The Cabinet of Ministers of Ukraine

THE CABINET OF MINISTERS OF UKRAINE

DECREE

No.1382 of December 05, 2007

Kyiv

On Approving the Technical Regulations on Sealed Sources of Ionizing Radiation

In accordance with Article 14 of the Law of Ukraine “On Standards, Technical Regulations, and Conformity Assessment Procedures”, the Cabinet of Ministers of Ukraine hereby resolves:

1. To approve the Technical Regulations on Sealed Sources of Ionizing Radiation and the Action Plan to Implement the Technical Regulations on Sealed Sources of Ionizing Radiation, as attached.

2. To determine that the Technical Regulations on Sealed Sources of Ionizing Radiation shall be subject to application on a voluntary basis by subjects of activities in the field of nuclear power utilization until 2011 inclusive, and beginning from 2012, subject to mandatory application.

Prime Minister of Ukraine / V. YANUKOVYCH

Index 33

APPROVED
by Decree of the Cabinet of Ministers of Ukraine No. 1382of December 05, 2007

Technical RegulationS

on Sealed Sources of Ionizing Radiation

General Provisions

1. These Technical Regulations establish essential requirements for sealed sources of ionizing radiation with respect to ensuring radiation protection of personnel and the population, and of natural environment, against the impact of ionizing radiation, as well as the procedure for assessing conformity of such sources to the established requirements, and the procedure for application thereof.

2. For the purpose ofthis Technical Regulations, the terms shall have the following meanings:

Sealed source of ionizing radiation (hereinafter “sealed source”): radioactive substance completely packed in a solid protective casing made from non-radioactive material and/or encapsulated in a protective casing that is sufficiently strong to prevent leaking of the substance, under proper conditions of operation, during the established service life, as well as under off-design conditions;

Conformity assessment procedure module (hereinafter “the module”): a set of agreed-upon procedures for the assessment of an article’s conformity with the established requirements.

Other terms shall be used in the meanings as set out in the Laws of Ukraine “On Using Nuclear Energy and Radiation Safety”, "On Standardization”, “On Conformity Assessment”, “On Standards, Technical Regulations and Conformity Assessment Procedures”, and “On Accrediting Conformity Assessment Bodies”.

3. The validity of the Technical Regulations shall extend to all sealed sources of domestic or foreign manufacture that are exempted, in a procedureestablished by law, from regulating control.

4. Sealed sources shall be entered into circulation in the territory of Ukraine conditional on the affirmation of their conformity with the requirements of this Technical Regulations and on the recognition according to the established procedure, of the results of conformity assessment carried out beyond the borders of Ukraine.

Owner of a sealed source that is being entered into circulation in the territory of Ukraine according to the established procedure, shall be required beforehand to obtain a license for conducting activities involving the use of it.

Where a manufacturer or a supplier of a sealed source affixes on it the national conformity mark in virtue of other technical regulations, a record shall be made in the relevant technical documents of the conformity of such source to said regulations.

Essential Technical Requirements for Sealed Sources

5. Sealed sources must:

Be of such a design as under proper conditions of operation, will assure radiation safety in places of operation and storage, and possess a number stamped on the source and on its container. Where a reusable container is used, it must bear information on the source type;

Be manufactured in conformance with standards and technical specifications for the particular type of sealed source, and with other process documents approved according to the established procedure;

Be hermetically sealed (the level of hermiticity shall be determined by the application of one or another of the radiometric or non-radiometric methods, according to the established procedure);

Meet its purpose and satisfy the essential technical requirements.

Under proper conditions of operation, the essential technical requirements for sealed sources must be complied with during the established service life thereof.

Conformity Assessment Procedure

6. The assessment of a sealed source’s conformity with the requirements of this Technical Regulations (hereinafter “conformity assessment”) shall be carried out by the manufacturer or a person that is an Ukrainian resident, authorized by the manufacturer, by way of a declaration, or by a conformity assessment body appointed according to the established procedure by Derzhspozhyvstandart (The State Committee of Ukraine on Technical Regulation and Consumer Policy), by application of modules according to the Technical Regulation on Conformity Assessment Modules and to the requirements concerning the application of the national conformity mark, as applied in the Technical Regulations approved by the Cabinet of Ministers of Ukraine’s Decree No. 1585 of October 07, 2003 (“Ofitsiyniy Visnyk Ukrayiny”, 2003, No. 41, p. 2175; 2007, No. 1, p. 31), followed by the issuance of a certificate of conformity of the sealed source.

The form of the declaration of conformity is provided in Annex 1.

The choice of the conformity assessment procedure shall depend on the category of the sealed source concerned (Annex 2), and shall be made in accordance with the Technical Regulation on Conformity Assessment Modules and the requirements concerning the application of the national conformity mark, as applied in the Technical Regulations, by the manufacturer or a person that is an Ukrainian resident, authorized by the manufacturer, with application of one or another of the modules, or a combination of such (Annex 3).

This Technical Regulations shall put no restrictions on a manufacturer as regards the application of more complex modules.

7. Technical documents submitted by a manufacturer or a person that is an Ukrainian resident, authorized by the manufacturer, to the conformity assessment body, must contain the requirements for the sealed source design and for the conditions of its operation, technical maintenance, and repair; measures for ensuring safe storage and use of the sealed source; personnel skills; as well as photographs of the sealed source, its container, transportation packing, instrument, and equipment.

The technical documents, drawn up in the State language, shall assure the possibility to perform conformity assessment.

8. The duty to draw up a declaration of conformity and to affix on a sealed source the national conformity mark, shall be assigned, in the event of:

Entering into circulation a sealed source of domestic manufacture, to the manufacturer;

Entering into circulation a sealed source of foreign manufacture, to the person that is an Ukrainian resident, authorized by the manufacturer that supplies the sealed source.

In the absence of a person that is an Ukrainian resident, authorized by the manufacturer, the duty to draw up a declaration of conformity and to affix the national conformity mark, shall be assigned to the person that enters the sealed source of foreign manufacture into circulation.

9. Upon drawing up a declaration of conformity, the manufacturer or the person that is an Ukrainian resident, authorized by the manufacturer, shall affix the national conformity mark on the sealed source or on its container, transportation packing, instrument, or equipment and/or technical documents, in accordance with the Rules for Application of the National Conformity Mark approved by the Cabinet of Ministers of Ukraine’s Decree No. 1599 of November 29, 2001 (“Ofitsiyniy Visnyk Ukrayiny”, 2001, No. 49, p. 2188).

10. The presence of the National Conformity mark on a sealed source or its transportation packing, instrument, or equipment and/or technical documents, shall serve as evidence of the conformity of such source with the requirements of these Technical Regulations and with the norms of radiation safety.

11. A manufacturer or a person that is an Ukrainian resident, authorized by the manufacturer, shall be required for a period of ten years after entering into circulation a sealed source, to keep in file the declaration of its conformity and the technical documents listed in clause 7 of these Technical Regulations, and make them available for inspection according to the procedure established by law.

In the absence of a person authorized by the manufacturer, the duty to keep in file the declaration of conformity and the technical documents, shall be assigned to the person that entered such source into circulation.

Annex 1
to the Technical Regulations

DECLARATIONof Conformity of a Sealed Source of Ionizing Radiation withy the Requirements of the Technical Regulations

______
(full name of the manufacturer /authorized person that is an Ukrainian resident /
______
the person that enters into circulationa sealed source of ionizing radiation,
,
______
the person’s location, EDRPOU code (if available)
in the person of ______
(position, surname, first name and patronymic of the authorized person)
hereby confirms that ______
(full appellation of the sealed source of ionizing radiation)
manufactured according to ______
(titles and designation of the documents)
satisfies the requirements ofthe Technical Regulations on Sealed Sources of Ionizing Radiation according to ______
(title and designation of the normative documents
______
(if available) which serve as proof of the sealed source
______
of ionizing radiation’s conformity
______.
with the requirements of the Technical Regulations)
Conformity Certificate* ______
(the conformity certificate number, its date of registration,
______.
term of validity, name and location of the conformity assessment body)
This Declaration has been drawn up subject to full responsibility of the manufacturer / person that is an Ukrainian resident, authorized by the manufacturer /person that enters the sealed source of ionizing radiation into circulation
(strike out the inapplicable)
______
(position of the person that has drawn up the Declaration) / ______
(signature) / ______
(initials and surname)
(seal point) / ______
(date)
______
* Applies where the manufacturer makes use of the module under which the conformity assessment procedure for a sealed source of ionizing radiation is carried out by appointed bodies. / Place for mark
of registration of the Declaration
of Conformity
Annex 2
to the Technical Regulations

CATEGORIESof Sealed Sources of Ionizing Radiation

Table 1

Category of Sealed Source / Field of Application of Sealed Source 1 / Activity Ratio (A / D)2
1 / Radioisotope thermoelectric generators, irradiators, sources for teletherapy, and sources for multibeam teletherapy / A / D  1000
2 / Sources for industrial gamma radiography, sources for high and medium-activity brachytherapy / 1000 > A / D  10
3 / Stationary industrial measurement means containing high-activity sources, instruments for geophysical investigations and well logging / 10 > A / D  l
4 / Sources for low-activity brachytherapy, industrial measurement means not containing high-activity sources, bone densitometers, and static eliminators / l > A / D  0,01
5 / Sources for low-activity brachytherapy, instruments for X-ray fluorescence analysis, instruments for electron capture, sources for spectrometry, and test sources for positron emission tomography / 0,01 > A / D і А > level of dispensation from regulating control 3

______
1The list of sealed sources and their characteristics is provided in Table 2 of this Annex. If a sealed source is absent in Table 2, that source’s category shall be determined by the manufacturer / the person that is an Ukrainian resident, authorized by the manufacturer / the person that enters the sealed source into circulation, subject to coordination with Derzhatomreguliuvannia (the State Committee on Nuclear Regulation of Ukraine).

2The quantityD characterizes the activity of a sealed source that in the absence of regulating control, could lead to a significant irradiation sufficient to cause serious impact. The quantity А characterizes the activity as of the time of manufacture of the sealed source.

3The level of dispensation from regulating control shall be determined in accordance with the Procedure for State Registration of Ionizing Radiation Sources, approved by the Cabinet of Ministers of Ukraine’s Decree No. 1718 of November 16, 2000 (“Ofitsiyniy Visnyk Ukrayiny”, 2000, No. 47, p. 2034).

LIST
of Sealed Sources of Ionizing Radiation and of Characteristics Thereof

Table 2 of Annex 2

Appellation of Sealed Source / Radionuclide / Activity Value / Activity Quantity А, ТBq / Activity Quantity D, ТBq / Ratio of Activities, A/D
Category 1
Sources for radioisotope thermoelectric generators / Sr-90 / maximum / 3.3Е+02 / 1.0Е+00 / 2.5Е+04
minimum / 7.4Е+02 / 1.0Е+00 / 3.3Е+02
typical / 1.0Е+01 / 1.0Е+00 / 7.4Е+02
Pu-238 / maximum / 1.0Е+00 / 6.Е-02 / 1.7Е+02
minimum / 1.0Е+01 / 6.Е-02 / 1.7Е+01
typical / 5.6Е+05 / 6.Е-02 / 1.7Е+02
Irradiators used for sterilization / Co-60 / maximum / 1.9Е+02 / 3.Е-02 / 1.9Е+07
minimum / 1.5Е+05 / 3.Е-02 / 6.2Е+03
typical / 1.9Е+05 / 3.Е-02 / 4.9Е+06
Cs-137 / maximum / 1.9Е+02 / 1.Е-01 / 1.9Е+06
minimum / 1.1Е+05 / 1.Е-01 / 1.9Е+03
typical / 1.6Е+03 / 1.Е-01 / 1.1Е+06
Sources for autoprotective irradiators / Cs-137 / maximum / 9.3Е+01 / 1.Е-01 / 1.6Е+04
minimum / 5.6Е+02 / 1.Е-01 / 9.3Е+02
typical / 1.9Е+03 / 1.Е-01 / 5.6Е+03
Co-60 / maximum / 5.6Е+01 / 3.Е-02 / 6.2Е+04
minimum / 9.3Е+02 / 3.Е-02 / 1.9Е+03
typical / 4.4Е+02 / 3.Е-02 / 3.1Е+04
Sources for the irradiation of blood / tissue / Cs-137 / maximum / 3.7Е+01 / 1.Е-01 / 4.4Е+03
minimum / 2.6Е+02 / 1.Е-01 / 3.7Е+02
typical / 1.1Е+02 / 1.Е-01 / 2.6Е+03
Co-60 / maximum / 5.6Е+01 / 3.Е-02 / 3.7Е+03
minimum / 8.9Е+01 / 3.Е-02 / 1.9Е+03
typical / 3.7Е+02 / 3.Е-02 / 3.0Е+03
Sources for multibeam remote radiation therapy / Co-60 / maximum / 1.5Е+02 / 3.Е-02 / 1.2Е+04
minimum / 2.6Е+02 / 3.Е-02 / 4.9Е+03
typical / 5.6Е+02 / 3.Е-02 / 8.6Е+03
Sources for remote radiation therapy / Co-60 / maximum / 3.7Е+01 / 3.Е-02 / 1.9Е+04
minimum / 1.5Е+02 / 3.Е-02 / 1.2Е+03
typical / 5.6Е+01 / 3.Е-02 / 4.9Е+03
Cs-137 / maximum / 1.9Е+01 / 1.Е-01 / 5.6Е+02
minimum / 1.9Е+01 / 1.Е-01 / 1.9Е+02
typical / 3.3Е+02 / 1.Е-01 / 1.9Е+02
Category 2
Sources for industrial radiography / Co-60 / maximum / 7.4Е+00 / 3.Е-02 / 2.5Е+02
minimum / 4.1Е-01 / 3.Е-02 / 1.4Е+01
typical / 2.2Е+00 / 3.Е-02 / 7.4Е+01
Ir-192 / maximum / 7.4Е+00 / 8.Е-02 / 9.3Е+01
minimum / 1.9Е-01 / 8.Е-02 / 2.3Е+00
typical / 3.7Е+00 / 8.Е-02 / 4.6Е+01
Se-75 / maximum / 3.0Е+00 / 2.Е-01 / 1.5Е+01
minimum / 3.0Е+00 / 2.Е-01 / 1.5Е+01
typical / 3.0Е+00 / 2.Е-01 / 1.5Е+01
Yb-169 / maximum / 3.7Е-01 / 3.Е-01 / 1.2Е+00
minimum / 9.3Е-02 / 3.Е-01 / 3.1Е-01
typical / 1.9Е-01 / 3.Е-01 / 6.2Е-01
Tm-170 / maximum / 7.4Е+00 / 2.Е+01 / 3.7Е-01
minimum / 7.4Е-01 / 2.Е+01 / 3.7Е-02
typical / 5.6Е+00 / 2.Е+01 / 2.8Е-01
Sources for high / medium powerbrachytherapy / Co-60 / maximum / 7.4Е-01 / 3.Е-02 / 2.5Е+01
minimum / 1.9Е-01 / 3.Е-02 / 6.2Е+00
typical / 3.7Е-01 / 3.Е-02 / 1.2Е+01
Cs-137 / maximum / 3.0Е-01 / 1.Е-01 / 3.0Е+00
minimum / 1.1Е-01 / 1.Е-01 / 1.1Е+00
typical / 1.1Е-01 / 1.Е-01 / 1.1Е+00
Ir-192 / maximum / 4.4Е-01 / 8.Е-02 / 5.6Е+00
minimum / 1.1Е-01 / 8.Е-02 / 1.4Е+00
typical / 2.2Е-01 / 8.Е-02 / 2.8Е+00
Calibration sources / Co-60 / maximum / 1.2Е+00 / 3.Е-02 / 4.1Е+01
minimum / 2.0Е-02 / 3.Е-02 / 6.8Е-01
typical / 7.4Е-01 / 3.Е-02 / 2.5Е+01
Cs-137 / maximum / 1.1Е+02 / 1.Е-01 / 1.1Е+03
minimum / 5.6Е-02 / 1.Е-01 / 5.6Е-01
typical / 2.2Е+00 / 1.Е-01 / 2.2Е+01
Category 3
Sources for level sensors / Cs-137 / maximum / 1.9Е-01 / 1.Е-01 / 1.9Е+00
minimum / 3.7Е-02 / 1.Е-01 / 3.7Е-01
typical / 1.9Е-01 / 1.Е-01 / 1.9Е+00
Co-60 / maximum / 3.7Е-01 / 3.Е-02 / 1.2Е+01
minimum / 3.7Е-03 / 3.Е-02 / 1.2Е-01
typical / 1.9Е-01 / 3.Е-02 / 6.2Е+00
Calibration sources / Am-241 / maximum / 7.4Е-01 / 6.Е-02 / 1.2Е+01
minimum / 1.9Е-01 / 6.Е-02 / 3.1Е+00
typical / 3.7Е-01 / 6.Е-02 / 6.2Е+00
Sources for conveyor sensors / Cs-137 / maximum / 1.5Е+00 / 1.Е-01 / 1.5Е+01
minimum / 1.1Е-04 / 1.Е-01 / 1.1Е-03
typical / 1.1Е-01 / 1.Е-01 / 1.1Е+00
Cf-252 / maximum / 1.4Е-03 / 2.Е-02 / 6.8Е-02
minimum / 1.4Е-03 / 2.Е-02 / 6.8Е-02
typical / 1.4Е-03 / 2.Е-02 / 6.8Е-02
Sources for monitoring the burning-out of furnaces / Co-60 / maximum / 7.4Е-02 / 3.Е-02 / 2.5Е+00
minimum / 3.7Е-02 / 3.Е-02 / 1.2Е+00
typical / 3.7Е-02 / 3.Е-02 / 1.2Е+00
Sources for depth measurements / Co-60 / maximum / 9.6Е-02 / 3.Е-02 / 3.2Е+00
minimum / 9.3Е-03 / 3.Е-02 / 3.1Е-01
typical / 2.8Е-02 / 3.Е-02 / 9.3Е-01
Cs-137 / maximum / 3.7Е-01 / 1.Е-01 / 3.7Е+00
minimum / 7.4Е-03 / 1.Е-01 / 7.4Е-02
typical / 7.4Е-02 / 1.Е-01 / 7.4Е-01
Sources for rotary systems of pipe inspection / Cs-137 / maximum / 1.9Е-01 / 1.Е-01 / 1.9Е+00
minimum / 7.4Е-02 / 1.Е-01 / 7.4Е-01
typical / 7.4Е-02 / 1.Е-01 / 7.4Е-01
Sources for the start-up of experimental reactors / Am-241 / Be / maximum / 1.9Е-01 / 6.Е-02 / 3.1Е+00
minimum / 7.4Е-02 / 6.Е-02 / 1.2Е+00
typical / 7.4Е-02 / 6.Е-02 / 1.2Е+00
Sources for well logging devices / Am-241 / Be / maximum / 8.5Е-01 / 6.Е-02 / 1.4Е+01
minimum / 1.9Е-02 / 6.Е-02 / 3.1Е-01
typical / 7.4Е-01 / 6.Е-02 / 1.2Е+01
Cs-137 / maximum / 7.4Е-02 / 1.Е-01 / 7.4Е-01
minimum / 3.7Е-02 / 1.Е-01 / 3.7Е-01
typical / 7.4Е-02 / 1.Е-01 / 7.4Е-01
Cf-252 / maximum / 4.1Е-03 / 2.Е-02 / 2.0Е-01
minimum / 1.0Е-03 / 2.Е-02 / 5.0Е-02
typical / 1.1Е-03 / 2.Е-02 / 5.6Е-02
Sources for heart stimulators / Pu-238 / maximum / 3.0Е-01 / 6.Е-02 / 4.9Е+00
minimum / 1.1Е-01 / 6.Е-02 / 1.8Е+00
typical / 1.1Е-01 / 6.Е-02 / 1.9Е+00
Calibration sources / Pu-239 / Be / maximum / 3.7Е-01 / 6.Е-02 / 6.2Е+00
minimum / 7.4Е-02 / 6.Е-02 / 1.2Е+00
typical / 1.1Е-01 / 6.Е-02 / 1.9Е+00
Category 4
Sources for low-power brachytherapy / Cs-137 / maximum / 2.6Е-02 / 1.Е-01 / 2.6Е-01
minimum / 3.7Е-04 / 1.Е-01 / 3.7Е-03
typical / 1.9Е-02 / 1.Е-01 / 1.9Е-01
Ra-226 / maximum / 1.9Е-03 / 4.Е-02 / 4.6Е-02
minimum / 1.9Е-04 / 4.Е-02 / 4.6Е-03
typical / 5.6Е-04 / 4.Е-02 / 1.4Е-02
I-125 / maximum / 1.5Е-03 / 2.Е-01 / 7.4Е-03
minimum / 1.5Е-03 / 2.Е-01 / 7.4Е-03
typical / 1.5Е-03 / 2.Е-01 / 7.4Е-03
Ir-192 / maximum / 2.8Е-02 / 8.Е-02 / 3.5Е-01
minimum / 7.4Е-04 / 8.Е-02 / 9.3Е-03
typical / 1.9Е-02 / 8.Е-02 / 2.3Е-01
Au-198 / maximum / 3.0Е-03 / 2.Е-01 / 1.5Е-02
minimum / 3.0Е-03 / 2.Е-01 / 1.5Е-02
typical / 3.0Е-03 / 2.Е-01 / 1.5Е-02
Cf-252 / maximum / 3.1Е-03 / 2.Е-02 / 1.5Е-01
minimum / 3.1Е-03 / 2.Е-02 / 1.5Е-01
typical / 3.1Е-03 / 2.Е-02 / 1.5Е-01
Sources for thickness sensors / Kr-85 / maximum / 3.7Е-02 / 3.Е+01 / 1.2Е-03
minimum / 1.9Е-03 / 3.Е+01 / 6.2Е-05
typical / 3.7Е-02 / 3.Е+01 / 1.2Е-03
Sr-90 / maximum / 7.4Е-03 / 1.Е+00 / 7.4Е-03
minimum / 3.7Е-04 / 1.Е+00 / 3.7Е-04
typical / 3.7Е-03 / 1.Е+00 / 3.7Е-03
Am-241 / maximum / 2.2Е-02 / 6.Е-02 / 3.7Е-01
minimum / 1.1Е-02 / 6.Е-02 / 1.9Е-01
typical / 2.2Е-02 / 6.Е-02 / 3.7Е-01
Pm-147 / maximum / 1.9Е-03 / 4.Е+01 / 4.6Е-05
minimum / 7.4Е-05 / 4.Е+01 / 1.9Е-06
typical / 1.9Е-03 / 4.Е+01 / 4.6Е-05
Cm-244 / maximum / 3.7Е-02 / 5.Е-02 / 7.4Е-01
minimum / 7.4Е-03 / 5.Е-02 / 1.5Е-01
typical / 1.5Е-02 / 5.Е-02 / 3.0Е-01
Sources for level sensors / Am-241 / maximum / 4.4Е-03 / 6.Е-02 / 7.4Е-02
minimum / 4.4Е-04 / 6.Е-02 / 7.4Е-03
typical / 2.2Е-03 / 6.Е-02 / 3.7Е-02
Cs-137 / maximum / 2.4Е-03 / 1.Е-01 / 2.4Е-02
minimum / 1.9Е-03 / 1.Е-01 / 1.9Е-02
typical / 2.2Е-03 / 1.Е-01 / 2.2Е-02
Co-60 / maximum / 1.9Е-02 / 3.Е-02 / 6.2Е-01
minimum / 1.9Е-04 / 3.Е-02 / 6.2Е-03
typical / 8.7Е-04 / 3.Е-02 / 2.9Е-02
Calibration sources / Sr-90 / maximum / 7.4Е-02 / 1.Е+00 / 7.4Е-02
minimum / 7.4Е-02 / 1.Е+00 / 7.4Е-02
typical / 7.4Е-02 / 1.Е+00 / 7.4Е-02
Sources for humidity meters / Am-241 / Be / maximum / 3.7Е-03 / 6.Е-02 / 6.2Е-02
minimum / 1.9Е-03 / 6.Е-02 / 3.1Е-02
typical / 1.9Е-03 / 6.Е-02 / 3.1Е-02
Sources for density meters / Cs-137 / maximum / 3.7Е-04 / 1.Е-01 / 3.7Е-03
minimum / 3.0Е-04 / 1.Е-01 / 3.0Е-03
typical / 3.7Е-04 / 1.Е-01 / 3.7Е-03
Sources for humidity / density sensors / Am-241 / Be / maximum / 3.7Е-03 / 6.Е-02 / 6.2Е-02
minimum / 3.0Е-04 / 6.Е-02 / 4.9Е-03
typical / 1.9Е-03 / 6.Е-02 / 3.1Е-02
Cs-137 / maximum / 4.1Е-04 / 1.Е-01 / 4.1Е-03
minimum / 3.7Е-05 / 1.Е-01 / 3.0Е-04
typical / 3.7Е-04 / 1.Е-01 / 3.7Е-03
Ra-226 / maximum / 1.5Е-04 / 4.Е-02 / 3.7Е-03
minimum / 7.4Е-05 / 4.Е-02 / 1.9Е-03
typical / 7.4Е-05 / 4.Е-02 / 1.9Е-03
Cf-252 / maximum / 2.6Е-06 / 2.Е-02 / 1.3Е-04
minimum / 1.1Е-06 / 2.Е-02 / 5.6Е-05
typical / 2.2Е-06 / 2.Е-02 / 1.1Е-04
Sources for measuring bone density / Cd-109 / maximum / 7.4Е-04 / 2.Е+01 / 3.7Е-05
minimum / 7.4Е-04 / 2.Е+01 / 3.7Е-05
typical / 7.4Е-04 / 2.Е+01 / 3.7Е-05
Gd-153 / maximum / 5.6Е-02 / 1.Е+00 / 5.6Е-02
minimum / 7.4Е-04 / 1.Е+00 / 7.4Е-04
typical / 3.7Е-02 / 1.Е+00 / 3.7Е-02
I-125 / maximum / 3.0Е-02 / 2.Е-01 / 1.5Е-01
minimum / 1.5Е-03 / 2.Е-01 / 7.4Е-03
typical / 1.9Е-02 / 2.Е-01 / 9.3Е-02
Am-241 / maximum / 1.0Е-02 / 6.Е-02 / 1.7Е-01
minimum / 1.0Е-03 / 6.Е-02 / 1.7Е-02
typical / 5.0Е-03 / 6.Е-02 / 8.3Е-02
Sources for static elimination / Am-241 / maximum / 4.1Е-03 / 6.Е-02 / 6.8Е-02
minimum / 1.1Е-03 / 6.Е-02 / 1.9Е-02
typical / 1.1Е-03 / 6.Е-02 / 1.9Е-02
Po-210 / maximum / 4.1Е-03 / 6.Е-02 / 6.8Е-02
minimum / 1.1Е-03 / 6.Е-02 / 1.9Е-02
typical / 1.1Е-03 / 6.Е-02 / 1.9Е-02
Sources for diagnostics / Mo-99 / maximum / 3.7Е-01 / 3.Е-01 / 1.2Е+00
minimum / 3.7Е-02 / 3.Е-01 / 1.2Е-01
typical / 3.7Е-02 / 3.Е-01 / 1.2Е-01
Sources for medical purposes / I-131 / maximum / 7.4Е-03 / 2.Е-01 / 3.7Е-02
minimum / 3.7Е-03 / 2.Е-01 / 1.9Е-02
typical / 3.7Е-03 / 2.Е-01 / 1.9Е-02
Category 5
Sources for X-ray fluorescence analyzers / Fe-55 / maximum / 5.0Е-03 / 8.Е+02 / 6.2Е-06
minimum / 1.1Е-04 / 8.Е+02 / 1.4Е-07
typical / 7.4Е-04 / 8.Е+02 / 9.3Е-07
Cd-109 / maximum / 5.6Е-03 / 2.Е+01 / 2.8Е-04
minimum / 1.1Е-03 / 2.Е+01 / 5.6Е-05
typical / 1.1Е-03 / 2.Е+01 / 5.6Е-05
Co-57 / maximum / 1.5Е-03 / 7.Е-01 / 2.1Е-03
minimum / 5.6Е-04 / 7.Е-01 / 7.9Е-04
typical / 9.3Е-04 / 7.Е-01 / 1.3Е-03
Sources for electron capture detectors / Ni-63 / maximum / 7.4Е-04 / 6.Е+01 / 1.2Е-05
minimum / 1.9Е-04 / 6.Е+01 / 3.1Е-06
typical / 3.7Е-04 / 6.Е+01 / 6.2Е-06
H-3 / maximum / 1.1Е-02 / 2.Е+03 / 5.6Е-06
minimum / 1.9Е-03 / 2.Е+03 / 9.3Е-07
typical / 9.3Е-03 / 2.Е+03 / 4.6Е-06
Sources for the prevention of electric discharge / Am-241 / maximum / 4.8Е-04 / 6.Е-02 / 8.0Е-03
minimum / 4.8Е-05 / 6.Е-02 / 8.0Е-04
typical / 4.8Е-05 / 6.Е-02 / 8.0Е-04
Ra-226 / maximum / 3.0Е-06 / 4.Е-02 / 7.4Е-05
minimum / 2.6Е-07 / 4.Е-02 / 6.5Е-06
typical / 1.1Е-06 / 4.Е-02 / 2.8Е-05
H-3 / maximum / 7.4Е-03 / 2.Е+03 / 3.7Е-06
minimum / 7.4Е-03 / 2.Е+03 / 3.7Е-06
typical / 7.4Е-03 / 2.Е+03 / 3.7Е-06
Sources for brachytherapy (low-power applicators for eyes) / Sr-90 / maximum / 1.5Е-03 / 1.Е+00 / 1.5Е-03
minimum / 7.4Е-04 / 1.Е+00 / 7.4Е-04
typical / 9.3Е-04 / 1.Е+00 / 9.3Е-04
Ru / Rh-106 / maximum / 2.2Е-05 / 3.Е-01 / 7.4Е-05
minimum / 8.1Е-06 / 3.Е-01 / 2.7Е-05
typical / 2.2Е-05 / 3.Е-01 / 7.4Е-05
Pd-103 / maximum / 1.1Е-03 / 9.Е+01 / 1.2Е-05
minimum / 1.1Е-03 / 9.Е+01 / 1.2Е-05
typical / 1.1Е-03 / 9.Е+01 / 1.2Е-05
Sources for positron emission tomograph testing / Ge-68 / maximum / 3.7Е-04 / 7.Е-01 / 5.3Е-04
minimum / 3.7Е-05 / 7.Е-01 / 5.3Е-05
typical / 1.1Е-04 / 7.Е-01 / 1.6Е-04
Sources for spectrometry / Co-57 / maximum / 3.7Е-03 / 7.Е-01 / 5.3Е-03
minimum / 1.9Е-04 / 7.Е-01 / 2.6Е-04
typical / 1.9Е-03 / 7.Е-01 / 2.6Е-03
Tritium targets for neutron generators / H-3 / maximum / 1.1Е+00 / 2.Е+03 / 5.6Е-04
minimum / 1.1Е-01 / 2.Е+03 / 5.6Е-05
typical / 2.6Е-01 / 2.Е+03 / 1.3Е-04
Sources for medical purposes / P-32 / maximum / 2.2Е-02 / 1.Е+01 / 2.2Е-03
minimum / 2.2Е-03 / 1.Е+01 / 2.2Е-04
typical / 2.2Е-02 / 1.Е+01 / 2.2Е-03
Annex 3
to the Technical Regulations

LISTof Modules for Assessing Sealed Sources’ Conformity with the Requirements of the Technical Regulations

Sealed Source Category as per Annex 2 / Sealed SourceConformity Assessment Modules
1 / C+B or E+B, or F+B, or G, or H
2 / C+B or E+B, or F+B, or G
3 / C+B or D+B, or E+B, or F+B, or G
4 / Aa or B, or C+B, or D+B, or E+B, or F+B
5 / A or Aa, or B, or C+B, or D, or D+B,
or E, or E+B
APPROVED
by the Cabinet of Ministers of Ukraine’s Decree No. 1382of December 05, 2007

PLANof Measures Aimed at Implementing the Technical Regulations on Sealed Sources of Ionizing Radiation

Description of Measure / Persons Responsible for the Execution
1. Drawing up and publishing the List of national standards which in the event of voluntary application, shall be presumed proof of an ionizing radiation source’s conformity with the requirements of the Technical Regulations / Derzhspozhyvstandart
Derzhatomreguliuvannia
2. Promoting the application of the Technical Regulations provisions by way of engaging mass media means, and by holding seminars and conferences / - " -
3. Preparing domestic manufacturer enterprises for the manufacture of products that satisfy the requirements of the Technical Regulations / - " -
4. Tasks of the bodies assigned the responsibility for the assessment of sealed ionizing radiation sources’ conformity with the requirements of the Technical Regulations / - " -

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