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Title: Administrative Regulations for Radioactive Material and Equipment Capable of Producing Ionizing Radiation and Associated Practice Ch
Date: 2008.07.11
Legislative: 1.中華民國九十二年一月二十二日行政院原子能委員會會輻字第 0920001
511 號令訂定發布全文 57 條;本辦法自游離輻射防護法施行之日施行
2.中華民國九十四年二月二十三日行政院原子能委員會會輻字第 0940008
702 號令修正發布第 1、2、4~6、8、9、13、17、20、22、26~28、3
0、31、34、35、36、41、44、49、50、52、53、55、57 條條文;刪除
第 24 條條文;本辦法修正條文自發布日施行
3.中華民國九十四年十二月二十九日行政院原子能委員會會輻字第 09400
39736 號令增訂發布第 4-1、6-1、6-2 條條文
4.中華民國九十六年十月二十四日行政院原子能委員會會輻字第 0960028
431 號令修正發布全文 59 條;並自發布日施行
5.中華民國九十七年七月十一日行政院原子能委員會會輻字第 097001054
9 號令修正發布第 23、25、27、34、51、55 條條文
Content: Administrative Regulations for Radioactive Material and
Equipment Capable of Producing Ionizing Radiation
and Associated Practice

Promulgated on January 22, 2003 by the Atomic Energy Council Per its decree No.
Huei-Fu-Tsu-0920001511
Amendment of Article 1, Article 2, Article 4 to Article 6, Article 8, Article 9, Article 13,
Article 17, Article 20, Article 22, Article 24, Article 26 to Article 28, Article 30, Article 31,
Article 34 to Article 36, Article 41, Article 44, Article 49, Article 50, Article 52, Article 53,
Article 55, Article 57 and Appendix on February 23, 2005 by the Atomic Energy Council
per its decree No. Huei-Fu-Tsu-0940008702
Amendment of Article 4.1, Article 6.1, Article 6.2 and Table in the Appendix on
December 29, 2005 by the Atomic Energy Council per its decree No. Huei-Fu-Tsu-
0940039736
Amendment on October 24, 2007 by the Atomic Energy Council per its decree No.
Huei-Fu-Tsu-0960028431
Amendment of Article 23, Article 25, Article 27, Article 34, Article 51 and Article 55 on
July 11, 2008 by the Atomic Energy Council per its decree No. Huei-Fu-Tsu-0970010549
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
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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.
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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
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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 nonsealed
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
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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,
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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
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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 of radioactive material, the shipper or carrier shall enclose the transport
documents and make application to the competent authority for review and approval,
after which the permit will be issued:
For the transshipment en route the shipper or carrier shall enclose the following
documents and make application to the competent authority for review and approval,
after which the permit will be issued:
1. Transport documents.
2. Radiation protection plan.
3. Back transport plan.
The transit or transshipment en route of radioactive material shall conform with the
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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 the import, transfer, export, transit or transshipment en route 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.
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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
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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”).
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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
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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.
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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.
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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.
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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
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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.
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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 preoperational
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.
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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
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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.
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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.
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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.
22
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
23
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
24
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.
25
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.
26
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.
27
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
格式化: 字型: 12 點
28
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
29
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.
30
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
31
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.
32
Article 59
The Regulations come into force upon promulgation.
Appendix
Stipulations Governing Workplace and Shielding Planning for
Radioactive Material or Equipment Capable of Producing Ionizing
Radiation
I. Workplace floor plans and shielding planning for stationary use radioactive
material or equipment capable of producing ionizing radiation shall include:
(1) Description of the location of radioactive material or equipment capable of
producing ionizing radiation and perspective drawing.
(2) Description of workplace surroundings (including upstairs and downstairs).
(3) Material and thickness for shielding surrounding workplace.
(4) The direction of the primary radiation beam.
(5) Location of entrance and exit gates.
(6) Location of lead glass and its lead thickness equivalent; no requirement on
those who having not made such planning.
(7) Locations where safety interlocks are to be installed on entrance and exit
gates.
(8) Radiation warnings shall be pasted on entrance and exit gates and warning
lights shall be installed.
(9) Description of radiation dose during use or the process for calculating
shielding.
(10) Other relevant protection measures.
II. Workplace planning for mobile use radioactive material or equipment capable of
producing ionizing radiation shall include:
(1) Workplace of radioactive material or equipment capable of producing
ionizing radiation and description of surroundings.
33
(2) The direction of the primary radiation beam.
(3) Description of radiation dose or the process for calculating shielding.
(4) If mobile protective lead shielding is installed, the lead thickness equivalent
or other related protective measures shall be noted.
III. For radioactive material or equipment capable of producing ionizing radiation
used for medical therapy, a monitor and an emergency shut-off equipment shall be
installed in the therapy room.
IV. For a high-level radiation facility workplace, an alarm, a monitor, an emergency
shut-off equipment, and safety interlock shall be installed.
V. When radioactive material or equipment capable of producing ionizing radiation are
regularly used in the same location in a mobile configuration, they shall be
regarded the same as operating in a stationary configuration.
VI. When equipment capable of producing ionizing radiation is used for medical
purposes and there are two or more units installed in a therapy room or X-ray
room, each unit shall be equipped with a selector switch. Two or more apparatuses
of radioactive material may not share the same therapy room or X-ray room.
34
Table I Categories of Sealed Radioactive Material
Activity (A)
Nuclide
Category I
TBq
Category II
TBq
Category III
TBq
Category IV
TBq
Category V
TBq
Am-241 A≧6.E+01 6.E+01>A≧6.E-01 6.E-01>A≧6.E-02 6.E-02>A≧6.E-04 6.E-04>A>1.E-08
Am-241/Be A≧6.E+01 6.E+01>A≧6.E-01 6.E-01>A≧6.E-02 6.E-02>A≧6.E-04 6.E-04>A>1.E-08
Au-198 A≧2.E+02 2.E+02>A≧2.E+00 2.E+00>A≧2.E-01 2.E-01>A≧2.E-03 2.E-03>A>1.E-06
Cd-109 A≧2.E+04 2.E+04>A≧2.E+02 2.E+02>A≧2.E+01 2.E+01>A≧2.E-01 2.E-01>A>1.E-06
Cf-252 A≧2.E+01 2.E+01>A≧2.E-01 2.E-01>A≧2.E-02 2.E-02>A≧2.E-04 2.E-04>A>1.E-08
Cm-244 A≧5.E+01 5.E+01>A≧5.E-01 5.E-01>A≧5.E-02 5.E-02>A≧5.E-04 5.E-04>A>1.E-08
Co-57 A≧7.E+02 7.E+02>A≧7.E+00 7.E+00>A≧7.E-01 7.E-01>A≧7.E-03 7.E-03>A>1.E-06
Co-60 A≧3.E+01 3.E+01>A≧3.E-01 3.E-01>A≧3.E-02 3.E-02>A≧3.E-04 3.E-04>A>1.E-07
Cs-137 A≧1.E+02 1.E+02>A≧1.E+00 1.E+00>A≧1.E-01 1.E-01>A≧1.E-03 1.E-03>A>1.E-08
Fe-55 A≧8.E+05 8.E+05>A≧8.E+03 8.E+03>A≧8.E+02 8.E+02>A≧8.E+00 8.E+00>A>1.E-06
Gd-153 A≧1.E+03 1.E+03>A≧1.E+01 1.E+01>A≧1.E+00 1.E+00>A≧1.E-02 1.E-02>A>1.E-05
Ge-68 A≧7.E+01 7.E+01>A≧7.E-01 7.E-01>A≧7.E-02 7.E-02>A≧7.E-04 7.E-04>A>1.E-07
H-3 A≧2.E+06 2.E+06>A≧2.E+04 2.E+04>A≧2.E+03 2.E+03>A≧2.E+01 2.E+01>A>1.E-03
I-125 A≧2.E+02 2.E+02>A≧2.E+00 2.E+00>A≧2.E-01 2.E-01>A≧2.E-03 2.E-03>A>1.E-06
I-131 A≧2.E+02 2.E+02>A≧2.E+00 2.E+00>A≧2.E-01 2.E-01>A≧2.E-03 2.E-03>A>.E-06
Ir-192 A≧8.E+01 8.E+01>A≧8.E-01 8.E-01>A≧8.E-02 8.E-02>A≧8.E-04 8.E-04>A>1.E-08
Kr-85 A≧3.E+04 3.E+04>A≧3.E+02 3.E+02>A≧3.E+01 3.E+01>A≧3.E-01 3.E-01>A>1.E-08
Mo-99 A≧3.E+02 3.E+02>A≧3.E+00 3.E+00>A≧3.E-01 3.E-01>A≧3.E-03 3.E-03>A>1.E-06
Ni-63 A≧6.E+04 6.E+04>A≧6.E+02 6.E+02>A≧6.E+01 6.E+01>A≧6.E-01 6.E-01>A>1.E-04
P-32 A≧1.E+04 1.E+04>A≧1.E+02 1.E+02>A≧1.E+01 1.E+01>A≧1.E-01 1.E-01>A>1.E-07
Pd-103 A≧9.E+04 9.E+04>A≧9.E+02 9.E+02>A≧9.E+01 9.E+01>A≧9.E-01 9.E-01>A>1.E-04
Pm-147 A≧4.E+04 4.E+04>A≧4.E+02 4.E+02>A≧4.E+01 4.E+01>A≧4.E-01 4.E-01>A>1.E-05
Po-210 A≧6.E+01 6.E+01>A≧6.E-01 6.E-01>A≧6.E-02 6.E-02>A≧6.E-04 6.E-04>A>1.E-08
Pu-238 A≧6.E+01 6.E+01>A≧6.E-01 6.E-01>A≧6.E-02 6.E-02>A≧6.E-04 6.E-04>A>1.E-08
Pu-239/Be A≧6.E+01 6.E+01>A≧6.E-01 6.E-01>A≧6.E-02 6.E-02>A≧6.E-04 6.E-04>A>1.E-08
Ra-226 A≧4.E+01 4.E+01>A≧4.E-01 4.E-01>A≧4.E-02 4.E-02>A≧4.E-04 4.E-04>A>1.E-08
Ru-106 (Rh-106) A≧3.E+02 3.E+02>A≧3.E+00 3.E+00>A≧3.E-01 3.E-01>A≧3.E-03 3.E-03>A>1.E-07
Se-75 A≧2.E+02 2.E+02>A≧2.E+00 2.E+00>A≧2.E-01 2.E-01>A≧2.E-03 2.E-03>A>1.E-06
Sr-90 (Y-90) A≧1.E+03 1.E+03>A≧1.E+01 1.E+01>A≧1.E+00 1.E+00>A≧1.E-02 1.E-02>A>1.E-08
Tc-99M A≧7.E+02 7.E+02>A≧7.E+00 7.E+00>A≧7.E-01 7.E-01>A≧7.E-03 7.E-03>A>1.E-05
Tl-204 A≧2.E+04 2.E+04>A≧2.E+02 2.E+02>A≧2.E+01 2.E+01>A≧2.E-01 2.E-01>A>1.E-08
Tm-170 A≧2.E+04 2.E+04>A≧2.E+02 2.E+02>A≧2.E+01 2.E+01>A≧2.E-01 2.E-01>A>1.E-06
Yb-169 A≧3.E+02 3.E+02>A≧3.E+00 3.E+00>A≧3.E-01 3.E-01>A≧3.E-03 3.E-03>A>1.E-05
Note:
1. When more than two kinds of nuclides are included in each container, the
following formula shall be followed. If the result of the calculation is greater
than 1, then the previous category shall be followed.
35
Σ ⎟⎠

⎜⎝
⎛ + + +
n
n
n
AR
R
AR
R
AR
R
1 2
2
1
1
L
where,
R = activity of the nuclide for which import or export application is being made;
AR = upper limit of activity of the nuclide on the chart.
2. 1TBq equals to 1.E+12 Bq
36
Table II Import and Export Control on Significant Risk Sealed Radioactive Material
Dioactivity (A)
Nuclide
Column I Column II
TBq
TBq
Am-241 A≥6.E+01 6.E+01>A≥6.E-01
Am-241/Be A≥6.E+01 6.E+01>A≥6.E-01
Cf-252 A≥2.E+01 2.E+01>A≥2.E-01
Cm-244 A≥5.E+01 5.E+01>A≥5.E-01
Co-60 A≥3.E+01 3.E+01>A≥3.E-01
Cs-137 A≥1.E+02 1.E+02>A≥1.E+00
Gd-153 A≥1.E+03 1.E+03>A≥1.E+01
Ir-192 A≥8.E+01 8.E+01>A≥8.E-01
Pm-147 A≥4.E+04 4.E+04>A≥4.E+02
Pu- 238 A≥6.E+01 6.E+01>A≥6.E-01
Pu-239/Be A≥6.E+01 6.E+01>A≥6.E-01
Ra-226 A≥4.E+01 4.E+01>A≥4.E-01
Se-75 A≥2.E+02 2.E+02>A≥2.E+00
Sr-90 (Y-90) A≥1.E+03 1.E+03>A≥1.E+01
Tm-170 A≥2.E+04 2.E+04>A≥2.E+02
Yb-169 A≥3.E+02 3.E+02>A≥3.E+00
Note:
1. When the overall activity of any listed nuclide for import or export exceeds the
level shown on the chart, the stipulations of Article 6, 9 and 10 shall be followed.
2. When more than two listed nuclides are imported or exported, the following
formula should be used. If the result is greater than 1, then the stipulations of
Article 6, 9 and 10 shall be followed:
Σ ⎟⎠

⎜⎝
⎛ + + +
n
n
n
AR
R
AR
R
AR
R
1 2
2
1
1
L
where,
R = activity of the nuclide for which import or export application is being made;
AR = activity of the nuclide on the chart.
3. 1TBq equals to 1.E+12 Bq