Sanitary and epidemiological requirements for handling radioisotope devices and their construction

Registered in the Ministry of Justice of Russia on August 13, 2015 N 38518

FEDERAL SERVICE FOR SUPERVISION IN THE SPHERE OF DEFENSE

CONSUMER RIGHTS AND HUMAN WELL-BEING

CHIEF STATE SANITARY DOCTOR

OF THE RUSSIAN FEDERATION

RESOLUTION

from July 14, 2015 N 27

ON APPROVAL OF SANPIN 2.6.1.3287-15

"SANITARY AND EPIDEMIOLOGICAL REQUIREMENTS FOR HANDLING

WITH RADIOISOTOPE INSTRUMENTS AND THEIR DEVICE"

In accordance with the Federal Law of 30.03.1999 N 52-FZ "On the Sanitary and Epidemiological Welfare of the Population" (Collection of Legislation of the Russian Federation, 1999, N 14, Art. 1650; 2002, N 1 (Part I), Art. 2; 2003, N 2, Art. 167; N 27 (Part I), Art. 2700; 2004, N 35, Art. 3607; 2005, N 19, Art. 1752; 2006, N 1, Art. 10; N 52 (Part I), Art. 5498; 2007, N 1 (Part I), Art. 21; N 1 (Part I), Art. 29; N 27, Art. 3213; N 46, Art. 5554; N 49, Art. 6070; 2008, N 24, art. 2801; N 29 (part I), art. 3418; N 30 (part II), art. 3616; N 44, Art. 4984; N 52 (part I), art. 6223; 2009, N 1, art. 17; 2010, N 40, art. 4969; 2011, N 1, art. 6; N 30 (part I), art. 4563; N 30 (part I), art. 4590; N 30 (part I), art. 4591; N 30 (part I), art. 4596; N 50, art. 7359; 2012, N 24, Art. 3069; No. 26, Art. 3446; 2013, No. 27, Art. 3477; No. 30 (Part I), Art. 4079; No. 48, Art. 6165; 2014, No. 26 (Part I), Art. 3366, Art. 3377; 2015, No. 1 (Part I), Art. 11) and by the Decree of the Government of the Russian Federation of 24.07.2000 No. 554 "On Approval of the Regulation on the State Sanitary and Epidemiological Service of the Russian Federation and the Regulation on State Sanitary and Epidemiological Standardization" (Collection of Legislation of the Russian Federation, 2000, No. 31, Art. 3295; 2004, No. 8, Art. 663; No. 47, Art. 4666; 2005, N 39, art. 3953) I decree:

To approve sanitary rules SanPiN 2.6.1.3287-15 "Sanitary and epidemiological requirements for handling radioisotope devices and their design" (appendix).

A.Yu. POPOVA

Application

Approved

by decree of the Chief

state sanitary

Doctor of the Russian Federation

from 14.07.2015 N 27

SANITARY AND EPIDEMIOLOGICAL REQUIREMENTS

ON THE HANDLING OF RADIOISOTOPE INSTRUMENTS AND THEIR DESIGN

Sanitary rules

SanPiN 2.6.1.3287-15

I. Scope of application

1.1. These sanitary rules (hereinafter referred to as the Rules) establish requirements for ensuring radiation safety of the population and personnel in all types of handling radioisotope devices (hereinafter referred to as RID).

1.2. The rules apply to the design, construction, manufacture, sale, testing, installation, operation, maintenance (including adjustment and repair), recharging of sources, radiation monitoring, transportation, storage, dismantling and disposal of radioactive sources .

1.3. The rules are mandatory for all citizens, individual entrepreneurs and legal entities (hereinafter referred to as organizations).

1.4. The requirements of the rules do not apply to products containing tritium (light signs, neutron generator targets, spark gaps, etc.), gamma flaw detectors , and radioisotope power sources.

II. General Provisions

2.1. Radioisotope instruments include level gauges, thickness gauges, density gauges, item counters, pressure gauges, moisture meters, radioisotope smoke detectors, analyzers and other instruments based on the use of ionizing radiation from sealed radionuclide sources (hereinafter referred to as sources).

Factors that determine the radiation hazard of RIP depending on the radionuclide composition of the sources used in it and their activity may be:

- gamma radiation;

- bremsstrahlung;

- alpha radiation;

- beta radiation;

- neutron radiation;

- radioactive contamination of surfaces;

- various combinations of the above factors.

2.2. At all stages of handling RIP, conditions must be ensured that exclude the possibility of irradiation of the population and personnel in excess of the basic limits of man-made radiation doses established in paragraph 3.1.2 of SanPiN 2.6.1.2523-09 "Radiation Safety Standards (NRB-99/2009)" <1> (hereinafter referred to as NRB-99/2009).

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<1> Approved by the decree of the Chief State Sanitary Doctor of the Russian Federation dated 07.07.2009 N 47, registered by the Ministry of Justice of Russia on 14.08.2009, registration N 14534.

2.3. RIPs, according to the degree of radiation hazard depending on the type and activity of the sources used in their composition, are divided into 4 groups in accordance with the appendix to these Rules.

2.4. Persons not younger than 18 years of age, who do not have medical contraindications, who are classified as personnel of group A, who have undergone training in the rules for working with RIP and briefing on radiation safety, are allowed to handle (manufacture, sale, testing, installation, operation, maintenance (including adjustment and repair), recharging of sources, radiation monitoring, transportation, storage, dismantling and disposal) RIP of groups 2–4.

2.5. Handling of RIP of group 4 is permitted if there is a license for activities in the field of handling sealed radionuclide sources of ionizing radiation.

2.6. Handling of RIP of groups 2-4 is permitted after the execution of a sanitary and epidemiological conclusion on the compliance of working conditions with sources of ionizing radiation with sanitary rules (hereinafter referred to as SEZ).

2.7. RIPs of group 1 are exempt from control in accordance with paragraph 1.7.2 of SP 2.6.1.2612-10 "Basic sanitary rules for ensuring radiation safety (OSPORB-99/2010)" <1> (hereinafter - OSPORB-99/2010).

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<1> Approved by the Resolution of the Chief State Sanitary Doctor of the Russian Federation dated 26.04.2010 N 40, registered by the Ministry of Justice of Russia on 11.08.2010, registration N 18115, with amendments introduced by the Resolution of the Chief State Sanitary Doctor of the Russian Federation dated 16.09.2013 N 43, registered by the Ministry of Justice of Russia on 05.11.2013, registration N 30309.

2.8. RIPs of group 2 are exempt from control in accordance with paragraph 1.7.2 of OSPORB-99/2010 if the following conditions are met simultaneously:

- the ambient dose equivalent rate at any accessible point at a distance of 10 cm from the surface of the RIP under any possible operating and storage mode does not exceed 1 μSv/h;

- the radioactive contents of the source used in the RIP are sealed under all permissible operating and storage conditions;

- replacement of the source in the RIP by the user is not allowed, the source block is sealed and access to the source is impossible without breaking the manufacturer's seal.

2.9. Organizations handling RIP of groups 2–4 annually fill out the organization’s radiation-hygienic passport.

2.10. The provisions of paragraphs 2.4, 2.6 and 2.9 of these Rules do not apply to RIPs of group 2 exempt from control.

III. Requirements for the RIP device

3.1. RIPs that comply with the requirements of NRB-99/2009, OSPORB-99/2010 and these Rules are permitted for use.

In order to ensure the possibility of safe operation of the RIP, the technical documentation supplied to the consumer together with the RIP must contain a description of the design of the RIP, its technical characteristics, operating instructions, radiation safety and radiation control, information about the source used in the RIP, recommendations for placement or a standard project for the safe placement of the RIP.

3.2. The operating conditions and placement of the RIP (pressure, temperature, humidity, presence of aggressive environments, etc.) must comply with the technical documentation. The permissible operating conditions of the sources used in the RIP must comply with the operating conditions of the RIP.

3.3. The design of the RIP must provide for:

- the presence of devices that inform about the position of the source ("work" or "storage") in the source block;

- the ability to block the exit of the direct radiation beam beyond the source block and reduce radiation levels to acceptable levels when the source is in the "storage" position;

- fixation of the source in the "work" and "storage" positions, eliminating the possibility of transferring the source from the "storage" position to the "work" position without using a special "key" to release the lock, but allowing it to be transferred without hindrance from the "work" position to the "storage" position;

- the impossibility of accessing the source without using a special tool and without damaging the manufacturer's seal;

- fastening of stationary RIPs, eliminating the possibility of their unauthorized removal.

The requirements of paragraphs 2–4 of this clause do not apply to RIPs in which the radiation beam is not directed beyond the RIP housing and the source is stationary.

3.4. The design of the radiation protection of the RIP (source units) must be resistant to mechanical, chemical, temperature and other influences corresponding to the operating conditions of the RIP.

The RIP source unit must not have removable surface radioactive contamination exceeding 0.4 Bq/cm2 for beta-emitting radionuclides and 0.04 Bq/cm2 for alpha-emitting radionuclides.

3.5. For RIPs of group 1, as well as RIPs of group 2 exempt from control, the ambient dose equivalent rate of radiation at a distance of 0.1 m from any accessible point on the surface of the source unit under any possible operating conditions must not exceed 1.0 μSv/h.

3.6. The ambient dose equivalent rate of radiation at a distance of 1.0 m from the surface of the source block of RIP 2 - 4 groups must not exceed 20 µSv/h. For RIP 2 - 4 groups intended for use in production facilities with permanent workplaces, the ambient dose equivalent rate of radiation must not exceed 100 µSv/h at a distance of 10 cm and 3.0 µSv/h at a distance of 1.0 m from the surface of the source block.

The requirements of this paragraph shall be met for all accessible points when the source is in the "storage" position and for all accessible points outside the direct radiation beam zone when the source is in the "operating" position.

3.7. Work with portable RIPs of all groups, the ambient dose equivalent rate of radiation at a distance of 1.0 m from any accessible point on the surface of which, including in the zone of the direct radiation beam, under any possible operating conditions does not exceed 1.0 μSv/h, may be carried out in any production premises and outdoors. Work with portable RIPs that do not meet this requirement is permitted only in premises specified in the SEZ.

3.8. Radiation hazard signs, clearly visible from a distance of at least 3.0 m, must be applied to the outer surfaces of the RIP (source block). For RIP of group 1, as well as for RIP of group 2 exempt from control, it is permissible to apply a radiation hazard sign on the inner surface of the housing or on the source block.

IV. Requirements for handling RIP

4.1. Receipt and transfer of RIP groups 2–4 to another organization is carried out in the manner established by paragraphs 3.5.1–3.5.4 of OSPORB-99/2010.

4.2. The organization that received RIPs of groups 2–4 and the organization that delivered them shall notify the federal state sanitary and epidemiological supervision authorities of this in writing.

4.3. The conditions for obtaining, storing, using and writing off RIPs with sources from the register must exclude the possibility of their loss or uncontrolled use.

4.4. All received RIPs and the sources contained in them are subject to accounting. RIPs are accounted for by name and factory numbers, indicating the activity and number of each source included in the set.

4.5. Before receiving RIPs of groups 2–4, a list of persons admitted to work with them is approved, their necessary training is provided, persons responsible for ensuring radiation safety, accounting and storage of sources, organizing the collection, storage and disposal of radioactive waste, and radiation monitoring are appointed.

4.6. Temporary storage of source units of stationary RIPs of groups 2-4 shall be carried out in a special room that excludes access to them by unauthorized persons and ensures the safety of the sources. During temporary storage, the sources in the source units shall be in the "storage" position. The ambient dose equivalent rate at a distance of 0.1 m from the surface of the external walls, doors and windows of the room for temporary storage of stationary RIPs of groups 2-4 or on the external surface of its enclosure that excludes access by unauthorized persons shall not exceed 1.0 μSv/h.

4.7. Portable RIPs of groups 2–4 shall be stored in rooms that ensure their safety and exclude the possibility of their unauthorized use. The output of the working radiation beam shall be blocked. The ambient dose equivalent rate at a distance of 0.1 m from the surface of the external walls, doors, and windows of the room for storing portable RIPs or on the external surface of its enclosure, excluding access by unauthorized persons, shall not exceed 1.0 μSv/h.

4.8. Portable RIPs of groups 2–4 are issued from storage locations to employees authorized to work with them, by the person responsible for their storage and accounting, with the written permission of the head of the organization or a person authorized by him. The issue and return of each portable RIP is recorded in the log.

4.9. Transportation of RIPs of groups 2–4 with sources is carried out in accordance with the requirements of OSPORB-99/2010 and SanPiN 2.6.1.1281-03 “Sanitary rules for radiation safety of personnel and the population during transportation of radioactive materials (substances)” <1>.

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<1> Approved by the decree of the Chief State Sanitary Doctor of the Russian Federation dated 17.04.2003 N 54, registered by the Ministry of Justice of Russia on 13.05.2003, registration N 4529.

4.10. The placement and use of RIPs of groups 2–4 (including radioisotope smoke detectors) in children’s organizations and residential buildings and premises is not permitted.

4.11. Installation of stationary RIPs of groups 2 - 4 is carried out in accordance with technical documentation and a project that meets the requirements of NRB-99/2009, OSPORB-99/2010 and these Rules. The method of installation and fastening of RIPs must exclude the possibility of their unauthorized removal and ensure the safety of the sources.

4.12. When installing RIPs of group 4, they are removed as far as possible from permanent work places.

4.13. When installing and operating RIPs of groups 2–4, the following requirements must be met:

- direct the radiation beam in the direction that is safest for people working in the given and adjacent rooms (towards the ground, a load-bearing wall, etc.);

- install the RIP so that the ambient dose equivalent rate at the permanent workplaces of persons not classified as group A or B personnel does not exceed 0.5 μSv/h, and in places where people may be present does not exceed 1.0 μSv/h;

- place the blocks of stationary RIP sources of groups 2-4 at a distance of at least 1.0 m from permanent work places and from places where people may be located.

4.14. After installation of stationary RIPs of 2 - 4 groups, the ambient dose equivalent rate of radiation should be measured:

- at a distance of 0.1 m from the outer surface of the source block and at a distance of 1.0 m from it;

- at workplaces located within a radius of 10 m from the source unit;

- in places where persons not associated with the operation of the RIP and the equipment on which it is installed may be present, within a radius of 10 m from the source unit.

Additionally, the presence of removable radioactive contamination of the source block surface must be monitored.

4.15. If the placement of the RIP and the results of radiation monitoring comply with the requirements of these Rules, the RIP may be put into operation.

4.16. Removal of sources from RIP source units, unless provided for in the operating instructions, is not permitted.

4.17. Charging (recharging) of the source unit must be performed only by sources specified in the technical documentation for the RIP.

It is not permitted to use for this purpose sources that are not provided for in the technical documentation, differ from them in physical parameters (activity, radionuclide, size) or whose established service life has expired.

4.18. RIPs of all groups that are not subject to further use must be dismantled, and the sources contained in them must be handed over for disposal to specialized organizations or returned to the RIP manufacturer.

4.19. The requirements of paragraphs 4.1, 4.2, 4.5 - 4.9 of these Rules do not apply to RIPs of group 2, exempt from control.

V. Radiation control

5.1. Organizations using RIPs of groups 2–4 (except for RIPs of group 2, exempt from control) conduct radiation monitoring at workplaces, in the premises and on the territory of the organization, as well as monitoring and recording of individual radiation doses of personnel.

The frequency, volume and types of radiation monitoring depend on the type and quantity of RIPs used in the organization and are reflected in the industrial radiation monitoring program.

5.2. Radiation monitoring is carried out by the person responsible for radiation safety, the radiation safety service of the organization, or a radiation monitoring laboratory accredited in the relevant measurement areas.

5.3. Depending on the sources used in the RIP (radionuclide, type of radiation), radiation monitoring includes measurement of the following parameters:

- individual doses of external irradiation of group A personnel;

- ambient dose equivalent power of gamma radiation;

- ambient dose equivalent power of bremsstrahlung;

- ambient dose equivalent rate of neutron radiation;

- removable surface radioactive contamination of RIP and equipment with alpha- or beta-emitting radionuclides.

Measurements of the ambient dose equivalent rate at workplaces and in places where people may be located are carried out at four heights: 0.5, 1.0, 1.5 m and 2.0 m above the floor (the values of the ambient dose equivalent rate measured at all heights should not exceed 0.5 μSv/h at permanent workplaces of persons not classified as group A or B personnel, and 1.0 μSv/h in places where people may be located).

5.4. Organizations using RIP conduct:

- weekly visual inspection of stationary RIPs of 2-4 groups with checking the integrity of seals and locks of source units and recording the inspection results;

- weekly check of the availability of sources in the blocks of RIP sources of groups 2 - 4;

- quarterly check of the reliability of fastening of the blocks of stationary RIP sources of groups 2-4 and additional radiation protection structures (if provided);

- quarterly verification of compliance of the ambient dose equivalent rate at a distance of 0.1 m from the surface of portable RIPs of groups 2–4 and at a distance of 1.0 m from them with the requirements of these Rules, with the exception of RIPs of group 2 exempt from control;

- verification of compliance of the ambient dose equivalent rate at a distance of 1.0 m from the surface of the source units of stationary RIPs of groups 2–4, at workplaces and in places where people may be present, with the requirements of these Rules, with the exception of RIPs of group 2, exempt from control (once every six months);

- control over the presence of stationary RIPs of group 1 at the places of their installation (once every six months);

- annual inspection of the presence of removable surface radioactive contamination of the source block of RIP 2 - 4 groups, with the exception of RIP 2 groups, exempt from control.

When operating stationary RIPs (source units) under vibration (impact) conditions, the reliability of their fastening is checked daily.

5.5. Extraordinary radiation monitoring is carried out in the following cases:

- unauthorized entry of third parties into the premises for storing RIP;

- fire or other emergency in the premises for storage or operation of RIP;

- violation of the integrity of the seal or lock of the source block;

- after repair of the equipment on which the RIP is installed, if this RIP was dismantled;

- after installation, replacement or recharging of the source unit;

- after installing additional radiation protection;

- during and after the elimination of the consequences of a radiation accident.

5.6. For Group A personnel, individual dosimetric monitoring of external irradiation is organized with the results recorded at least once per quarter.

5.7. To carry out radiation monitoring, measuring instruments intended for measuring the controlled quantities and having a valid verification certificate must be used.

VI. Prevention of possible radiation accidents

and the elimination of their consequences

6.1. Radiation accidents during handling of RIP include:

- loss or theft of the source, source block or RIP;

- loss of source from the RIP source block;

- depressurization of a closed radionuclide source of RIP;

- radioactive contamination of people, clothing, and the environment as a result of depressurization of the RIP source;

- destruction or reduction of the protective properties of the radiation protection of the RIP source unit or additional radiation protection (if any);

- malfunction of the mechanism for transferring the source from the "operating" position to the "storage" position or the mechanism for blocking the working radiation beam;

- spontaneous movement (fall) of a stationary RIP as a result of destruction or weakening of the devices for its fastening;

- irradiation of personnel or the population as a result of improper operation of the RIP.

6.2. The administration of an organization carrying out activities using RIP develops and approves instructions on personnel actions in emergency situations and an action plan for personnel protection in the event of a radiation accident, which is agreed upon with the bodies implementing federal state sanitary and epidemiological supervision.

6.3. In the event of a radiation accident involving a RIP, the following measures should be taken immediately:

- stop work at the emergency site;

- remove people from the suspected radiation accident zone and mark the accident zone with radiation hazard signs;

- notify the administration, the radiation safety service or the person responsible for radiation safety.

6.4. In the event of a radiation accident, the administration of the organization must:

- take all necessary measures to restore control over the radiation source;

- immediately notify the higher organization and government authorities, including the bodies implementing federal state sanitary and epidemiological supervision, as well as local government bodies, about the radiation accident;

- organize radiation monitoring of the radiation accident zone, determine the boundaries of the radiation hazardous zone within which the ambient dose equivalent rate exceeds 1 μSv/h or there is radioactive contamination of equipment, premises or territory. People must be removed from this zone, fences and radiation hazard signs must be installed along its boundary, clearly visible from a distance of at least 3 m, and measures must be taken to prevent unauthorized persons from entering this zone;

- if radioactive contamination is detected in the accident zone, organize monitoring of radioactive contamination of clothing, footwear and skin of persons removed from the radiation accident zone and, if necessary, organize their decontamination;

- in case of loss of the source, take measures to find it using radiation monitoring equipment.

6.5. The personnel of the radiation facility and, if necessary, emergency rescue teams licensed for the relevant type of activity must be involved in the work to eliminate the accident and its consequences. All work to eliminate the consequences of the accident and the performance of other activities associated with possible overexposure of personnel are carried out under radiation control under a special permit (admission), which specifies the maximum duration of work, primary and additional means of protection, dosimetric monitoring means, in compliance with the requirements of Chapter VI of OSPORB-99/2010.

6.6. The elimination of the consequences of an accident and the investigation of its causes, if necessary, are carried out at the federal, regional and territorial levels in accordance with the procedure established by the legislation of the Russian Federation.

6.7. Resumption of work in the area of a liquidated accident is possible only with the consent of the bodies implementing federal state sanitary and epidemiological supervision.

Application

to SanPiN 2.6.1.3287-15

GROUPS

RIP DEPENDING ON THE TYPE AND ACTIVITY OF THE PRODUCTS USED

THEIR SOURCES CONTAIN