EN 60601-2-1-1998 en Medical Electrical Equipment - Part 2-1 Particular Requirements for the Safety of Electron Accelerators in the Range of 1 MeV to 50 MeV (Incorporates Amendment.pdf

1、BRITISH STANDARD BS EN 60601-2-1:1998 IEC 60601-2-1:1998 BS 5724-2-1: 1998 Incorporating Amendment No. 1 Medical electrical equipment Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV The European Standard EN 60601-2-1:1998, with the incorporation

2、 of amendment A1:2002, has the status of a British Standard ICS 11.040.50; 13.280 BS EN 60601-2-1:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 Octo

3、ber 1998 BSI 5 August 2003 ISBN 0 580 29962 7 National foreword This British Standard is the English language version of EN 60601-2-1:1998, including amendment A1:2001. It is identical with IEC 60601-2-1:1998, including amendment 1:2002. It supersedes BS 5724-2-1:1989 and BS 5724-2-1-1:Supplement No

4、. 1:1991 which are withdrawn. As in the General Standard (BS 5724-1:1989), 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, Subclauses or Figures that are additional

5、 to those of the General Standard are numbered starting from 101. Additional annexes are lettered AA, BB, etc. and additional items aa), bb), etc. 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 spec

6、ified 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 req

7、uirements of the General Standard. The UK participation in its preparation 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 inter

8、pretation, or proposals for change, and keep the UK interests informed; 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

9、have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. 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 C

10、EN and CENELEC standards normally include an annex which lists normative 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 s

11、ection entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Additional information. The following print types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. E

12、xplanations, advice, general statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defined in BS 5724-1 or in BS 6641: SMALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. This public

13、ation does not purport to include all the necessary provisions of a contract. Users are responsible for its 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

14、, the EN title page, pages 2 to 65 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14465 5 August 2003 Revision to 29.3.1.1EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM E

15、N 60601-2-1 August 1998 + A1 June 2002 ICS 11.060.40 Descriptors: Medical electrical equipment, electron accelerators, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical

16、 electrical equipment Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (includes amendment A1:2002) (IEC 60601-2-1:1998 + A1:2002) Appareils lectromdicaux Partie 2-1: Rgles particulires de scurit pour les acclrateurs dlectrons dans la gamme de

17、 1 MeV 5 0 M e V (inclut lamendement A1:2002) (CEI 60601-2-1:1998 + A1:2002) Medizinische elektrische Gerte Teil 2-1: Besondere Festlegungen fr die Sicherheit von Elektronenbeschleuniger im Bereich von 1 MeV bis 50 MeV (enthlt nderung A1:2002) (IEC 60601-2-1:1998 + A1:2002) This European Standard wa

18、s approved by CENELEC on 1998-08-01; amendment A1 was approved by CENELEC on 2002-06-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date

19、 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). A version in any other language made by translation under t

20、he 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irel

21、and, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de St

22、assart 35, B-1050 Brussels 1998 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-1:1998 + A1:2002 EEN 60601-2-1:1998 BSI 5 August 2003 2 Foreword The text of document 62C/232/FDIS, future edition 2 of IEC 60601-2-1, prepared

23、by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-1 on 1998-08-01. The following dates were fixed: Annexes designated “norma

24、tive” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex ZA is normative and Annex AA and Annex BB are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 60601-2-1:

25、1998 was approved by CENELEC as a European Standard without any modification. In the official version, for Annex BB, Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1-1 NOTE Harmonized as EN 60601-1-1:1993 (not modified). IEC 60601-1-3 NOTE Harmonized as EN

26、60601-1-3:1994 (not modified). Foreword to amendment A1 The text of document 62C/329/FDIS, future amendment 1 to IEC 60601-2-1:1998, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the

27、IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 60601-2-1:1998 on 2002-06-01. The following dates were fixed: Endorsement notice The text of amendment 1:2002, to the International Standard IEC 60601-2-1:1998, was approved by CENELEC as an amendment to the European Standar

28、d without any modification. Contents Page Foreword 2 Introduction 5 Section 1. General 1 Scope and object 7 2 Terminology and definitions 9 4 General requirements for tests 11 5 Classification 11 6 Identification, marking and documents 13 Section 2. Environmental conditions 17 10 Environmental condi

29、tions 17 Section 3. Protection against electric shock hazards 19 16 ENCLOSURES and PROTECTIVE COVERS 19 18 Protective earthing, functional earthing and potential equalization 20 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 20 latest date by which the EN has to be implemented at nati

30、onal level by publication of an identical national standard or by endorsement (dop) 1999-05-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2001-05-01 latest date by which the amendment has to be implemented at national level by publication of an ide

31、ntical national standard or by endorsement (dop) 2003-03-01 latest date by which the national standards conflicting with the amendment have to be withdrawn (dow) 2005-06-01EN 60601-2-1:1998 BSI 5 August 2003 3 Page Section 4. Protection against mechanical hazards 21 22 Moving parts 21 27 Pneumatic a

32、nd hydraulic power 23 28 Suspended masses 24 Section 5. Protection against hazards from unwanted or excessive radiation 25 29 X-RADIATION 25 29 IONIZING RADIATION safety requirements 25 29.1 Protection against incorrect ABSORBED DOSE in the TREATMENT VOLUME 25 29.1.1 Monitoring and control of ABSORB

33、ED DOSE 25 29.1.1.1 DOSE MONITORING SYSTEMS 25 29.1.1.2 RADIATION DETECTORS 26 29.1.1.3 Selection and DISPLAY of DOSE MONITOR UNITS 27 29.1.1.4 TERMINATION OF IRRADIATION by the DOSE MONITORING SYSTEM 27 29.1.1.5 Monitoring of distribution of ABSORBED DOSE 28 29.1.2 CONTROLLING TIMER 28 29.1.3 ABSOR

34、BED DOSE RATE 29 29.1.4 Selection and DISPLAY of RADIATION TYPE 30 29.1.5 Selection and DISPLAY of ENERGY 31 29.1.6 Selection and DISPLAY of STATIONARY RADIOTHERAPY and MOVING BEAM RADIOTHERAPY 31 29.1.7 RADIATION BEAM production and distribution systems 32 29.1.7.1 Selection and DISPLAY of TARGETS

35、or other movable RADIATION BEAM production devices 32 29.1.7.2 Selection and DISPLAY of FIELD FLATTENING and BEAM SCATTERING FILTERS 33 29.1.7.3 RADIATION BEAM distribution systems not using FIELD FLATTENING or BEAM SCATTERING FILTERS 33 29.1.8 Selection and DISPLAY of WEDGE FILTERS 35 29.1.9 ELECTR

36、ON BEAM APPLICATORS and trays for RADIATION BEAM modifying devices 36 29.1.10 Control of EQUIPMENT use 36 29.1.11 Starting conditions 37 29.1.12 INTERRUPTION OF IRRADIATION 37 29.1.13 TERMINATION OF IRRADIATION 38 Page 29.1.14 Abnormal TERMINATION OF IRRADIATION 38 29.1.15 PROGRAMMABLE ELECTRONIC SU

37、BSYSTEMS 39 29.2 Protection against STRAY RADIATION in the RADIATION FIELD 39 29.2.1 STRAY X-RADIATION during ELECTRON IRRADIATION 39 29.2.2 RELATIVE SURFACE DOSE during X-IRRADIATION 40 29.2.3 STRAY NEUTRON RADIATION 40 29.3 Protection against RADIATION in the PATIENT plane outside the RADIATION FI

38、ELD 40 29.3.1 LEAKAGE RADIATION through BEAM LIMITING DEVICES 40 29.3.1.1 X-RADIATION 40 29.3.1.2 ELECTRON RADIATION 42 29.3.2 LEAKAGE RADIATION (excluding NEUTRONS) outside the area M 43 29.3.3 LEAKAGE NEUTRON RADIATION outside the area M 44 29.3.4 LEAKAGE RADIATION under fault conditions 44 29.4 R

39、ADIATION safety for PATIENTS and others 44 29.4.1 LEAKAGE X-RADIATION outside the PATIENT plane 44 29.4.2 LEAKAGE NEUTRON RADIATION outside the PATIENT plane 45 29.4.3 Emission of IONIZING RADIATION after TERMINATION OF IRRADIATION due to INDUCED RADIOACTIVITY 45 29.4.4 Retractable RADIATION BEAM sh

40、ield 45 29.4.5 Adventitious IONIZING RADIATION 46 36 ELECTROMAGNETIC COMPATIBILITY 46 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures 47 Section 9. Abnormal operation and fault conditions; Environmental tests 49 52 Abnormal operation and fault conditions 49 Sectio

41、n 10. Constructional requirements 51 57 MAINS PARTS, components and layout 51 Appendix L (normative) References Publications mentioned in this standard 60 Annex AA (informative) Terminology Index of defined terms 61 Annex BB (informative) Bibliography 64EN 60601-2-1:1998 BSI 5 August 2003 4 Page Ann

42、ex ZA (normative) Normative references to international publications with their corresponding European publications 65 Figure 101 Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (29.2.1)5 2 Figure 102 Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (29.2.2)5 3 Figure 103 Elevation view

43、Application of LEAKAGE RADIATION requirements (29.3 and 29.4)5 4 Figure 104 24 measurement points for averaging LEAKAGE RADIATION during X-IRRADIATION (29.3.1.1)5 5 Figure 105 Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during ELECTRON IRRADIATION (29.3.1.2)5 6 Figure 106 Measureme

44、nt points for averaging LEAKAGE RADIATION during ELECTRON IRRADIATION (29.3.1.2)5 7 Figure 107 24 measurement points for averaging LEAKAGE RADIATION outside area M (29.3.2)5 8 Figure 108 EQUIPMENT movements and scales 59 Table 101 Data required in the technical description to support Clause 29 SITE

45、TEST compliance 12 Table 102 Clauses and subclauses in this Particular Standard that require the provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical description 19 Table 103 Limits of STRAY X-RADIATION during ELECTRON IRRADIATION 39 Table 104 Limits of RELA

46、TIVE SURFACE DOSE during X-IRRADIATION 40EN 60601-2-1:1998 BSI 5 August 2003 5 Introduction The use of ELECTRON ACCELERATORS for RADIOTHERAPY purposes may expose PATIENTS to danger if the EQUIPMENT fails to deliver the required dose to the PATIENT, or if the EQUIPMENT design does not satisfy standar

47、ds of electrical and mechanical safety. The EQUIPMENT may also cause danger to persons in the vicinity if the EQUIPMENT itself fails to contain the RADIATION adequately and/or if there are inadequacies in the design of the TREATMENT ROOM. This Particular Standard establishes requirements to be compl

48、ied with by MANUFACTURERS in the design and construction of ELECTRON ACCELERATORS for use in RADIOTHERAPY; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe opera

49、tion of such EQUIPMENT; it places limits on the degradation of EQUIPMENT performance beyond which it can be presumed that a fault condition exists and where an INTERLOCK then operates to prevent continued operation of the EQUIPMENT. Clause 29 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to avoid an unsafe condition. tYPE TESTS that are performed by the MANUFACTURER, and/or SITE TESTS