1、BRITISH STANDARD BS 5724-2.15: 1989 IEC 601-2-15: 1988 Incorporating Amendment No. 1 Medical electrical equipment Part 2: Particular requirements for safety Section 2.15 Specification for capacitor discharge X-ray generators (Implementation of CENELEC HD395.2.15 S1) UDC 615.47:62-83:621.31 + 615+849
2、.114+621.313:613.647.614.825BS5724-2.15:1989 This British Standard, having been prepared under the directionof the Health CareStandards Policy Committee,waspublished underthe authorityof the BoardofBSI andcomes into effect on 31 October 1989 BSI 09-1999 The following BSI references relate to the wor
3、k on this standard: Committee reference HCC/75 Draft for comment 85/52864 DC ISBN 0 580 17627 4 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/75, upon which the
4、following bodies were represented: Association of X-ray Equipment Manufacturers (BEAMA Ltd) British Dental Association British Institute of Radiology British Society of Dental and Maxillofacial Radiology College of Radiographers Department of Health Institute of Physical Sciences in Medicine (Ipsm)
5、Society of X-ray Technology Amendments issued since publication Amd. No. Date of issue Comments 6989 April 1992 Indicated by a sideline in the marginBS5724-2.15:1989 BSI 09-1999 i Contents Page Committees responsible Inside front cover National foreword iv Section 1. General 1 Scope and object 1 1.1
6、 Scope 1 1.2 Object 1 1.3 Particular Standards 2 1.4 Environmental conditions 2 2 Terminology and definitions 2 2.12 Miscellaneous 2 3 General requirements 3 3.101 Conventional meanings of electrical quantities 3 3.102 Radiation quantities 3 4 General requirements for tests 3 4.1 Type tests and rout
7、ine tests 3 4.10 Moisture pre-conditioning treatment 3 5 Classification 3 6 Identification, marking and documents 4 6.1 Marking on the outside of equipment or equipment parts 4 6.2 Marking on the inside of equipment or equipment parts 5 6.7 Indicator lights and push buttons 5 6.8 ACCOMPANYING DOCUME
8、NTS 5 7 Power input 8 Section 2. Safety requirements 8 Basic safety categories 8 9 Removable protective means 8 10 Special environmental conditions 8 11 Special measures with respect to safety 8 12 SINGLE FAULT CONDITION 8 Section 3. Protection against electric shock hazards 13 General 8 14 Requirem
9、ents related to classification 8 15 Limitation of voltage and/or current 8 16 Enclosures and PROTECTIVE COVERS 9 17 Insulation and PROTECTIVE IMPEDANCES 9 18 Earthing and potential equalization 9 19 Continous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 9 19.3 Allowable values 9 20 Dielectric str
10、ength 10 20.3 Values of test voltages 10 20.4 Tests 10 Section 4. Protection against mechanical hazards 21 Mechanical strength 10 22 Moving parts 10 23 Surfaces, corners and edges 10 24 Stability and transportability 11 25 Expelled parts 11 26 Vibration and noise 11BS5724-2.15:1989 ii BSI 09-1999 Pa
11、ge 27 Pneumatic and hydraulic power 11 28 Suspended masses 11 Section 5. Protection against hazards from unwanted or excessive radiation 29 X-radiation 11 29.1 X-RADIATION generated by diagnostic CAPACITOR DISCHARGE X-RAY GENERATORS 11 30 Alpha, beta, gamma, neutron radiation and other particle radi
12、ation 13 31 Microwave radiation 13 32 Light radiation (including visual radiation and lasers) 13 33 Infra-red radiation 13 34 Ultra-violet radiation 13 35 Acoustical energy (including ultrasonics) 13 36 Electromagnetic compatibility 13 Section 6. Protection against hazards of explosions in medically
13、 used rooms 37 General 13 38 Classification, marking and ACCOMPANYING DOCUMENTS of ANAESTHETIC-PROOF EQUIPMENT 13 39 Common requirements for “AP” and “APG” equipment 13 40 Requirements and tests for ANAESTHETIC-PROOF EQUIPMENT, equipmentparts or components (AP) 14 41 Requirements and tests for ANAES
14、THETIC-PROOF CATEGORY G EQUIPMENT, equipment parts or components 14 Section 7. Protection against excessive temperatures, fire and other hazards,such as human errors 42 Excessive temperatures 14 42.1 Addition 14 42.5 Guards 14 43 Fire prevention 14 44 Overflow, spillage, leakage, humidity, ingress o
15、f liquids, cleaning, sterilization and disinfection 14 45 Pressure vessels and parts subject to pressure 14 46 Human errors 14 47 Electrostatic charges 14 48 Materials in APPLIED PARTS in contact with the body of the PATIENT 14 49 Interruption of the power supply 14 Section 8. Accuracy of operating
16、data and protection against incorrect output 50 Accuracy of operating data 15 50.1 Indication of electric and radiation output 15 50.101 Reproducibility of radiation output 15 50.102 Agreement between indicated and measured values of LOADING FACTORS 15 50.103 Correction for fluctuations of MAINS VOL
17、TAGE 16 50.104 Test conditions 16 50.105 General 17 50.106 Methods of measuring LOADING FACTORS 17 50.107 Conditions for measuring AIR KERMA 18BS5724-2.15:1989 BSI 09-1999 iii Page 50.108 Combination of LOADING FACTORS for the determination of COEFFICIENT OF VARIATION 19 50.109 Combination of LOADIN
18、G FACTORS for the determination of PER CENT AVERAGE ERROR 19 51 Protection against incorrect output 19 Section 9. Fault conditions causing overheating and/or mechanical damage;environmental tests 52 Fault conditions causing overheating and/or mechanical damage 20 53 Environmental tests 20 Section 10
19、. Constructional requirements 54 General 20 55 Enclosures and covers 20 56 Components and general assembly 20 56.8 Indicators 20 56.11 Switches 20 57 MAINS PARTS, components and layout 20 57.1 Separation from the SUPPLY MAINS 20 57.9 Mains supply transformers and MEDICAL ISOLATING TRANSFORMERS 21 57
20、.10 CREEPAGE DISTANCES and AIR CLEARANCES 21 58 PROTECTIVE EARTH TERMINALS 21 59 Construction and layout 21 59.4 Oil containers 21 Appendix AA Terminology 22 Appendix AA.2 Alphabetical index of English terms 22 Informative annex to HD 395.2.15 S1 Figure 101 TOTAL FILTRATION for the measurement of AI
21、R KERMA 18 Table 101 Permissible PER CENT AVERAGE ERROR of LOADING FACTORS 16 Publications referred to Inside back coverBS5724-2.15:1989 iv BSI 09-1999 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is identical with IE
22、CPublication601-2-15:1988 “Medical electrical equipment” Part 2 “Particular requirements for the safety of capacitor discharge X-ray generators”, prepared by Technical Committee TC62 Electrical equipment in medical practice of the International Electrotechnical Commission (IEC). This Particular Stan
23、dard amends and supplements BS5724-1 hereinafter called the General Standard. As stated in1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. This Section of BS5724 is also in agreement with Harmonization Document HD395.2.15S1
24、, published by the European Committee for Electrotechnical Standardization (CENELEC). As in the General Standard, the requirements are followed by compliance tests. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, su
25、bclauses or figures that are additional to those of the General Standard are numbered starting from101; the additional appendix is letteredAA. The changes from the text of the General Standard are specified by the use of the following words. “Replacement” means that the clause, subclause or specifie
26、d paragraph of the General Standard is replaced by the text of this standard. “Amendment” means that the clause, subclause or specified paragraph of the General Standard is amended as indicated by the text of this standard. “Addition” means that the text of this standard is additional to the require
27、ments of the General Standard. The text of the International Standard has been approved as suitable for publication as a British Standard without deviation. Some terminology and certain conventions are not identical with those used in British Standards. In particular the following print types are us
28、ed. Requirements, compliance with which can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defined in clause2 of the General Standard, in BS6641 and in this Particular Standar
29、d: small capitals. NOTEAppendix AA is omitted since it is essentially the French alphabetical index with an English translation. Appendix AA.2, the English alphabetical index, is retained but without the French translation. Cross-references International Standard Corresponding British Standard IEC 4
30、17G:1985 BS 6217:1981 Guide to graphical symbols for use on electrical equipment (Identical) BS5724 Medical electrical equipment IEC 601-1:1977 a as amended by AmendmentNo.1(1984) Part 1:1979 Specification for general safety requirements (Technically equivalent) IEC 601-2-7:1987 Part 2 Particular re
31、quirements for safety Section 2.7:1987 Specification for high-voltage generators of diagnostic X-ray generators (Identical) IEC 637:1979 BS 6059:1981 Specification for essential data to be supplied with X-ray tubes and X-ray tube assemblies for medical use (Identical) a The 1977 edition of IEC 601-1
32、 has been superseded by IEC601-1:1988 and the corresponding British Standard for this revision is BS5724-1:1989.BS5724-2.15:1989 BSI 09-1999 v There are no corresponding British Standards to IEC407:1973 “Radiation protection in medical X-ray equipment10kV to400kV” or to IEC407A:1975 “First supplemen
33、t to Publication407 (1973): Subclause7.5.5: Equipment for dental radiography”, which are partially superseded by this Particular Standard. The general requirements of IEC407 and IEC407A are being replaced by IECPublication601-1- “Complement to Part1: General requirements for protection against ioniz
34、ing radiation from diagnostic X-ray equipment”. The requirements of IEC407 andIEC407A relating to particular equipments are being replaced by requirements incorporated in Particular Standards. IEC601-1- is referred to in this Particular Standard as “the Collateral Standard: General Requirements for
35、the Protection against Ionizing Radiation (under consideration)”, the latest draft of which is document IEC62B (Secretariat)91. It is expected that a British Standard corresponding to IEC601-1- will be prepared when the IEC standard is published. ICRP Publication26 referred to in this Particular Sta
36、ndard is prepared by the International Commission for Radiological Protection, Clifton Avenue, Sutton, SurreySM25PU, and is available from Pergamon Press Ltd, Headington Hill Hall, OxfordOX30BW. A British Standard does not purport to include all the necessary provisions of a contract. Users of Briti
37、sh Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. International Standard Corresponding British Standard IEC 664:1980 PD 6499:1981 Guide to insulation co-ordination within low-voltage systems inclu
38、ding clearances and creepage distances for equipment (Identical) IEC 664A:1981 PD 6499:1981 Guide to insulation co-ordination within low-voltage systems including clearances and creepage distances for equipment Identical to Amendment No.1 (1987) IEC 788:1984 BS 6641:1985 Glossary of medical radiolog
39、y terms (Identical) Summary of pages This document comprises a front cover, an inside front cover, pagesi tovi, pages1to24, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment tab
40、le on the inside front cover.vi blankBS5724-2.15:1989 BSI 09-1999 1 Section 1. General 1 Scope and object This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Particular Standard applies to CAPACITOR DISCHARGE X-RAY GENERATORS operating in INTERMITTENT MODE for me
41、dical RADIOGRAPHY, in which the electrical energy for LOADING of the X-RAY TUBE is completely or mainly capacitively stored at, and switched in, the high-voltage circuit. This Particular Standard is confined to those devices which are MEDICAL ELECTRICAL EQUIPMENT and in which the storage capacitor i
42、s in the high-voltage circuit and has a specified capacitance not exceeding24F, the INITIAL X-RAY TUBE VOLTAGE is between40kV and150kV, an overcurrent protection, if provided, would not require a rating exceeding that which corresponds to an apparent power of3kVA, LOADING of the X-RAY TUBE is contro
43、lled in the high-voltage circuit. This Particular Standard does not exclude CAPACITOR DISCHARGE X-RAY GENERATORS that are capable of operation in CONTINUOUS MODE for DIRECT RADIOSCOPY or INDIRECT RADIOSCOPY. However, for this mode of operation the device will have to comply with the relevant require
44、ments for diagnostic HIGH-VOLTAGE GENERATORS and diagnostic X-RAY EQUIPMENT (seeSub-clause1.3.102). 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. Req
45、uirements for reproducibility and accuracy are given because of their relationship to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered necessary for safety. Rationale. Both the levels for compliance and the tests prescribed to determine compliance refl
46、ect the fact that the safety of CAPACITOR DISCHARGE X-RAY GENERATORS is not sensitive to small differences in levels of performance. The combinations of LOADING FACTORS specified for the tests are therefore limited in number but are chosen from experience as being appropriate in most cases. It is co
47、nsidered important to standardize the choice of combinations of LOADING FACTORS so that comparison can be made between tests performed in different places on different occasions. However, combinations other than those specified could be of equal technical validity. NOTE 1The safety philosophy on whi
48、ch this Particular Standard is based is described in the Introduction to the General Standard (seeSub-clause1.3.101). NOTE 2With respect to protection against IONIZING RADIATION, this Particular Standard deals with indirect aspects of safety, namely those that depend upon the supply and control of e
49、lectric energy from the CAPACITOR DISCHARGE HIGH-VOLTAGE GENERATOR. Direct requirements for protection against IONIZING RADIATION are given in the Collateral Standard referenced in Sub-clause1.3.102. NOTE 3Concerning RADIOLOGICAL PROTECTION, it has been assumed in the preparation of this Particular Standard that USERS of medical diagnostic X-RAY EQUIPMENT will accept the basic recommendations of the International Commission on Radiological Protection (ICRP), as stated in ICRPPublication26,1977, paragraph12, namely: “a) no practice shall be adopted unless
