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Section I
General Principles
Article 1
The Regulations are prescribed in accordance with the provisions
of Paragraph 29.5 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 refers to radioactive material
placed in a sealed container sufficient to provide isolation
from the outside under normal use.
2.Modification refers to 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 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.
3.Labeling refers to the process of combining a radioactive
nuclide with another material to form a radioactive compound.
4.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.
5.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 of greater than 30 MV
(2)equipment capable of producing ionizing radiation with a
particle energy rating of greater than 30 MeV; or
(3)the use of sealed radioactive material with an activity of
greater than 1,000 TBq.
6.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.
7.Transshipment en route 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.
8.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
There are five types of sealed radioactive material categorized
by their degree of potential detriment against human health and
environment as listed in Table I.
Section II
Application for a Permission of Import, Transfer, Export,
Transit or Transshipment En Route
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 possess one of the following
qualifications:
1.a government agency (or organization);
2.a post-secondary high (or vocational) school or academic
research organization;
3.a 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 veterinarian medical institution officially established in
accordance with the Law Governing Veterinarian; 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 Paragraph 4.1 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.a catalog and explanatory diagrams.
3.For radioactive material, documents relating to the transport
details shall also be enclosed.
Paragraph 5.2
The documents in Subparagraphs 5.1.1 and 5.1.2 shall be kept by
the applicants themselves and the submission of the documents to
the Competent Authority for review and approval may be waived
for equipment capable of producing ionizing radiation if the
registration of import for filing and reference is applied.
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 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 (7) days before the starting of
shipment operation at the port for the sealed radioactive
material referred to in Paragraph 6.1, 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 transfer of radioactive material or equipment capable of
producing ionizing radiation, assignees 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 7.2
For the applications of transfer of radioactive material
referred to in Paragraph 7.1, documents relating to the
transport details shall also be enclosed.
Paragraph 7.3
In cases where facility operators possess the permit duly
issued by the Competent Authority or the registration approved
by the Competent Authority for the use of unsealed radioactive
material, the enclosure of the documents referred to in
Paragraph 7.2 may be waived when the assignee makes an
application for 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 Paragraph 8.1, 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 Article 8, 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 Paragraph 9.1
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 (7) 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 (or organization);
2.a university, college or academic research organization;
3.a company or other legal person;
4.a medical institution set up with the official approval of the
public health competent 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 en route 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 (5) 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 en route
of any batch of radioactive material.
Paragraph 13.3
Transit or transshipment en route of radioactive material shall
conform 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 Paragraphs 13.1 and 13.2 do not
apply.
Article 14
The Permission of import, transfer, or export is effective for
a period of six (6) months.
Section III
Applications for a Permission, a Permit or a Registration for
Filing and Reference for Use, Installation, Modification or
Possession
Article15
Paragraph 15.1
Applicants who apply for a permit or a 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.a government agency (or organization);
2.a post-secondary high (or vocational) school or academic
research organization;
3.a company or other legal person;
4.a medical institution, radiology center or medical laboratory
established with the official approval of the public health
competent authority;
5.a veterinarian medical institution officially established in
accordance with the Law Governing Veterinarian; 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
Paragraph 15.1, 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 micro-sieverts (μSv) per hour;
3.radioactive material besides those mentioned in Subparagraphs
16.1.1 and 16.1.2 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
Paragraph 16.1, 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 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; 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 Paragraph 17.1 or for non-medical use of
those stipulated in Subparagraph 17.1.1 with direct irradiation on
human bodies, an application for a permit shall be made to the
Competent Authority.
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 (or
organizations);
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 and
Category II as listed in Table I, a security planning shall
be submitted.
Paragraph 18.2
Only after the applicants referred to in Paragraph 18.1 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
certifying document of radioactive material shall be submitted.
Article19
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 (or
organizations);
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 submitted.
Paragraph 19.2
Only after the applicants referred to in Paragraph 19.1 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 (5)
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 (or
organizations);
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 Paragraph 22.1
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 the 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, 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 pproval; 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.photocopy of the certification of establishment or the
registration approved; waived for government agencies (or
organizations);
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 Paragraph 23.1 have
obtained the modification permission may the modification
proceed in accordance with the approved workplace floor plans
and shielding planning. Within 30 days after completion of the
modification, 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 the use 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 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 number of the certification of establishment or the
registration approved;
2.name and 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.photocopy of the certification of establishment or the
registration approved; waived for government agencies (or
organizations);
2.photocopy 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 (5) years, the facility operators who have the
registration approved by the Competent Authority for
radioactive material or equipment capable of producing ionizing
radiation one (1) month prior to or after the day equivalent to
the approved registration date, shall conduct a radiation safety
survey and record the results for future reference.
Article 26
Paragraph 26.1
When the radioactive material for which the registration has
been permitted 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 permit will be issued:
1.workplace floor plans and shielding planning; and
2.photocopy of the relevant operating personnel credentials.
Paragraph 26.2
Only after the 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 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 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
certificate of permission 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, if there 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 certificate
of permission for use or a registration for filing and reference
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 certificate of
permission 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 certificate of permission
for use or a registration for filing and reference 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 permit for installation will be issued:
1.a photocopy of the certification of establishment or the
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 security planning shall
be enclosed; and
8.procedure for dealing with accidents.
Paragraph 28.2
The workplace radiation safety assessment referred to in
Subparagraph 28.1.2 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); and
4.other information as designated by the Competent Authority.
Paragraph 28.3
Only after the applicants have obtained the permit 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 survey report shall be enclosed to the Competent Authority for
review, inspection and approval, after which a pre-operational
test permit will be issued.
Paragraph 28.4
After the completion of the pre-operational test, the applicants
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 a
certificate of permission for use will be issued:
1.the area monitoring results;
2.the personal dose monitoring results;
3.the record of the pre-operational test; and
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 (5) 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 certificate of permission for
use will be issued:
1.a photocopy of the certification of establishment or the
registration approved; waived for government agencies (or
organizations); 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 (1) month prior to the deadline:
1.a high-level radiation facility shall be completed within two
(2) 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 Article 30.1,
shall be completed within one (1) 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 (1)
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 sealed 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
Subparagraph 16.1.2; or
2.those who are engaged in sales service businesses or radiation
protection detection businesses replace the sealed radioactive
material for facility operators and do temporary storage of
the material before export or transfer.
Paragraph 31.2
Applicants who apply for possession of sealed radioactive
material according to the stipulations in Subparagraphs 31.1.1
and 31.1.2 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 permit will be issued:
1.the permit of radiation protection service businesses;
2.application documentation on the brand, model, nuclide
,activity and quantity of the sealed radioactive material in
possession;
3.radiation protection plan; and
4.radiation safety assessment on an appropriate storage area and
shielding planning. They shall be finished 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 permit:
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 permit will be issued; after the
radioactive material is reviewed, inspected and approved, a
possession permit 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 permit referred to in Paragraph 32.2 is effective
for a maximum of two (2) years.
Paragraph 32.4
The facility operator may, within 60 to 30 days prior to the
expiration of the possession permit of the radioactive material
or the equipment capable of producing ionizing radiation, fill
out an application form and enclose all the documents provided
in Paragraph 32.2 to the Competent Authority for extension,
which is subject to a maximum of one (1) time.
Article 33
Paragraph 33.1
For the certificate of permission 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 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 change, reissue
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, he/she 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 independently kept.
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 15 days following
the replacement, he/she 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.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
Paragraph 34.2, 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 must 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 said
issued; 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 Paragraph 35.1 are effective for a
maximum period of two (2) 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 follow the stipulations in
Article 18 or Article 23; however, an application for a
permission for installation may be waived in the case of use
that will occur in the location originally approved by the
Competent Authority.
Paragraph 36.2
If the reason for the approved cease of use referred to in
Paragraph 36.1 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 treats it as radioactive waste, he/she
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 certifying 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
Paragraph 37.1 by the Competent Authority, the facility operator
shall, within three (3) 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 said issued 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, he/she 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 Paragraph 38.1 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 said issued, 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,
he/she 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/she shall proceed in accordance
with the stipulations of Articles 7 and 23.
Paragraph 39.2
If the assignee referred to in Paragraph 39.1 is applying for
possession, he/she 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, he/she shall fill out an application form,
enclose the original permit for use for those who have already
said issued 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 request the Competent Authority
to send an official to conduct an inspection.
Article 41
Paragraph 41.1
When a facility operator permanently ceases the use of unsealed
radioactive material, he/she 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 complete the decontamination in accordance with
the approved plan and request the Competent Authority to
conduct an inspection:
1.the original permit for use for those who have already said
issued; and
2.decontamination plan.
Paragraph 41.2
The decontamination plan referred to in Subparagraph 41.1.2
shall include decontamination schedule, decontamination
method, disposition method for radioactive waste, division of
the decontamination area and measures for personnel control.
Section V
Application for Display or Lease Permits
Article 42
Paragraph 42.1
Applicants who apply for a permission for display of
radioactive material or equipment capable of producing ionizing
radiation shall possess one of the following criteria:
1.applicants must 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 must 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 Paragraph 42.1 shall not
exceed two (2) 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.catalog 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 Paragraph 44.1, 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.catalog, explanatory diagrams and information regarding
radiation safety;
2.radiation protection plan;
3.a photocopy 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 (or organization);
2.university, college or academic research organization;
3.company or other legal person;
4.a medical institution, radiology center or medical laboratory;
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 Paragraph 45.1,
the following criteria shall be met:
1.the lessee or the borrower has qualified operating personnel
or the personnel are supplied 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 must be mobile, carried-in-a-cabinet,
carried-on-a-car or the radioactive material used for
calibration purposes.
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
said;
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.a photocopy of certification of establishment or registration
approved; waived for government agencies (or organizations);
and
6.photocopies of relevant qualified operating personnel
credentials and certificate of employment.
Paragraph 46.2
When the lease period is over for the radioactive material or
the equipment capable of producing ionizing radiation referred
to in Paragraph 46.1, the lessee or the borrower shall
immediately return the material or the equipment to the lessor
or the lender and shall, within one (1) 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 and Category II, its contents shall refer to the
matters stipulated in Appendix 2.
Paragraph 47-1.2
The security level and their functions of sealed radioactive
material of Category I and Category II shall be in accordance
with the stipulations set forth in Table 3.
Article 47-2
Prior to the implementation of the security planning for sealed
radioactive material of Category I and Category II, should
sealed radioactive material of Category I and Category II having
been set and the permitted associated practice be not in
accordance with the stipulations set forth in Article 47-1, they
shall be improved within one (1) year since the date of
promulgation of the amendment to the Regulations. However, this
period may be extended after permission by the Competent
Authority. The extension shall be limited to one (1) 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 cancel its permission, permit or
registration:
1.the Competent Authority ordered to suspend all its practices
twice in one (1) year; or ordered to suspend part of its
practices three times in one (1) 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 specified 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 measuring 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/she shall, each week or after each use, conduct a measuring
of the workplace contamination once and make a record. At least
twice a year, samples of the released wastewater shall be taken
and a nuclide analysis shall be conducted.
Article 51
With regard to the radioactive material or the equipment capable
of producing ionizing radiation specified in the following
documents, the facility operator shall check and verify the
inventory account and the status of use every six (6) months,
make a record of this and keep the record for filing and
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 Paragraph 52.1 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 or possesses a sealed radioactive
material with a half-life of more than 30 days that itself is a
beta or gamma emitting nuclide with an activity of exceeding 3.7
MBq or is an alpha emitting nuclide with an activity of
exceeding 370 kBq, he/she shall conduct a sealed radioactive
material smear test within the time period stipulated in
Paragraph 54.3 and keep a record for filing and reference.
Paragraph 54.2
The following sealed radioactive material may be excepted from
the smear test referred to in Paragraph 54.1:
1.sealed radioactive material that is contained in a liquid
scintillation counter and used for calibration;
2.sealed gaseous radioactive material; or
3.other materials as designated by the Competent Authority.
Paragraph 54.3
Smear test reports of sealed radioactive material shall be made
by the facility operator according to the times stipulated
below:
1.once every six (6) 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 (3) years for americium-241 contained in
toxic gas detectors; or
4.other actions announced by the Competent Authority shall be
completed according to the stipulated times.
Paragraph 54.4
If the radioactive nuclide referred to in Paragraph 54.1 is
radium,the smear test shall include a test for radon leakage.
Paragraph 54.5
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 (7) days.
Article 55
The stipulated radiation survey report, smear test report,
measuring records of liquid waste samples, measuring records of
workplace and periodic check records of inventory account shall
all be kept for five (5) years.
Section VII
Supplementary Provisions
Article 56
In making an application for or applying for renewal of the
various purposes of permission, permits or registration for
filing and reference in conformity with the Regulations, the
documents for review or the information to be filled out that
the applicant shall enclose may, besides those have been
stipulated in the 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
the Regulations shall be determined by the Competent Authority.
Article 59
The Regulations come into force upon the promulgation.
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