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1、BRITISH STANDARD BS EN 60601-2-29:1999 IEC 60601-2-29:1999 BS 5724-2-129:1999 Medical electrical equipment Part 2-29: Particular requirements for the safety of radiotherapy simulators The European Standard EN 60601-2-29:1999 has the status of a British Standard ICS 11.040.50 Licensed Copy: sheffield
2、un sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-29:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect
3、on 15 June 1999 BSI 03-2000 ISBN 0 580 32552 0 Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-29:1999 BSI 03-2000i Contents Page National forewordii Foreword2 Text of EN
4、 60601-2-293 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-29:1999 ii BSI 03-2000 National foreword This British Standard is the English language version of EN 60601-2-29:1999. It is identical with IEC 60601-2-29:1999. It sup
5、ersedes BS EN 60601-2-29:1996 and its amendment A1:1997, which are withdrawn. This particular standard amends and supplements BS EN 60601-1, hereinafter called the general standard. As stated in 1.3 of the general standard, the requirements of this particular standard take precedence over those of t
6、he general standard. As in the general standard, the requirements are followed by compliance tests. The numbers of the section and clauses in this standard refer to the related sections and clauses in the general standard. Clauses, subclauses or figures that are additional to those of the general st
7、andard are numbered starting from 101; additional appendices 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 specified paragraph of the ge
8、neral 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. “Additional” means that the text of this standard is additional to the requirement of the general
9、 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 interpretation, or proposals
10、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 have the number 60000 ad
11、ded 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 CEN and CENELEC Standards
12、 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 section entitled “Interna
13、tional 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. Explanations, advice, gen
14、eral statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defined in clause 2 of the general standard, or in BS 6641: SMALL CAPITALS. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2
15、-29:1999 BSI 03-2000iii 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 from legal obligations. Summary of pages
16、This document comprises a front cover, an inside front cover, pages i to iv, the EN title page, pages 2 to 24 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 the inside front cover. Licen
17、sed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-29 April 1999 ICS 11.
18、040.60Supersedes EN 60601-2-29:1995 + A1:1996 English version Medical electrical equipment Part 2-29: Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1999) Appareils lectromdicaux Partie 2-29: Rgles particulires de scurit pour les simulateurs de radiothrapie (CEI 60
19、601-2-29:1999) Medizinische elektrische Gerte Teil 2-29: Besondere Festlegungen fr die Sicherheit von Strahlentherapiesimulatoren (IEC 60601-2-29:1999) This European Standard was approved by CENELEC on 1999-04-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which st
20、ipulate the conditions for giving this European Standard the status 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 Stan
21、dard exists in three official versions (English, French, German). 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 natio
22、nal electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Eur
23、open de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1999 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-29:1999 E Licensed Copy: s
24、heffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-29:1999 BSI 03-2000 2 Foreword The text of document 62C/250/FDIS, future edition 2 of IEC 60601-2-29, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC
25、 TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-29 on 1999-04-01. This European Standard supersedes EN 60601-2-29:1995 and its amendment A1:1996. The following dates were fixed: Annexes designated “normative”
26、are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex AA and Annex ZA are normative and Annex BB and Annex ZB are informative. Annex ZA and Annex ZB have been added by CENELEC. Endorsement notice The text of the International S
27、tandard IEC 60601-2-29:1999 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword2 Introduction3 Section 1. General 1Scope and object3 2Terminology and definitions4 5Classification5 6Identification, marking and documents5 Section 2. Environmental conditions
28、10Environmental conditions7 Section 3. Protection against electric shock hazards 16ENCLOSURES and PROTECTIVE COVERS8 Page 18Protective earthing, functional earthing and potential equalization8 19Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS8 Section 4. Protection against mechanical haza
29、rds 22Moving parts9 27Pneumatic and hydraulic power11 28Suspended masses11 Section 5. Protection against hazards from unwanted or excessive radiation 29X-RADIATION generated by SIMULATORS11 36ELECTROMAGNETIC COMPATIBILITY13 Section 6. Protection against hazards of ignition of flammable anaesthetic m
30、ixtures Section 9. Abnormal operation and fault conditions; environmental tests 52Abnormal operation and fault conditions14 Appendix L (normative) References Publications mentioned in this standard19 Annex AA (normative) Terminology Index of defined terms20 Annex BB (informative) Bibliography23 Anne
31、x ZA (normative) Normative references to international publications with their corresponding European publications24 Annex ZB (informative) Other international publications mentioned in this standard with the references of the relevant European publication24 Figure 101 EQUIPMENT movements and scales
32、 Rotary GANTRY (adapted from IEC 60601-2-1) with identification of axes 1 to 8, directions 9 to 13, and dimensions 14 and 1515 Figure 102 EQUIPMENT movements and scales ISOCENTRIC RADIOTHERAPY SIMULATOR or TELERADIOTHERAPY EQUIPMENT, with identification of axes 1; 4 to 6; 19, of directions 9 to 12;
33、16 to 18 and of dimensions 14; 1516 Figure 103 EQUIPMENT movements and scales View from RADIATION SOURCE of TELERADIOTHERAPY RADIATION FIELD or RADIOTHERAPY SIMULATOR DELINEATED RADIATION FIELD17 Table 101 Clauses and subclauses in this Particular Standard that require the provision of information i
34、n the ACCOMPANYING DOCUMENTS, the INSTRUCTIONS FOR USE, and in the technical description7 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2000-01-01 latest date by which the national standards conflicting wi
35、th the EN have to be withdrawn(dow) 2002-04-01 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-29:1999 BSI 03-20003 Introduction The use of RADIOTHERAPY SIMULATORS may expose PATIENTS to danger if the EQUIPMENT design does not sat
36、isfy standards of electrical, mechanical and IONIZING RADIATION safety. The EQUIPMENT may also cause danger to persons in the vicinity if the EQUIPMENT itself fails to contain the IONIZING RADIATION adequately and/or if there are inadequacies in the design of the SIMULATOR room. This Particular Stan
37、dard establishes requirements to be complied with by MANUFACTURERS in the design and construction of RADIOTHERAPY SIMULATORS; 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
38、 for the safe operation of such EQUIPMENT; it places limits on the degradation of EQUIPMENT performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an INTERLOCK then operates to prevent continued operation of the EQUIPMENT. Section 1. Gen
39、eral The clauses and subclauses of this section of the General Standard apply, except as follows: 1 Scope and object 1.1 Scope Addition: This Particular Standard applies to RADIOTHERAPY SIMULATORS: that use diagnostic X-RAY EQUIPMENT to simulate physically a RADIOTHERAPY RADIATION BEAM, so that the
40、TREATMENT VOLUME to be subjected to IRRADIATION during RADIOTHERAPY can be localized, and the position and size of the RADIOTHERAPY RADIATION FIELD can be confirmed; intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general
41、diagnostic examinations; used within the environmental and electrical supply conditions SPECIFIED in the technical description; comprising the following parts: a system for producing an X-RAY BEAM, which simulates the geometry of the RADIOTHERAPY RADIATION BEAM; a system for producing images of the
42、transmitted X-RAY BEAM, for example, either by RADIOGRAPHY or RADIOSCOPY; an assembly to control the size and position of the RADIATION BEAM and to delineate the intended treatment area; a mechanical structure that physically simulates the geometry and movements of the RADIOTHERAPY EQUIPMENT and sup
43、ports the imaging system; a PATIENT SUPPORT system. 1.2 Object Addition: This Particular Standard establishes requirements to ensure the IONIZING RADIATION safety and enhanced mechanical and electrical safety of RADIOTHERAPY SIMULATORS; it identifies geometrical parameters that are critical for the
44、accurate simulation of a RADIOTHERAPY treatment. 1.3 Particular Standards Additional subclauses: 1.3.101 Relationship to the General Standard NOTESee Appendix L for normative references. The requirements of this Particular Standard take priority over those of all other standards; it is to be read in
45、 conjunction with IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety, its amendments 1 (1991) and 2 (1995), and corrigendum (1995) hereinafter referred to as the General Standard which it amends and supplements. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
46、08 02:59:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-29:1999 4 BSI 03-2000 Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification. Wh
47、ere it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. Unless otherwise stated, all clauses of the General Standard apply. As in the General Standard, the requirements are followed b
48、y compliance tests. The term “this standard” is used throughout to refer to the General Standard and this Particular Standard taken together. The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard but see 29.1 b). The changes to the
49、text of the General Standard, or its Collateral Standards, are SPECIFIED by the use of the following words: “Replacement” means that the clause or subclause of the General/Collateral Standard is replaced completely by the text of this Particular Standard. “Addition” means that the text of this Particular Standard is additional to the requirements of the General/Collateral Standard. “Amendment” means that the clause or subclause of the General/Collateral Standard is amended as indicated by the text of this