EN 60601-2-11-1997 en Medical Electrical Equipment Part 2 Particular Requirements for the Safety of Gamma Beam Therapy Equipment (Incorporates Amendment A1 2004 Remains Current)《医用.pdf

1、BRITISH STANDARD BS EN 60601-2-11:1998 IEC 60601-2-11: 1997 BS 5724-2.11: 1998 Incorporating Amendment No. 1 Medical electrical equipment Part 2: Particular requirements for safety Section 2.11: Specification for gamma beam therapy equipment The European Standard EN 60601-2-11:1997, with the incorpo

2、ration of amendment A1:2004, has the status of a British Standard ICS 11.040.50; 11.040.60 BS EN 60601-2-11:1998 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

3、on 15 April 1998 BSI 28 October 2004 ISBN 0 580 28450 6 National foreword This British Standard is the official English language version of EN 60601-2-11:1997, including amendment A1:2004. It is identical with IEC 60601-2-11:1997, including amendment 1:2004. It supersedes BS 5724-2.11:1989, BS 5724-

4、2.11:Supplement 1:1989 and BS 5724-2.11:Supplement 2:1993 which are withdrawn. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. Tags indicating changes to CENELEC text carry the number of the CENELEC amendment. For example, text altered by CENELEC

5、amendment A1 is indicated by !“. The UK participation in its preparation was entrusted to Technical Committee CH/81, Radiotherapy equipment, which has the responsibility to: A list of organizations represented on this committee can be obtained to its secretary. Cross-references The British Standards

6、 which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This pub

7、lication 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. aid enquirers to understand the text; present to the responsible internati

8、onal/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title

9、 page, pages 2 to 56, an inside back cover 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 15391 28 October 2004 See national forewordEUROPEAN STANDARD NORME EUROPENNE EUROPI

10、SCHE NORM EN 60601-2-11 September 1997 +A1 September 2004 ICS 11.040.50 Supersedes HD 395.2.11 S2:1990 Descriptors: Medical electrical equipment, gamma radiation equipment, therapy, definitions, safety requirements, protection against electric shock, protection against mechanical hazard, radiation p

11、rotection, fire protection, environmental conditions English version Medical electrical equipment Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (includes amendment A1:2004) (IEC 60601-2-11:1997 + A1:2004) Appareils lectromdicaux Partie 2-11: Rgles particulires de

12、scurit pour les appareils de gammathrapie (inclut lamendement A1:2004) (CEI 60601-2-11:1997 + A1:2004) Medizinische elektrische Gerte Teil 2-11: Besondere Festlegungen fr die Strahlensicherheit von Gamma-Bestrahlungseinrichtungen (enthlt nderung A1:2004) (IEC 60601-2-11:1997 + A1:2004) This European

13、 Standard was approved by CENELEC on 1997-07-01; amendment A1 was approved by CENELEC on 2004-09-01. 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

14、. 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). A version in any other language made by transla

15、tion 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, G

16、ermany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotech

17、nique Europisches Komitee fr Elektrotechnische 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 60601-2-11:1997 + A1:2004 EEN 60601-2-11:1997 BSI 28 October 2004 2

18、 Foreword The text of document 62C/173/FDIS, future edition 2 of IEC 60601-2-11, 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 IEC-CENELEC parallel vote and was approved by CENELE

19、C as EN 60601-2-11 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 ZA is normative and Annex AA is informative. Annex ZA has been added by CENE

20、LEC. Endorsement notice The text of the International Standard IEC 60601-2-11:1997 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1 The text of document 62C/372/FDIS, future amendment 1 to IEC 60601-2-11:1997, prepared by SC 62C, Equipment for radioth

21、erapy, 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 amendment A1 to EN 60601-2-11:1997 on 2004-09-01. The following dates were fixed: Endorsement notice The text of amen

22、dment 1:2004 to the International Standard IEC 60601-2-11:1997 was approved by CENELEC as an amendment to the European Standard without any modification. Contents Page Foreword 2 Introduction 5 Section 1. General 1 Scope and object 7 2 Terminology and definitions 8 4 General requirements for tests 1

23、1 5 Classification 12 6 Identification, marking and documents 13 Section 2. Environmental conditions 10 Environmental conditions 17 Section 3. Protection against electric shock hazards 16 ENCLOSURES and PROTECTIVE COVERS 19 18 Protective earthing, functional earthing and potential equalization 19 19

24、 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 19 20 Dielectric strength 20 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 1998-05-01 latest date by which the national standards conflicting wit

25、h the EN have to be withdrawn (dow) 1998-05-01 latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2005-06-01 latest date by which the national standards conflicting with the amendment have to be withdraw

26、n (dow) 2007-09-01EN 60601-2-11:1997 BSI 28 October 2004 3 Page Section 4. Protection against mechanical hazards 21 Mechanical strength 21 22 Moving parts 21 27 Pneumatic and hydraulic power 22 28 Suspended masses 22 Section 5. Protection against hazards from unwanted or excessive radiation 29 RADIA

27、TION safety requirements 23 29.1 Protection of the PATIENT against incorrect ABSORBED DOSE in the TREATMENT VOLUME 23 29.1.1 SOURCE CARRIER or SHUTTER 23 29.1.2 BEAM OFF and BEAM ON conditions 24 29.1.3 Control of IRRADIATION 25 29.1.4 STATIONARY RADIOTHERAPY and MOVING BEAM RADIOTHERAPY 27 29.1.5 B

28、eam distributing systems 28 29.1.6 WEDGE FILTERS 29 29.1.7 BEAM APPLICATORS 30 29.1.8 Facilities for starting IRRADIATION 30 29.1.9 Facilities for INTERRUPTION OF IRRADIATION 30 29.1.10 Facilities for TERMINATION OF IRRADIATION 30 29.1.11 Unplanned TERMINATION OF IRRADIATION 31 29.1.12 Facilities fo

29、r checking INTERLOCK systems 31 29.2 Protection of the PATIENT against STRAY RADIATION in the RADIATION BEAM 32 29.2.1 RELATIVE SURFACE DOSE 32 29.3 Protection of the PATIENT against RADIATION outside the RADIATION BEAM 32 29.3.1 LEAKAGE RADIATION through BEAM LIMITING DEVICES during IRRADIATION 32

30、29.3.2 LEAKAGE RADIATION outside the maximum RADIATION BEAM 33 29.4 RADIATION safety for persons other than PATIENTS 35 29.4.1 Indication of BEAM OFF and BEAM ON conditions 35 29.4.2 STRAY RADIATION in the BEAM OFF condition 35 29.4.3 Safety in setting operating states 36 29.4.4 RADIATION SOURCE and

31、 RADIATION HEAD 36 Page 29.4.5 Radioactive materials used in the construction of the EQUIPMENT 37 29.4.6 Environmental protection 37 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures 39 Section 7. Protection against excessive temperatures and other safety hazards 41

32、 Section 8. Accuracy of operating data and protection against hazardous output 43 Section 9. Abnormal operation and fault conditions; environmental tests 45 Section 10. Constructional requirements 57 MAINS PARTS, components and layout 47 Appendix L References Publications mentioned in this standard

33、52 Annex AA (informative) Index of terms 53 Annex ZA (normative) Normative references to international publications with their corresponding European publications 56 Figure 101 LEAKAGE RADIATION 47 Figure 102 The 16 measurement points of the average LEAKAGE RADIATION 48 Figure 103 Test plane orthogo

34、nal to the RADIATION BEAM AXIS at the NORMAL TREATMENT DISTANCE 49 Figure 104 Location of test points for SITE TEST of item a) 2) of 29.3.2 50 Figure 105 Matrix measurement points for BEAM OFF and BEAM ON conditions to be specified at the floor level, 0,5 m, 1,0 m, 1,5 m and 2 m above the floor 514

35、blankEN 60601-2-11:1997 BSI 28 October 2004 5 Introduction The use of GAMMA BEAM THERAPY EQUIPMENT 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 standards of electrical and mecha

36、nical 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 complied with by MANUFACTURERS

37、in the design and construction of GAMMA BEAM THERAPY EQUIPMENT. Clause 29 states tolerance limits beyond which INTERLOCKS must prevent, INTERRUPT or TERMINATE IRRADIATION in order to avoid an unsafe condition. TYPE TESTS which are performed by the MANUFACTURER, and/or SITE TESTS, which are not neces

38、sarily performed by the MANUFACTURER, are specified for each requirement. Clause 29 does not attempt to define the optimum performance requirements for a GAMMA BEAM THERAPY EQUIPMENT for use in RADIOTHERAPY. Its purpose is to identify those features of design which are regarded at the present time a

39、s essential for the safe operation of such EQUIPMENT. It places limits on the degradation of EQUIPMENT performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an INTERLOCK then operates to prevent continued operation of the EQUIPMENT. It should be

40、understood that, before installation, a MANUFACTURER can provide a compliance certificate relating only to TYPE TESTS. Data available from SITE TESTS should be incorporated in the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the EQUIPMENT after installation. The relat

41、ionship of this Particular Standard with IEC 60601-1 (including the amendments) and the Collateral Standards is explained in 1.3.6 blankEN 60601-2-11:1997 BSI 28 October 2004 7 Section 1. General The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and

42、object This clause of the General Standard applies except as follows: 1.1 Scope Addition: aa) This Particular Standard specifies requirements for the safety of GAMMA BEAM THERAPY EQUIPMENT intended for RADIOTHERAPY in human medical practice and includes EQUIPMENT in which the selection and DISPLAY o

43、f operating parameters can be controlled by a PROGRAMMABLE ELECTRONIC SYSTEM (PES). bb) This Particular Standard applies to EQUIPMENT which is intended to deliver a GAMMA RADIATION BEAM(S) at NORMAL TREATMENT DISTANCES greater than 5 cm using a SEALED RADIOACTIVE SOURCE(S). For EQUIPMENT operating a

44、t shorter distances, special precautions may be necessary. !This standard applied also to multi-source STEREOTATIC RADIOTHERAPY equipment used to IRRADIATE a single ISOCENTRE simultaneously with more than one SEALED RADIOACTIVE SOURCE. The sources may be stationary or moving. “ cc) This Particular S

45、tandard applies to EQUIPMENT intended to be: used under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the skills required for a particular medical application and acting in accordance with the INSTRUCTIONS FOR USE; maintained at predetermined intervals; subject to

46、 regular checks by the USER; used for particular specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY. dd) This Particular Standard is applicable to the manufacture and some installation aspects of GAMMA BEAM THERAPY EQUIPMENT by the inclusion of TYPE TESTS and SITE

47、TESTS respectively. ee) This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the requirements for the RADIATION SOURCES. 1.2 Object Addition: aa) This Particular Standard establishes requirements to ensure the RADIATION safety and enhance the electrical and mechanic

48、al safety of GAMMA BEAM THERAPY EQUIPMENT used in human medical practice and specifies tests for demonstrating compliance with those requirements. bb) In EQUIPMENT of the type covered by this Standard, ABSORBED DOSE 1)is controlled by the time of IRRADIATION. Tolerances for other methods of controll

49、ing the ABSORBED DOSE are not included in this Standard. 1) In this Particular Standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water at the depth of maximum BUILD UP.EN 60601-2-11:1997 8 BSI 28 October 2004 1.3 Particular Standards Addition: This Particular Standard amends and supplements IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety and amendments 1 (1991) and 2 (1995). IEC 60601-1 is