BS EN 60601-2-8-1998 Medical electrical equipment - Particular requirements for safety - Specification for therapeutic X-ray equipment operating in the range 10 kV to 1 MV《医用电气设备 安.pdf

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1、BRITISH STANDARD BS EN 60601-2-8:1998 IEC 60601-2-8: 1987 incorporating IEC60601-2-8/A1: 1997 BS 5724-2-8: 1998 incorporating Corrigendum No. 1 Medical electrical equipment Part 2: Particular requirements for safety Section 2.8 Specification for therapeutic X-ray equipment operating in the range 10k

2、V to 1MV The European Standard EN 60601-2-8:1997 including EN 60601-2-8/A1:1997 has the status of a British Standard ICS 11.040.50BS EN60601-2-8:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the S

3、tandards Board and comes into effect on 15 May 1998 BSI 07-1999 ISBN 0 580 28558 8 Amendments issued since publication Amd. No. Date Comments 10098 Corr.No.1 November 1998 See national forewordBS EN60601-2-8:1998 BSI 07-1999 i Contents Page National foreword ii Foreword 2 Text of EN 60601-2-8 7BS EN

4、60601-2-8:1998 ii BSI 07-1999 National foreword This British Standard is the English language version of EN60601-2-8:1997. It is identical with IEC60601-2-8:1987 including IEC60601-2-8/A1:1997 (both of which have now been adopted by CENELEC). It supersedes BS5724-2.8:1987 which is withdrawn. Corrige

5、ndum No. 1 has been produced to correct errors introduced in interpreting the IEC amendment instructions. Subclauses 50.1.101 to 50.104.3 have been renumbered as Subclauses 29.103.1 to 29.108.3 and the term “X-RAY GENERATOR” has been replaced by “X-RAY EQUIPMENT”. The UK participation in its prepara

6、tion was entrusted to Technical Committee CH/81, Radiotherapy equipment, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed

7、; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC27-1 h

8、as been renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative

9、 references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by us

10、ing the “Find” facility of the BSI Standards Electronic Catalogue. Additional information Subclauses, figures or tables that are additional to those of BS5724-1 (the General Standard) are numbered starting from 101; additional annexes are lettered AA, etc. and additional items aa), bb), etc. Annex A

11、A is for information only. Annex BB forms an integral part of this standard. The following print types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman typ

12、e. Test procedures: in italic type. Terms defined in this Particular Standard which have been listed in Annex AA and defined in clause 2, or in the General Standard and its Collateral Standards or in BS6641: SMALL CAPITALS. A British Standard does not purport to include all the necessary provisions

13、of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pag

14、es 2 to 34, 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 table on theinside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-8 September 1997 + A1 S

15、eptember 1997 ICS 11.040.50 Supersedes HD 395.2.8 S1:1988 Descriptors: Medical electrical equipment, X-ray equipment, therapeutic X-ray generators, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental condi

16、tions English version Medical electrical equipment Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10kV to 1MV (includes amendment A1:1997) (IEC60601-2-8:1987 + A1:1997) Appariels lectromdicaux Partie 2: Rgles particulieres de scurit pour les quip

17、ements rayonnement X de thrapie fonctionnant dans la gamme de 10 kV 1MV (inclut lamendement A1:1997) (CEI 60601-2-8:1987 + A1:1997) Medizinische elektrische Gerte Teil 2: Besondere Festlegungen fr die Sicherheit von Therapie-Rntgeneinrichtungen im Betreibsbereich von 10kV bis 1MV (enhlt nderung A1:1

18、997) (IEC 60601-2-8:1987 + A1:1997) This European Standard was approved by CENELEC on 1997-07-01; amendment A1 was approved by CENELEC on 1997-07-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the sta

19、tus of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German)

20、. A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Fi

21、nland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische

22、Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1997 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members Ref. No. EN 60601-2-8:1997 + A1:1997 EEN60601-2-8:1997 BSI 07-1999 2 Foreword The text of the International Standard IEC60601-2

23、-8:1987, prepared by SC62B, Diagnostic imaging equipment, of IEC TC62, Electrical equipment in medical practice, was approved by CENELEC as HD395.2.8 S1:1988 on 1988-06-28. This Harmonization Document was submitted to the formal vote for conversion into a European Standard and was approved by CENELE

24、C as EN60601-2-8 on1997-07-01. The following date was fixed: Subclauses, tables and figures which are additional to those in part 1 are numbered starting from 101. Annexes which are additional to those in part 1 are lettered AA, BB, etc. and additional items aa), bb), etc. Foreword to EN60601-2-8:19

25、97/A1: 1997 The text of document 82C/186/FDIS, future amendment 1 to IEC60601-2-8:1987, prepared by SC62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by C

26、ENELEC as amendment A1 to EN60601-2-8:1987 on 1997-07-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex BB and Annex ZA are normative and Annex AA and Annex

27、 ZB are informative. Annex ZA and Annex ZB have been added by CENELEC. Endorsement notice The text of amendment1:1997 to the International Standard IEC60601-2-8:1987 was approved by CENELEC as an amendment to the European Standard without any modification. latest date by which the EN has to be imple

28、mented at national level by publication of an identical national standard or by endorsement (dop)1998-06-01 latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement (dop)1998-06-01 latest date by which the national

29、standards conflicting with the amendment have to be withdrawn (dow)1998-06-01EN60601-2-8:1997 BSI 07-1999 3 Contents Page Foreword 2 Introduction 7 Section 1. General 1 Scope and object 7 1.1 Scope 7 1.2 Object 7 1.3 Particular standards 7 1.3.101 Relation to the General Standard 7 1.3.103 IEC 61217

30、 7 1.5 Collateral Standards 8 1.5.101 IEC 60601-1-1 8 1.5.102 IEC 60601-1-2 8 1.5.103 IEC 60601-1-3 8 1.5.104 IEC 60601-1-4 8 2 Terminology and definitions 8 3 General requirements 8 3.101 Conventional meaning of electrical quantities 8 4 General requirements for tests 8 4.1 Tests 8 4.1.101 Test gra

31、des 8 4.6 Other conditions 8 4.7 Supply and test voltages, type of current, nature of supply, frequency 9 5 Classification 9 6 Identification, marking and documents 9 6.1 Marking on the outside of the EQUIPMENT or EQUIPMENT parts 9 6.2 Marking on the inside of equipment and equipment parts 10 6.3 Ma

32、rking of controls and instruments 10 6.3.101 Provisions of scales and indications for moving parts 10 6.7 Indicator lights and push-buttons 10 6.8 ACCOMPANYING DOCUMENTS 10 6.8.1 General 10 6.8.2 INSTRUCTIONS FOR USE 11 6.8.3 Technical description 11 6.8.101 Statement of compliance 11 7 Power input

33、11 Section 2. Environmental conditions 8 Basic safety categories 11 9 Removable protective means 11 10 Special environmental conditions 11 Page 11 Special measures with respect to safety 11 12 SINGLE FAULT CONDITION 11 Section 3. Protection against electric shock hazards 13 General 11 14 Requirement

34、s related to classification 11 15 Limitation of voltage and/or current 11 16 Enclosures and PROTECTIVE COVERS 12 17 Insulation and PROTECTIVE IMPEDANCES 12 18 Protective earthing, functional earthing and potential equalization 12 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 12 19.3

35、Allowable values 12 20 Dielectric strength 13 20.3 Values of test voltages 13 20.4 Tests 13 Section 4. Protection against mechanical hazards 21 Mechanical strength 13 22 Moving parts 13 23 Surfaces, corners and edges 13 24 Stability in NORMAL USE 13 25 Expelled parts 13 26 Vibration and noise 13 27

36、Pneumatic and hydraulic power 13 28 Suspended masses 13 Section 5. Protection against hazards from unwanted or excessive radiation 29 X-radiation 13 29.1 X-RADIATION generated by therpeutic X-RAY GENERATORS 13 29.1.101 Limitation of LEAKAGE RADIATION from the X-RAY SOURCE ASSEMBLY during treatments

37、13 29.1.102 Limitation of LEAKAGE RADIATION and unwanted RADIATION from the X-RAY SOURCE ASSEMBLY at times other than during treatments 14 29.1.103 Limitation of unwanted RADIATION from the X-RAY SOURCE ASSEMBLY with BEAM LIMITING DEVICES or therapeutic BEAM APPLICATORS 15EN60601-2-8:1997 BSI 07-199

38、9 4 Page 29.1.104 Limitation of RADIATION from parts other than the X-RAY SOURCE ASSEMBLY 16 29.1.105 Control of IRRADIATION 16 29.1.106X-RAY SOURCE ASSEMBLIES designed and specified to be held by hand 17 29.1.107 Marking of PROTECTIVE DEVICES 17 29.1.108 Condition for READY STATE 17 29.101.1 Limita

39、tion of ABSORBED DOSE 17 29.101.2 Selection of IRRADIATION time or DOSE MONITORING UNITS 17 29.101.3 DISPLAY of preselected IRRADIATION time or DOSE MONITORING UNITS 17 29.101.4 System design 17 29.101.5 DISPLAY of IRRADIATION time or DOSE MONITORING UNITS 18 29.101.6 Control of IRRADIATION 18 29.10

40、1.7Control of IRRADIATION in MOVING BEAM RADIOTHERAPY 19 29.102SINGLE FAULT CONDITION 19 29.102.1List of specific SINGLE FAULT CONDITIONS 19 29.102.2 Protection against failure of termination 19 29.102.3 Protection against failure of movement 20 29.102.4 Stand-by with energized X-RAY TUBE 20 29.102.

41、5 Removable ADDED FILTERS 20 29.102.6 Removable therapeutic BEAM APPLICATORS with fixed ADDED FILTERS 20 29.102.7 Indications of SINGLE FAULT CONDITIONS 21 29.103 Indication of X-RADIATION output 21 29.104 Agreement between indicated values and effective values 22 29.105 General test conditions 22 2

42、9.106 Settings for measurements 23 29.107 Number of measurements 23 29.108 Measurements and evaluation 23 30 Alpha, beta, gamma, neutron radiation and other particle radiation 25 31 Microwave radiation 25 32 Light radiation (including visible radiation and lasers) 25 33 Infra-red radiation 25 34 Ult

43、ra-violet radiation 25 Page 35 Acoustical energy (including ultrasonics) 25 36 Electromagnetic compatibility 25 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures Section 7. Protection against excessive temperatures and other safety hazards 42.4 Compliance tests 25 4

44、3 Fire prevention 25 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 25 45 Pressure vessels and parts subject to pressure 25 46 Human errors 25 47 Electrostatic charge 25 48 Biocompatibility 25 49 Interruption of the power supply 25 Section 8. A

45、ccuracy of operating data and protection against hazardous output 50 Accuracy of operating data 25 51 Protection against hazardous output 25 Section 9. Abnormal operation and fault conditions, envoronmental tests 52 Abnormal operation and fault conditions 25 52.1 Replacement 25 53 Environmental test

46、s 26 Section 10. Constructional requirements 54 General 26 55 Enclosures and covers 26 56 Components and general assembly 26 57 MAINS PARTS, components and layout 26 58 PROTECTIVE EARTH TERMINALS 26 59 Construction and layout 26 59.4 Oil containers 26 Annex AA Terminology 27 Annex BB (normative) Lis

47、t of standards mentioned in this Particular Standard 33 Annex ZA (normative) Normative references to international publications with their corresponding European publications 34EN60601-2-8:1997 BSI 07-1999 5 Page Annex ZB (informative) Other references to international publications with their corres

48、ponding European publications Inside back cover Table 101 Permissible LEAKAGE RADIATION 14 Table 102 Permissible LEAKAGE RADIATION from X-RAY SOURCE ASSEMBLIES with BEAM LIMITING DEVICES or therapeutic BEAM APPLICATORS 15 Table 104 Correspondence between old and new subclause numbers 24EN60601-2-8:1

49、997 6 BSI 07-1999 Foreword 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international cooperation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee inte