GB 16361-2012 English PDFUS$979.00 · In stock
Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 16361-2012: Specification for patient radiological protection and quality control in nuclear medicine Status: Valid GB 16361: Historical versions
Basic dataStandard ID: GB 16361-2012 (GB16361-2012)Description (Translated English): Specification for patient radiological protection and quality control in nuclear medicine Sector / Industry: National Standard Classification of Chinese Standard: C57 Classification of International Standard: 13.280 Word Count Estimation: 44,429 Older Standard (superseded by this standard): GB 16361-1996 Quoted Standard: GB 18871-2002; GBZ 120; GBZ 179 Regulation (derived from): National Standards Bulletin No. 13 of 2012 Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This Chinese standard specifies the protection of patients in clinical nuclear medicine basic requirements, patient protection and safety, and quality control requirements. This standard applies to the radionuclide used in clinical nuclear medicine diagno GB 16361-2012: Specification for patient radiological protection and quality control in nuclear medicine---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Specification for patient radiological protection and quality control in nuclear medicine ICS 13.280 C57 National Standards of People's Republic of China Replacing GB 16361-1996 Protection and Quality Control of Nuclear Medicine clinical Specification Issued on. 2012-06-29 2012-10-01 implementation People's Republic of China Ministry of Health Standardization Administration of China released Table of ContentsIntroduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Basic requirements 2 5 patient protection and safety requirements 2 6 6 quality control requirements Appendix A (informative) clinical nuclear medicine diagnostic medical exposure guidance levels 9 Annex B (informative) had clinical nuclear medicine diagnosis and treatment of women breast-feeding break during the 11 recommendations Annex C (informative) had clinical nuclear medicine treatment of pregnant women to avoid periods of Recommendation 12 Estimation Appendix D (informative) receiving doses of 13 patients in clinical nuclear medicine Dose estimation method Appendix E (normative) near the nuclear medicine personnel of 34 patients Annex F (informative) of the Nuclear Medicine medical exposure control quality generic content 36 Annex G (informative) radionuclide activity meter performance measuring device and quality control inspection 37 Appendix H (informative) Quality control of nuclear medicine equipment inspection and verification 39ForewordThe standard Chapter 4, Chapter 5 are mandatory, the rest are recommended. This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces GB 16361-1996 "Clinical Nuclear Medicine Radiological protection standards for the patient." This standard compared with GB 16361-1996, the main technical changes are as follows. --- Original standard is mainly based on national standards GB 4792-1984 "Radiation Health Protection basic standards"; this standard is based primarily on It has been replaced by a new version of the basic standards 4792-1984 GB of GB 18871-2002 "ionizing radiation protection and safety of radiation sources fundamental Standard "and GB Z179-2006" medical exposure Radiological Protection basic requirements. " --- International standard original standard is mainly based on ICRP Publication 52 "ProtectionofthePatientinNuclear Medicine, Ann.ICRP17 (4), 1987 "; this standard is mainly based on the IAEA Safety Report No.40" ApplyingRa- diationSafetyStandardsinNuclearMedicine, 2005 ", as well as IAEA Safety Report No.63" Releaseof PatientsafterRadionuclideTherapy, 2009 "and the IAEA Technical Report No.454" QualityAssurancefor RadioactivityMeasurementinNuclearMedicine, 2006 ". --- Standard name from "clinical nuclear medicine patient radiation health protection standards" by "protection of patients in clinical nuclear medicine and quality control System Specifications. " --- Original standard Chapter 3 ~ Chapter 7 of the content integration, grouped into current standard Chapters 4 and 5, and there are more complementary and modify. --- Increased in Chapter 6 concerning quality control requirements. --- By the Appendix 2 to 8, and the corresponding references are given in the appendix. This standard is proposed and administered by the People's Republic of China Ministry of Health. This standard was drafted. Institute of Radiation Medicine, Chinese Academy of Medical Sciences, Sichuan Provincial Center for Disease Control and Prevention. The main drafters. Zhang Liangan, Zhang literary, Jiao Ling, Dingyan Qiu, He Ling, Yang Yi. This standard replaces the standards previously issued as follows. --- GB 16361-1996. Protection and Quality Control of Nuclear Medicine clinical Specification1 ScopeThis standard specifies the basic requirements for protection of clinical nuclear medicine patients, patient protection and safety, and quality control requirements. This standard applies to the radionuclides used for diagnosis and treatment of clinical nuclear medicine, but does not include the case of a particle source implantation.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 18871-2002 ionizing radiation protection and safety of radiation sources basic standards GB Z120 Nuclear Medicine Radiological protection standards GB Z179 basic requirements for medical exposure Radiological Protection3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Radiopharmaceuticals radiopharmaceutical For the purpose of diagnosis and treatment may be applied to the human body any compound containing radionuclides. In addition to the radioactive properties, chemical and biological On consideration, radioactive drugs and other drugs. 3.2 Radionuclide purity radionuclidicpurity Specific radioactivity short-lived radionuclides and daughters accounted for radioactivity total activity score. 3.3 Radiochemical purity radiochemicalpurity Radionuclides in the desired chemical form of the mass fraction. Note. If you can not reach the radiochemical purity requirements may lead to target specific radiopharmaceutical tissue deterioration, resulting in radiation on non-target organs. 3.4 Chemical purity chemicalpurity Regardless of the presence of radioactive or not, according to the desired chemical form of the mass fraction. In general, radiopharmaceuticals, there are only of Learn toxicity or physiological process radiopharmaceutical impurities proposed chemical purity requirements. 3.5 Radioactivity specificradioactivity Radiopharmaceutical unit mass contained radionuclide activity and activity concentration of bound and free form. 3.6 Radionuclide generators radionuclidegenerator The device can be isolated from the decay of its long half-life radionuclide-containing preparations (known as the parent) of the short half-life nuclides (called daughters) generated by the vulgar Called "cow."4 Basic requirementsRequirements 4.1 clinical nuclear medicine diagnosis and treatment units 4.1.1 clinical nuclear medicine diagnosis and treatment unit (hereinafter referred to as nuclear medicine units) should follow the "radiation medical management regulations" for clinical Practicing nuclear medicine diagnosis and treatment conditions (hereinafter referred to as clinics) provided personnel and equipment, and other related requirements, and GB 18871- 2002 GB Z179 and other related technical standards. 4.1.2 should be equipped to adapt its services and the performance of qualified nuclear medicine diagnostic equipment (including related auxiliary equipment), and protection of patients Quality control testing equipment, personal protective equipment. 4.1.3 in accordance with relevant regulations, regularly test equipment for verification or calibration, to obtain competent and effective verification or calibration certificate. When it is detected Instrument after major repairs, you should re-test or calibration. 4.1.4 should be set to adapt its services and meet the protection requirements of GB Z120 laboratory examination room, injection rooms, treatment ward And waiting areas and other workplaces and their corresponding protection facilities. 4.1.5 It should be noted configured to adapt its services and reasonable structure of various professionals, including enforcement of the Nuclear Medicine have qualified Industry, physicians and clinical nuclear medicine technician, etc., and they are active in patient protection and safety and quality control knowledge, training and assessment. 4.1.6 There shall be established radiological protection and quality assurance management organizations, various medical technicians in their work should strictly follow the protection and safety to Demand and quality control requirements, and undertake corresponding responsibilities. 4.1.7 should develop the Nuclear Medicine Clinic quality assurance program, including strengthening the establishment of a sound management system, including the protection of patients, from the management system Ensure the correct implementation of the Nuclear Medicine Clinic of the degree and quality control procedures. 4.1.8 should be possible for the implementation of treatment failures or mistakes, development of contingency plans, and training and emergency drills will likely The consequences of failure or error is minimized. 4.2 Requirements for clinical nuclear medicine practitioners and associated personnel 4.2.1 only with a qualified medical practitioner to the patient prescribing radiation therapy and should be administered to the patient by virtue of prescription treatment Therapeutic radiopharmaceuticals. 4.2.2 The practitioner should be the legitimacy to judge case by case, only to meet the requirements of the legitimacy of radiopharmaceuticals to issue medical prescriptions. 4.2.3 practitioners and related personnel should be strictly controlled indications, should clinical nuclear medicine diagnosis and treatment when administered to a patient sensitive radiopharmaceuticals strict control. 4.2.4 Before the implementation of the Nuclear Medicine Clinic, practitioners and stakeholders have a responsibility to possible risks to patients orally or in writing inform Or their families.5 patient protection and safety requirements5.1 Justification judgment 5.1.1 In determining the nuclear medicine clinic should first make a legitimacy judgment, to ensure that the expected benefits of treatment according to clinical need will exceed the Treatment may bring potential danger. 5.1.2 All new clinical nuclear medicine techniques and methods of treatment, should be made through the use of pre-judging the legitimacy; it has been judged proper technical and square Law, when made new or important evidence and the need to re-judgment, they should re legitimacy judgment. 5.1.3 clinical nuclear medicine physicians should have the corresponding characteristics of medical diagnostic imaging technology and its indications, its use should be strictly controlled indications range. Even if new clinical nuclear medicine techniques and methods has been done to judge the legitimacy, in for new indications shall also be carried out prior to the legitimacy judgment. 5.1.4 diagnostic radiopharmaceuticals, reference should guide the level of medical exposure, using expected to reach the minimum discharge required diagnostic purposes Radionuclide administered amount. And note view past patient examination data, in order to avoid unnecessary duplication of tests. 5.1.5 lactating and pregnant women administered diagnostic radiopharmaceuticals, should pay special attention to the legitimacy of judgment. Because the special needs of pregnant women pregnant When women perform imaging, we should assess the absorbed dose to the fetus suffered. 5.1.6 unless it is life-saving situations, pregnant women should not receive treatment radiopharmaceuticals, particularly those containing 131I and 32P of radiopharmaceuticals. Therapeutic radiopharmaceuticals, should normally be at the end of pregnancy and lactation were. When life-saving drugs and radioactive therapy, if the fetus Accept the dose does not exceed 100mGy, may not terminate the pregnancy. 5.1.7 In order to avoid fetal and embryonic accidental radiation exposure, whether pregnant patients respond to an inquiry, inspection and evaluation. And will have Off advisory note posted in clinical nuclear medicine departments of the place, especially the entrance and waiting area. 5.1.8 only if there is significant clinical indications only can children in radionuclide imaging examination, and should be based on the child's weight, body The surface area or other applicable guidelines to minimize the amount of radioactive drug administration should be as short as possible to select the half-life of the radionuclide. 5.1.9 In addition to the above provisions, it should also meet other requirements in GB Z179 legitimacy judgment. 5.2 Radiological Protection Optimization 5.2.1 General requirements 5.2.1.1 practitioner when issued radiopharmaceutical prescription should be. a) In the diagnosis can achieve the desired objective case, the patients received a dose as low as possible; b) To make full use of existing information, to avoid all unnecessary duplication of irradiation; c) there should be an actual medical exposure of nuclear medicine and radiopharmaceutical treatment prescription consistent verification procedures; d) in the implementation of nuclear medicine diagnostic tests, should refer to the appropriate medical exposure guidance levels (see Appendix A). 5.2.1.2 practitioners, technicians and other imaging staff can be reached in an acceptable image quality, the patient should take By dose as low as possible. Therefore, we should adopt the following measures. a) Depending on the choice of appropriate characteristics of patients administered radiopharmaceutical and its activity are available, particularly for children and organ Patients with functional impairment; b) non-blocking inspection organs using a radioactive drug absorption, and speed up the process; c) Note that the use of appropriate image acquisition and processing technology; d) practicing physicians, technicians and other imaging staff, in addition should have the appropriate professional skills, but also accept nuclear medicine diagnosis and treatment Quality control and technical training requirements and protection of knowledge. 5.2.1.3 unless there was a clear clinical indications for pregnant women receive treatment when administered radiopharmaceuticals should control. Women Administration of radiopharmaceuticals should be avoided during pregnancy. 5.2.2 diagnostic nuclear medicine in clinical optimization requirements 5.2.2.1 should technical specifications and related standards establish operating conditions, nuclear medicine equipment, in order to obtain the best image when, Patients receiving the smallest dose. 5.2.2.2 Nuclear Medicine staff to deal with the patient has been administered radiopharmaceuticals provide written and oral guidance, so that they are also after discharge Can effectively limit their exposure suffered by nurses and the public to reduce their family members, if not adults and pregnant women, in particular, his or her spouse Close. 5.2.2.3 for each patient should be done. a) prior to administration of diagnostic radiology drugs due process to determine the identity of the patient, the patient information before spraying the preparation and administration procedures; b) for each diagnostic procedure, should give due consideration to the guidance of medical exposure levels associated with the program; c) should be correct, detailed information related to the patient's record; d) should select the appropriate data acquisition conditions, in order to achieve the necessary diagnostic targets, patients receiving the lowest dose. example For example, to obtain the best image quality, should be selected collimator, energy window, matrix scale, acquisition time, the collimator opening angle, etc., And single photon emission computed tomography (SPECT) or positron emission tomography (PET) of the relevant parameters And zoom (zoom) factor; E) When using dynamic analysis, to obtain the best image quality, it should be appropriate to the number of frames, and other parameters chosen time interval; f) should be particularly careful to ensure that the collimator surface or other parts will not be caused by pollution affect image quality; g) after the implementation of the diagnosis, especially in a short time after the inspection, should encourage patients (especially children) more water, excretion, in order to accelerate Renal excretion of radiopharmaceuticals; h) drugs like diuretics or gallbladder generally do not interfere with inspection procedures, but it can affect radiopharmaceutical storage or sink in a specific organ product. This approach is sometimes used to increase the specificity of the examination, but also have a positive impact on radiation protection. 5.2.2.4 acceptance of radionuclide diagnosis of lactating women, should be implemented in Appendix B recommendation interrupt breastfeeding. 5.2.2.5 pregnant women, according to the following manner medical exposure optimization process. a) When using the radiopharmaceutical technetium -99m and nuclear medical diagnosis, can be directly applied to a smaller dosage and prolonged imaging time To optimize. Because of this radionuclide wear but the placental barrier, and thus will not cause fetal subjected to high doses of radiation, usually do not need at this time To estimate the fetal radiation dose. However, if the use of other radionuclides (such as iodine or gallium), should fetal dose calculation and risk Assessment; b) Pregnant women should be encouraged to drink plenty of water and urinating more, in order to quickly clear the radiopharmaceutical through maternal kidneys. Easy to cross the placental barrier Ingested fetus radiopharmaceuticals such as radioactive iodine, to prevent accidental exposure of the fetus caused. 5.2.3 clinical nuclear medicine treatment optimization requirements 5.2.3.1 shall have the following optimization measures. a) prior to administration of radiation therapy, due process to determine the identity of the patient, the patient's preparation before spraying and spraying programs and other relevant information; b) prior to administration of radiopharmaceuticals to women, to determine whether a patient is pregnant or breast-feeding; c) oral or written instructions to patients, their family members in order to reduce the irradiation and the public caused; d) pay special attention to prevent radioactive contamination from the patient's vomit and excrement caused; e) to inpatients receiving therapeutic doses of radiopharmaceuticals after their discharge time should be consistent with GB 18871-2002 and GB Z179 Requirements. 5.2.3.2 Those who accept the radiopharmaceutical therapy of breast-feeding women, it is recommended to discontinue nursing Appendix B shall be a period of time. 5.2.3.3 unless it is to save lives, pregnant women should not be implemented radiopharmaceutical therapy. We have received radiation therapy for women Appendix C gives a recommendation should avoid pregnancy for some time. 5.2.3.4 If the radionuclide dose administered to men, and in the chemical state of the ion and has a longer life, it is possible to make semen There are a lot of these radionuclides, affect the quality of sperm. Iodine-131 has accepted the recommendation (iodine), phosphorus-32 (phosphate) or radioactive strontium (chloro Strontium) men treated within four months not to have sexual intercourse. 5.2.4 clinical nuclear medicine use radioactive sources for calibration requirements 5.2.4.1 sealed radioactive sources used in clinical nuclear medicine, nuclear medicine unit should be made through the calibration laboratory dating back to the standard dose. 5.2.4.2 unsealed radioactive sources used in clinical nuclear medicine, nuclear medicine units should use the meter to measure the activity of living, and living by the meter Make per......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 16361-2012_English be delivered?Answer: Upon your order, we will start to translate GB 16361-2012_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 7 working days. 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