1、BRITISH STANDARD BS 7725-1: 1994 IEC 1223-1: 1993 Evaluation and routine testing in medical imaging departments Part 1: GeneralBS7725-1:1994 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standar
2、ds Board and comes intoeffect on 15 February 1994 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/73 Draft for comment 87/50926 DC ISBN 0 580 22796 0 Committees responsible for this British Standard The preparation of this British Standard was en
3、trusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/73, upon which the following bodies were represented: British Institute of Radiology College of Radiographers Department of Health Institute of Physical Sciences in Medicine (IPSM) Royal College of Radiologists
4、Society of X-ray Technology Amendments issued since publication Amd. No. Date CommentsBS7725-1:1994 BSI 10-1999 i Contents Page Committees responsible Inside front cover National foreword ii Introduction 1 1 Scope and object 1 2 References to other publications 2 3 Terminology 2 4 Quality assurance:
5、 Quality control and quality administration 2 5 Action to be taken 6 6 Assessing the effectiveness of the quality assurance programme 6 7 Subjects for constancy tests 7 Annex A Terminology Index of terms 9 Annex B Bibliography 10 Figure 1 Scheme for checking the performance of a diagnostic X-ray ins
6、tallation 8 Table 1 Types of performance tests 7 List of references Inside back coverBS7725-1:1994 ii BSI 10-1999 National foreword This Part of BS 7725 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with IEC Publication 1223-1:1993 Evaluation an
7、d routine testing in medical imaging departments Part1:General aspects, prepared by the Technical Committee 62 Electrical equipment in medical practice and published by the International Electrotechnical Commission (IEC). NOTEISO 8402:1986 referenced in clause 2 is not quoted in this technical repor
8、t. This error has been reported to the relevant body for action. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity
9、from legal obligations. Cross-references International Standard Corresponding British Standard IEC 601-1:1988 BS 5724 Medical electrical equipment Part 1:1989 General requirements for safety (Identical) IEC 788:1984 BS 6641:1985 Glossary of medical radiology terms (Identical) IEC 1223-2-1:1993 BS 77
10、25 Evaluation and routine testing in medical imaging departments Section 2.1:1994 Method for film processors (Identical) Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages1 to 12, an inside back cover and a back cover. This standard has been updated
11、(see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.BS 7725-1:1994 BSI 10-1999 1 Introduction In recent years, QUALITY ASSURANCE PROGRAMMES have been initiated in several countries mostly on a local basis, sometimes o
12、n a national level with the purpose of either maintaining or improving the quality of daily operations in diagnostic X-ray departments. As far as these operations depend on the use of equipment, and as part of an international effort towards a more uniform approach in this field, the IEC issues Part
13、icular Publications (International Standards or technical reports) which describe the methods and provide the guidelines for establishing QUALITY ASSURANCE PROGRAMMES for individual items of equipment or systems of equipment in a diagnostic X-ray department. An effective QUALITY ASSURANCE PROGRAMME
14、will help to achieve and maintain: radiological information of adequate quality for medical diagnostic purposes; minimum radiation dose to the PATIENT and medical staff, compatible with adequate quality of the radiological information; maximum cost containment by minimizing wastage of time and resou
15、rces (for example reduction of rejected RADIOGRAMS). Benefits arise also through the enhancement of the professional and public reputation of the department. The Particular IEC Publications (International Standards or technical reports) describing guidelines for establishing effective QUALITY ASSURA
16、NCE PROGRAMMES are concerned with test methods for monitoring the imaging performance of equipment. To encourage the adoption of these test methods in a large number of diagnostic X-ray departments, emphasis is placed upon test methods suitable to be carried out by OPERATORS involved in the daily us
17、e of the equipment. Effective activities for QUALITY ASSURANCE depend on quality administrative elements as well as on QUALITY CONTROL techniques. Quality administrative elements ensure that testing is done by qualified personnel to an effective schedule; test results are analyzed to determine wheth
18、er problems exist; and appropriate corrective action is undertaken where necessary. QUALITY CONTROL techniques comprise physical testing and monitoring of the functional performance of the equipment in order to determine whether or not corrective action is needed to adjust the equipment to maintain
19、the desired quality of the radiological information. The USER is responsible for preventive and corrective maintenance of the equipment in the diagnostic X-ray department. A QUALITY ASSURANCE PROGRAMME involves a continuous evaluation of the adequacy and effectiveness of QUALITY CONTROL. Both the QU
20、ALITY ASSURANCE PROGRAMME and QUALITY CONTROL should be reviewed and adjusted as appropriate to maintain continued effectiveness. 1 Scope and object 1.1 Scope This technical report applies to equipment and subassemblies forming those constituent components of diagnostic X-RAY INSTALLATIONS that gene
21、rate, influence the propagation of, and detect the X-RADIATION, and process, present and store the radiological information. 1.2 Object This technical report presents the concept of QUALITY ASSURANCE in diagnostic X-ray departments, and introduces a series of test methods to be carried out under the
22、 responsibility of the USER. The test methods introduced in this technical report are solely concerned with monitoring the constancy of functional performance of equipment and ASSOCIATED EQUIPMENT by means of test instrumentation and TEST DEVICES that are simple to use. The test methods are not inte
23、nded to deal with aspects of safety, such as mechanical and electrical safety, except where the intended function of the equipment or devices is to provide safety. The individual test methods for QUALITY CONTROL are described in, and published as, separate Particular IEC Publications. The individual
24、 tests carried out in a diagnostic X-ray department shall be linked to those aspects of a QUALITY ASSURANCE PROGRAMME, which are described in this technical report. This technical report is not intended to cover matters of clinical judgement in the management of the patient.BS7725-1:1994 2 BSI 10-19
25、99 2 References to other publications The following IEC/ISO publications are quoted in this technical report: IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. Amendment No. 1, 1991 IEC 788:1984, Medical radiology Terminology. IEC 1223-2-1:1993, Evaluation and rou
26、tine testing in medical imaging departments Part 2-1: Constancy tests Film processors. ISO 8402:1986, Quality Vocabulary. 3 Terminology 3.1 Use of terms In this technical report, terms printed in small capital letters are used as defined: in IEC 788; in IEC 1223-2-1; and in 3.2 of this part 1. (See
27、Annex A, Terminology Index of terms) 3.2 Definitions 3.2.1 QUALITY ASSURANCE planned and systematic actions necessary to provide adequate confidence by ensuring that a product or service will satisfy given requirements for quality 3.2.2 QUALITY ASSURANCE PROGRAMME detailed instruction for carrying o
28、ut actions of QUALITY ASSURANCE for individual items of equipment, systems of equipment or facilities, including quality administrative elements and QUALITY CONTROL techniques 3.2.3 QUALITY CONTROL operational techniques and activities that are used to fulfil requirements for quality 3.2.4 ACCEPTANC
29、E TEST test carried out after new equipment has been installed, or major modifications have been made to, existing equipment, in order to verify compliance with contractual specifications (see Table 1) 3.2.5 STATUS TEST test carried out to establish the functional status of equipment at a given time
30、 (see Table 1) 3.2.6 CONSTANCY TEST each of a series of tests, carried out: to ensure that the functional performance of equipment meets ESTABLISHED CRITERIA; or to enable the early recognition of changes in the properties of components of the equipment (see Table 1). 3.2.7 BASELINE VALUE reference
31、value of functional parameter: either the value obtained for this parameter in the initial CONSTANCY TEST immediately following a STATUS TEST; or where described in a corresponding Particular Standard, the mean value of values obtained in a series of initial CONSTANCY TESTS, immediately following a
32、STATUS TEST. 3.2.8 ESTABLISHED CRITERIA in a QUALITY ASSURANCE PROGRAMME, acceptable variations in results of a CONSTANCY TEST which signal satisfactory functional performance of the equipment tested 4 QUALITY ASSURANCE: QUALITY CONTROL and quality administration 4.1 General aspects There is increas
33、ed concern and awareness among users, manufacturers and competent authorities of the need for optimal use of resources and for ensuring that radiological information of adequate quality is produced in a diagnostic x-ray department, taking the radiation dose to the patient into account. This technica
34、l report emphasizes QUALITY CONTROL techniques and activities that monitor the constancy of the functional performance of the equipment. These techniques and activities should be carried out after the USER is satisfied that the functional performance of the diagnostic X-RAY INSTALLATION is acceptabl
35、e (for example, that it complies with the contractual specification). Prior to starting a series of CONSTANCY TESTS, the functional status of a diagnostic X-RAY INSTALLATION has to be established and documented. The results of the initial CONSTANCY TEST, or of the first series of initial CONSTANCY T
36、ESTS, constitute the BASELINE VALUES against which the results of all subsequent CONSTANCY TESTS are compared.BS 7725-1:1994 BSI 10-1999 3 Each result of a CONSTANCY TEST is related to ESTABLISHED CRITERIA. Taking into account the foreseen application of the equipment, applicable legal requirements,
37、 and the guidance in the Particular International Standards, the USER has to establish: the administrative measures to be followed; the values of the functional parameters to be used; other conditions to be observed for carrying out the CONSTANCY TESTS. Following practical experience, ESTABLISHED CR
38、ITERIA may have to be adjusted in order to be more appropriate under given conditions. The ESTABLISHED CRITERIA employed may vary with the type of equipment involved. Action shall be taken when results do not meet the ESTABLISHED CRITERIA. 4.2 Cost-benefit aspects Costs will include the purchase of
39、appropriate test instrumentation and TEST DEVICES, including consumable items; the down time of the equipment or facility under test; and the cost of staff time associated with testing, documenting and evaluating the test results. The anticipated benefits of a QUALITY ASSURANCE PROGRAMME are: mainte
40、nance of adequate imaging performance of the diagnostic X-RAY INSTALLATION; more effective and efficient use of the X-RADIATION delivered to the PATIENT; in connection with: reduction to a minimum of radiation dose to staff; capacity for higher patient throughput; lower consumption of RADIOGRAPHIC F
41、ILMS, chemicals, and other consumable items. 4.3 Technical aspects The quality of diagnostic images presented for interpretation depends in part on the functional performance of the diagnostic X-RAY INSTALLATION. Problems causing degradation of functional performance may occur in any component invol
42、ved in the imaging process, such as electrical controls, X-RAY SOURCE ASSEMBLIES, ANTI-SCATTER GRIDS, RADIOGRAPHIC CASSETTES, FILM PROCESSORS, darkrooms, and FILM ILLUMINATORS. The CONSTANCY TEST recommended in this technical report, and those described in detail in Particular International Standard
43、s, are based on the experience and expertise of manufacturers, competent authorities, and USERS. 4.4 Administrative aspects The quality administrative elements of a QUALITY ASSURANCE PROGRAMME provide the organizational framework to support, maintain and improve the conduct of QUALITY CONTROL techni
44、ques. Quality administrative elements ensure that problems related to image quality and radiation dose to PATIENT and staff are not only detected but also solved. Quality administrative elements allow the QUALITY ASSURANCE PROGRAMME to remain dynamic and responsive to changing needs of the diagnosti
45、c X-ray department. Planners of a QUALITY ASSURANCE PROGRAMME who fail to provide the few hours needed to administer each programme properly, risk the collapse of their programmes. Whereas the quality administrative elements of a QUALITY ASSURANCE PROGRAMME are generally the same in all facilities,
46、the methods of implementation vary among facilities of different size and differently equipped. The quality administrative elements of a programme are divided into two groups: those which provide a basis for the QUALITY ASSURANCE PROGRAMME; and those which allow the programme to remain dynamic and r
47、esponsive to changing needs. 4.4.1 Basic elements a) Responsibility Responsibility is assigned for every action that needs to be taken as a part of the QUALITY ASSURANCE PROGRAMME. Concurrent with that assignment goes the authority to take the necessary actions. It may be necessary to use outside pe
48、rsonnel if the expertise or staff required is not available within a facility. b) Purchase specifications Purchase specifications are developed well in advance of the purchase of equipment. As contractual specifications, they are the basis of the ACCEPTANCE TEST mentioned in 4.5.1. Purchase specific
49、ations should require the provision of ACCOMPANYING DOCUMENTS containing, in particular, INSTRUCTIONS FOR USE for all equipment and consumable items.BS7725-1:1994 4 BSI 10-1999 c) Records Records should be kept of any test related to a QUALITY ASSURANCE PROGRAMME. It is recommended that, whenever a QUALITY ASSURANCE PROGRAMME is based on periodic testing, evidence of the tests having been performed be given on the outside of the equipment tested; for example, by a label indicating the date of the next t
