Remerciez-le!

Remerciez @Admin pour avoir partagé cet document gratuitement, de la manière la plus simple, en partageant sur les réseaux sociaux.

Health Canada Canada CA9600871 CA9600871 Diagnostic x-ray equipment compliance

Health Canada Canada CA9600871 CA9600871 Diagnostic x-ray equipment compliance and facility survey Canada Diagnostic x-ray equipment compliance and facility survey Recommended procedures for equipment and facility testing Environmental Health Directorate Health Protection Branch Published by Authority of the Minister of National Health and Welfare Egalement disponible en francais sous le titre "Inspection des installations et de I'equipement de radiodiagnostic. Techniques recommandees pour la mise a I'essai de I'equipement et des installations" 94-EHD-184 © Minister of Supply and Services Canada 1994 Available in Canada through your local bookseller or by mail from: Canada Communication Group — Publishing Ottawa, Canada K1A 0S9 Cat. No. H46-2/94-184E ISBN 0-660-15499-4 Canadian Cataloguing in Publication Data Main entry under title: Diagnostic X-Ray Equipment Compliance and Facility Survey — Recommended Procedures for Equipment and Facility Testing Publ. aussi disponible en francais sous le titre: Inspection des installations et de I'equipement de radiodiagnostic Cat. No. H46-2/94-184E ISBN 0-660-15499-4 1. Radiography, Medical — Safety measures. 2. X-Rays — Equipment and Supplies — Safety measures. I. Canada. Environmental Health Directorate. RC78.5D52 1994 616.07'572 C94-980209-3 Explanatory notes This document was prepared by the Radiation Protection Bureau. It sets out guidelines for the testing of diagnostic x-ray equipment and facilities1. This guide provides information for the X-ray inspector, test engineer, technologist, medical physicist and any other person responsible for verifying the regulatory compliance or safety of diagnostic x-ray equipment and facilities. The radiation protection surveys detailed in this guide are primarily for the guidance of persons employed in the Federal Public Service Departments and Agencies including those persons under the juris- diction of the Canada Labour Code. This guide also is intended to assist other users and manufacturers of x-ray equipment used for general patient diagnosis. However, it is important to recognize that facilities under provincial jurisdiction are subject to requirements specified under provincial statutes. Contact the appropriate authority listed in Appendix III for details of the regulatory requirements of individual provinces. The words "must", "shall" and "should" in this guide have been chosen with purpose. The words "must" and "shall" indicate a requirement that is essential to meet the currently accepted standards of protection, while "should" indicates an advisory recommendation that is highly desirable and should be implemented where feasible. In a field in which technology is advancing rapidly and where unexpected and unique problems continually occur the guide cannot cover all possible situations. Regulatory requirements may be modified and risks connected with x-radiation reassessed at any time. Blind adherence to rules cannot substitute for sound judgement. Therefore, recommendations may be modified in unusual circumstances, but only upon the advice of experts with recognized competence in radiation protection. This guide will be reviewed and revised peri- odically. Obtain interpretation or elaboration of any point by contacting the Bureau of Radiation Protection, Health Canada, 775 Brookfield Road Ottawa, Ontario K1A 1C1. This guide reflects the results of the work of many individuals. It was prepared and compiled by Paul Chaloner, and reviewed by the professional and technical staff of the X-Ray Section, Radiation Protection Bureau, prior to publication. Appreciation is expressed to all organizations, agencies and individuals whose comments and suggestions helped in the prepara- tion of this guide. Originally referred to as Safety Code RPB-SC-20B (in Safety Code 20A - X-ray Equipment in Medical Diagnosis Part A, 1990). NEXT left BLANK Contents page 1. Introduction 7 2. Principal aims and scope of the guide 8 2.1 Principal aims 8 2.2 Scope 8 3. Responsibility and personnel 9 3.1 Responsibility 9 3.2 Personnel 9 4. Radiation protection surveys 10 4.1 General Information 10 4.2 X-ray equipment compliance tests 11 1) Reproducibility of exposure 11 2) Timing device accuracy 13 3A) Minimum loading time 15 3B) Minimum automatic exposure control time 17 4) Average exposure ratios (linearity) 19 5) X-ray tube voltage accuracy 21 6) Beam quality 22 7A) Leakage radiation from the x-ray tube housing (Field Testing) 25 7B) Leakage radiation from the x-ray tube housing (Laboratory Testing) 27 8) Radiation beam transmission through the mammographic image receptor support device 29 9A) Standby radiation from capacitor energy storage equipment 31 9B) Leakage radiation from capacitor energy storage equipment 33 10) Alignment and size comparison of the x-ray and light fields 35 11) Beam limiting device for general purpose x-ray equipment ' 38 12) Light localizer illumination 42 13A) Target-to-table top distance for under-table x-ray tubes 43 13B) Target-to-image receptor distance for over-table x-ray tubes 45 14) Beam limiting device for mammographic equipment 47 15) Beam limiting device for use with only one size of image receptor and a fixed target-to-image receptor distance 49 16A) Maximum fluoroscopic exposure rate at the table top for under-table x-ray tubes 51 16B) Maximum fluoroscopic exposure rate at 30 cm above the table top for over-table x-ray tubes 53 17A) Spot film device for under-table x-ray tubes 55 17B) Spot film device for over-table x-ray tubes 58 18A) Beam limiting device for under-table fluoroscopic x-ray tubes 60 18B) Beam limiting device for over-table fluoroscopic x-ray tubes 62 19) Image intensifier and shielding interlocks for fluoroscopic under-table x-ray tubes 64 4.3 Facility testing 66 4.4 Verification of the adequacy of the shielding 69 Appendix I Survey equipment 72 Appendix II Recommended dose limits of X-radiation to operators and other occupationally exposed personnel 73 Appendix III Agencies responsible for radiation safety of medical x-ray installations 75 Appendix IV Survey forms 79 Appendix V Sample calculations 95 Appendix VI Glossary of Terminology 98 1. Introduction Diagnostic x-radiation is an essential part of present day medical practice. The largest contributor of irradiation to the general popu- lation comes from diagnostic x-radiation. Although individual irra- diations are usually small, there is a concern of possible excess cancer risk when large populations are irradiated. Unnecessary irradiations to patients from radiological procedures can be significantly reduced with little or no decrease in the value.of medical diagnostic information. This can be achieved by using well designed x-ray equipment which is installed, used and maintained by trained personnel, and by the adoption of standardized procedures. In general, when patient surface dose is reduced, there is a corresponding decrease in dose to x-ray equipment operators and other health care personnel. The need for radiation protection exists because exposure to ionizing radiation can cause deleterious effects in both the exposed individual and in descendants. Such effects are called somatic and genetic effects, respectively. Somatic effects are characterized by adverse changes occurring in the body organs of the individual exposed. Genetic effects are attributed to chromosomal damage of the germ cells and may give rise to genetic defects that may show themselves in the progeny of exposed individuals. While for radiation workers and the public permissible equiva- lent dose limits have been defined, only guidelines for the recommended upper limits on surface dose have been set for patients undergoing diagnostic x-ray procedures. For patients, the risk involved in the irradiation must always be weighed against the benefit of accurate medical diagnosis. However, consistent with quality images, there must always be a conscious effort to reduce irradiation to the lowest practical levels and eliminate unnecessary irradiation. 2. Principal aims and scope of the guide This guide provides details on the testing of diagnostic x-ray equipment and survey procedures of the facility. 2.1 Principal aims The principal aims of this guide are to outline survey procedures and list the measurements required for specific types of equipment and facilities. 2.2 Scope To assist personnel in achieving these aims this guide: 1. details tests for diagnostic x-ray equipment; 2. identifies the relevant section of the regulations pertinent to the test being performed; 3. itemizes how to evaluate the results of the tests; and 4. specifies the acceptance criteria by which the equipment will be judged. 3. Responsibility and personnel 3.1 Responsibility The owner is ultimately responsible for the radiation safety and operation of a diagnostic x-ray facility. The owner may delegate responsibility to staff. (For more information about the responsibili- ties of the Responsible user and the Radiation Protection (Safety) Officer see Safety Code 20A.) The equipment manufacturer or importer is responsible for offering for sale only equipment that meets all applicable require- ments under the Radiation Emitting Devices Act and Regulations. If equipment is modified by a person or persons who are at arm's length from the owner and the modification results in equipment which is non-compliant, then the person or persons paid for the work are considered manufacturers. That person or company has the same responsibility as if they supplied the original equipment in question. Similarly, the vendor of used equipment has to ensure that all regulatory requirements are met before the equipment can be used by the new owner. Some tests may be detrimental to the x-ray equipment. Therefore it is the responsibility of those performing the tests to follow the manufacturer's specifications for equipment warm-up and operating conditions. 3.2 Personnel Personnel performing equipment testing and evaluation of results should have adequate training and experience in radiation safety. A proven ability to perform the tests is necessary. A program for uploads/Sante/ x-ray-guide.pdf