test for radon leakage.
If the smear test results referred to in Paragraph 1 exceed 185 Bq,
the facility operator shall cease use immediately and report to the
competent authority within seven days. Article 55 The stipulated radiation survey report, smear test report,
wastewater sample monitoring record, workplace monitoring record and periodic inventory account check record shall all be kept for five
years.
Section VII Supplementary Provisions Article 56 In applying for, or applying for renewal of, the various permits,
certificates of permission or registration for filing and reference
in conformity with the Regulations, the applicant shall enclose the
documents or filled-out information for review; besides those
stipulated in the Regulations, the competent authority may designate and announce others as needed.
Article 57 Licenses for radioactive material or equipment capable of producing
ionizing radiation granted by the competent authority prior to the
implementation of this Act may continue to be used until their
expiration dates. In the case of use after the expiration date, the
facility operator shall, 60 to 30 days prior to the deadline, fill
out an application form, attach the following documents and apply to the competent authority for a renewed certificate of permission or
registration for filing and reference. In the case of an application for a permit, following review, inspection and approval, the
certificate of permission for use will be issued; in the case of an
application for registration, following review and approval, the
registration will be approved: 1.Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2.Photocopy of relevant qualified operating personnel credentials
and certificate of employment. 3.Original license for equipment capable of producing ionizing
radiation or radioactive material. 4.Survey report done in the last 30 days. In the case of license application, prior to the implementation of
this Act, were exempted or excepted by public announcement and,
subsequent to the implementation of this Act, application is
required to be made for a permit or registration, the applicant
shall, within two years of the implementation of this Act, fill out
an application form, attach the following documents and make
application to the competent authority for review and approval,
after which the certificate of permission will be issued or
registration will be approved: 1.Photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations). 2.Photocopy of qualified operating personnel credentials and
certificate of employment. 3.Survey report. 4.Radiation protection plan. For a certificate of permission,
radiation safety operation guidelines shall also be enclosed. In cases where the renewal or application for radioactive material
referred to in the preceding two paragraphs as stipulated in Article 54, Paragraph 1, a smear test report shall be enclosed. Article 58 The format for all documents and forms stipulated in the Regulations
shall be determined by the competent authority. Article 59 The Regulations come into force upon promulgation. |