Radiation legal requirements

Another excellent method of quantitative analysis makes use of tagging with radioactive or stable isotopes [29,30]. Detection is by radiation, mass spectroscopy [31], or nuclear magnetic resonance [32], Unfortunately, experiments involving radioactivity require elaborate precautions and special laboratory rooms to avoid contamination and meet legal requirements, and mass-spectroscopic and NMR equipment is expensive and may not be available. 

Generally, sterility is synonym with the absence of any viable microorganisms including their spores. Currently, the available sterilization methods include heat sterilization (steam and hot-air sterilization), cold sterilization (gas sterilization, sterilization by ionizing radiation), sterilization by aqueous solution (aldehydes, peracetic acid, hypochlorite, hydrogen peroxide), and sterilization by filtration methods. The choice of method is based on recommendations in medicinal literature, legal requirements, and the compatibility of a medical product with the method used. The decision for a particular method has to take the following factors into consideration [954] ... 

The establishment of performance criteria for a given tumor marker test is not a simple process because accuracy and precision are unique for each type of analyte and its application. Establishing methodological limits for accuracy, precision, sensitivity, and specificity often requires standard reference materials, quality control materials, comparative studies, and actual clinical specimens. Accuracy and precision must be measured over the analyte reportable range for which the device is intended to be used. Sensitivity and specificity must be considered with respect to the intended clinical use of the device. Also, the indications for use should be carefully considered in the design of the study protocol. The indications for class II should be to monitor residual tumor after surgery (or radiation), the recurrence of tumor, or response to therapy. A 510(k) must provide clear evidence that the device is accurate, safe, effective, and substantially equivalent to a device legally marketed in the United States. 

Proper control of food irradiation applications should fulfill the requirements for both food technologies and radiation technologies. Application of well-established methods for measurement of absorbed radiation dose and the dose distribution helps to provide assurance that the radiation treatment is both effective and legally correct [133]. Computer tomography (CT) can provide detailed, high-resolution, and accurate dose maps for any arbitrary product and package configurations [134]. Such dose maps are an essential part of process validation. 

KOCHER, D.C. (1990). Classification and disposal of radioactive wastes— History and legal and regulatory requirements, Radiat. Prot. Manage. 7, 58-78. 

The IAEA Safety Requirements publication on Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety [ 1 ] sets out the requirements for a regulatory infrastructure. These include requirements in respect of the establishment of an independent regulatory body for nuclear facilities and the responsibilities and functions to be assigned to it. 

Nuclear medicine facihties also represent a special hazard. Normally, nuclear injections use a short-hved isotope Tc with a halfhfe of a little over 6 hours. If the injection is in a large animal, such as a horse, the personnel exposure level can be substantial and workers should be provided with personal radiation monitors. Collection of the feces and urine may be required. In addition, the animal may not be released to a member of the pubhc until the exposure levels fall below the legal limits for unmonitored persons (more on this later). X-rays of animals also represent a special hazard since one cannot simply teU an animal to hold still. Often taking of x-rays will require a person to hold the animal stiU. Holders wUl often receive substantial levels of scattered x-ray radiation so this duty should be spread among a number of individuals. 

Many laboratories conduct operations which do not require the use of radioactive materials, in the same space as those in which radioactive materials are employed. In many of these instances, different personnel are employed in the two programs. Nonusers of radioisotopes should be made sufficiently aware of the procedures required for the safe, legal use of radiation so that they will neither inadvertently violate any safety requirements for the use of byproduct radioactive materials, nor misunderstand any actions of the employees involved with radiation. While the licensed users of radioactive materials are present, they can and must take precautions to avoid exposing the other persons in the laboratory unnecessarily to radiation, but when they are not present, the nonusers need to be aware of the areas where radioactive sources and waste are stored and areas they should avoid if there is any possibility of contamination. If proper security procedures are followed, the latter should theoretically not be possible. Any area containing radioactive materials should be clearly marked with signs bearing the radiation symbol and the label ... 

Safety Objectives require that nuclear installations are designed and operated so as to keep all sources of radiation exposure under strict technical and administrative control. However, the Radiation Protection Objective does not preclude limited exposure of people or the release of legally authorized quantities of radioactive materials to the environment from installations in operational states. Such exposures and releases, however, must be stricdy controlled and must be in compliance with operational limits and radiation protection standards. 

For each position in the operating organization, a job description should be prepared that includes the minimum requirements, in terms of qualifications and experience, for that post. The minimum requirements for qualification will depend on the legal framework or the national practice of the State. The requirements may include the successful completion of specialized training courses and/or experience in operational radiation protection. 

In the U.S., the use of a dosimeter is required by the NRC if it is likely that a laboratory worker may become exposed during any calendar quarter to a dose greater than that listed in Table 13.8. However, users of low- to medium-energy beta emitters (e.g., tritium, C, S) need not wear a dosimeter as none will respond to the radiations of these materials. The dosimeter record must become a permanent and legal part of the radiation... 

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