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Regulations Expert inspection Special knowledge regulations Medicine/dental medicine/technology Ascertaining the body dose Records

D Fig. 4.3. X-ray Ordinance and corresponding regulations and standards

According to the X-ray Ordinance, when operating X-ray diagnosis equipment it must be guaranteed that 4 the regulations of the Medical Product Law (MPG) are fulfilled for putting the equipment into circulation for the first time and commissioning the equipment, 4 all state-of-the-art equipment is present and measures taken as required to ensure that the protection regulations are heeded and 4 given the intended type of examination, it is guaranteed that the necessary image quality is achieved with the lowest possible radiation exposure.

The guarantee of the »necessary (physical) image quality« is a prime prerequisite in order to achieve the necessary »diagnostic image quality« in medical X-ray examinations (7 definitions in § 2 No.5 RoV). Diagnostic image quality for the various X-ray examinations is described in the »medical quality requirements« according to the »Guidelines for quality assurance in X-ray diagnosis« [7]. These guidelines must fundamentally also be applied when using surgical image intensifiers. The wide range of applications of these X-ray diagnosis machines is also indicated in the know-how recommendations for the application area »emergen-cy diagnosis« in the above mentioned special knowledge ordinance (7 Sect. 4.1.2.2). Given that when surgical image intensifiers are used it is also frequently necessary to perform treatment and progress checks, for example, and take documentation pictures, the corresponding »medical quality requirements« according to the stated guidelines can be considered and used in individual cases with clear differentiation to the requirements for » classical projection radiography (7 Sect. 4.1.1).

One essential aim of the amended X-ray Ordinance consists of minimising the radiation exposure of patients resulting from medical X-ray diagnosis as far as possible while complying with a defined image quality and use-related radiation exposure standards (»diagnostic reference values« - DRW). The measures mentioned above for radiation protection and quality assurance and the requirements made of the special qualifications of the doctors and their assistants apply to this specific end.

In addition, the amended X-ray Ordinance also implements the clearly reduced dose limit values for »persons with occupational exposure to radiation« and for the general public in national law (O Table 4.1).

The amended version of the X-ray Ordinance applies to X-ray radiation generated by accelerated electrons in the energy range between 5 kilo-electron-volt and 1 mega-electron-volt. All equipment for generating ionising radiation with higher energy, as used for example in radiotherapy, are subject to the provisions of the Radiation Protection Ordinance (StrlSchV). The basic aim of optimising radiation protection applies to both the Radiation Protection Ordinance and to the X-ray Ordinance and is also described by the so-called ALARA principle (»as low as reasonably achievable) in corresponding recommendations of the »International Commission on Radiological Protection« (ICRP), which comes into effect in interpreting radiation protection precautions.

4.1.2.2 Use of X-rays on people

According to the application principles of § 25 of the X-ray Ordinance, X-rays can be used »on people only in medical healing or dental healing, in medical research, in other cases intended or permitted by law or for examination according to the specifications of general occupational safety«.

Table 4.1. The new dose limit values [mSv]

Body dose

Limit values of the body dose for persons with occupational radiation exposure in

Cat. A Cat. B

individuals in the population

1. Effective dose

20/50

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