STATE OFFICE FOR RADIOLOGICAL AND NUCLEAR SAFETY 1538 Pursuant to Article 38, paragraph 2 of the Act on Radiological and Nuclear Safety (Official Gazette 28/10), the Director of the State Office for Radiological and Nuclear Safety, with the approval of the Minister of Health and Social Welfare, hereby issues the ORDINANCE ON THE AUTHORISATION OF EXPERT TECHNICAL SERVICES TO CARRY OUT PROFESSIONAL TASKS OF PROTECTION AGAINST IONISING RADIATION Article 1 This Ordinance stipulates the professional tasks involved in protection against ionising radiation, the requirements to be fulfilled by authorised expert technical services and the method of granting authorisation to expert technical services for carrying out professional tasks of protection against ionising radiation. Article 2 The professional tasks of protection against ionising radiation requiring authorisation include: 1. measurement of personal dose of external irradiation of exposed workers, apprentices or students undergoing training or education for working with ionising radiation sources; 2. measurement of personal dose of internal irradiation of exposed workers, apprentices or students undergoing training or education for working with ionising radiation sources; 3. testing x-ray sets, accelerators and any other apparatuses emitting ionising radiation, and providing opinions including risk assessments based on measurements and calculations; 4. testing sealed radioactive sources and apparatuses with sealed radioactive sources, and providing opinions including risk assessments based on measurements and calculations; 5. testing open radioactive sources and providing opinions including risk assessments based on measurements and calculations; 6. testing the premises where sources of ionising radiation are used and preparing documents which demonstrate whether the premises concerned comply with the prescribed requirements for protection against ionising radiation; 7. testing and monitoring types and activities of radioactive substances in the air, soil, sea, rivers, lakes, ground waters, precipitation, drinking water, foodstuffs and general use products; 8. testing the concentration of radon and radon progeny in the air. Article 3 Professional tasks of protection against ionising radiation may be carried out by expert technical services authorised by the State Office for Radiological and Nuclear Safety. Article 4 Authorisation for carrying out professional tasks of protection against ionising radiation shall be conditional on the expert technical service: 1. being registered with the Commercial Court for carrying out tasks of protection against ionising radiation; 2. having on staff at least two persons with a university degree and a minimum of five years of experience in performing ionising radiation protection tasks, of whom one with completed undergraduate and graduate university studies or integrated undergraduate and graduate university studies or specialist professional graduate studies in natural science (field of physics); 3. having made arrangements for measuring personal doses and for monitoring the health of workers handling sources of ionising radiation, and for their special professional training in the implementation of protection measures against ionising radiation, 4. having available working premises, owned or rented, which are adequate for the performance of the tasks for which authorisation is requested, 5. having available measuring instruments and other equipment necessary for performing the tasks for which authorisation is requested, calibrated in accordance with positive regulations, 6. having available a description of the procedures (methodology) involved in the performance of the tasks for which authorisation is requested, 7. holding valid accreditation in accordance with the requirements of the HRN EN ISO/IEC 17025 standard for the measurement method which is necessary, pursuant to Article 5, for the performance of those professional tasks of protection against ionising radiation for which authorisation is requested. Article 5 The measurement methods referred to in Article 4, item 7 of this Ordinance for which the expert technical service must obtain accreditation shall include: 1. measurement of personal doses of external irradiation of exposed workers by means of the personal dose equivalent Hp(10) for the professional tasks of protection against ionising radiation referred to in Article 2 item 1 of this Ordinance; 2. measurement of the ambient dose equivalent (H*(10) or the ambient dose equivalent rate (H*(10)/t) by means of portable radiation measuring instruments for the professional tasks of protection against ionising radiation referred to in Article 2, items 3, 4, 5 and 6 of this Ordinance; 3. implementation of high resolution gamma spectrometry of the appropriate energy resolution and of high resolution alpha and beta spectrometry for the detection of radionuclides for which authorisation is requested in the framework of the professional tasks of protection against ionising radiation referred to in Article 2, item 7 of this Ordinance. Article 6 (1) An expert technical service which complies with the requirements set out in Article 4 of this Ordinance shall submit its authorisation request for the pursuit of professional tasks of protection against ionising radiation to the State Office for Radiological and Nuclear Safety. (2) The request shall be accompanied with: 1. an excerpt from the Commercial Court register, 2. the list of employees who will perform professional tasks of protection against ionising radiation, including proof of their professional qualification and experience in protection against ionising radiation and of their employment, 3. proof that arrangements have been made for measuring personal doses and health monitoring of those workers who will work with ionising radiation sources and for their special professional training on the implementation of protection measures against ionising radiation, 4. proof of compliance with the requirements concerning working premises and technical equipment, 5. list of measuring instruments necessary for carrying out the activities for which authorisation is requested and calibration of those measuring instruments, 6. description of the procedures (methodology) involved in carrying out the tasks for which authorisation is requested, 7. copy of the accreditation certificate along with supporting documents in compliance with the requirements set out in the HRN EN ISO/IEC 17025 standard for the measurement methods necessary in carrying out the tasks for which authorisation is requested. Article 7 (1) The Director of the State Office for Radiological and Nuclear Safety shall appoint a Committee to issue opinions on compliance with the authorisation requirements for the pursuit of professional tasks in the protection against ionising radiation. (2) The Committee referred to in paragraph 1 of this Article shall be comprised of three members appointed by the Director of the State Office for Radiological and Nuclear Safety. (3) The Committee shall hold its meetings at the State Office premises. (4) The State Office for Radiological and Nuclear Safety shall forward, upon receipt, the requests referred to in Article 6, paragraph 1 of this Ordinance and the accompanying documents referred to in Article 6, paragraph 2 of this Ordinance to the Committee referred to in paragraph 1 of this Article. (5) After the opinion referred to in paragraph 1 of this Article has been issued, the State Office for Radiological and Nuclear Safety shall render a decision authorising expert technical services for the pursuit of certain professional tasks of protection against ionising radiation. Article 8 (1) The decision referred to in Article 7, paragraph 5 of this Ordinance shall be issued for a period corresponding to the period of validity of the accreditation certificate in accordance with the requirements of the HRN EN ISO/IEC 17025 standard, or for a maximum period of five years. (2) Three months prior to the expiration of the period referred to in paragraph 1 of this Article the authorised expert technical service may request the renewal of the authorisation procedure. Article 9 (1) The State Office for Radiological and Nuclear Safety shall withdraw the authorisation to perform certain professional tasks of protection against ionising radiation prior to the expiration of the period referred to in Article 8, paragraph 1 of this Ordinance from any authorised expert technical service where: - inspectional supervision establishes that the authorised expert technical service no longer complies with the prescribed requirements; – the authorised expert technical service fails to eradicate any identified flaws by the deadline specified in the decision on inspectional supervision – the accreditation authority which had issued the accreditation referred to in Article 4, item 7 of this Ordinance revokes the accreditation. (2) In the event of a temporary revocation of accreditation (suspension) by the authority that had issued the accreditation referred to in Article 4, item 7 of this Article, the authorised expert technical service must not carry out professional tasks of protection against ionising radiation for the length of the suspension in the field for which the accreditation is temporarily revoked (suspended). Article 10 The State Office for Radiological and Nuclear Safety shall publish the list of authorised expert technical services on its website. Article 11 (1) The State Office for Radiological and Nuclear Safety shall keep a register of authorised expert technical services. (2) Authorised expert technical services shall notify the State Office for Radiological and Nuclear Safety of any changes to the conditions under which the authorisation had been granted and shall provide evidence thereof. Article 12 This Ordinance shall enter into force on the eighth day after the day of its publication in the Official Gazette. Class: 011-01/11-02/3 Reg. No: 542-01-11-8 Zagreb, 17 June 2011 Director Dragan Kubelka, m. p.