BS-EN-60976-2007.pdf
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1、BRITISH STANDARD BS EN 60976:2007 Medical electrical equipment Medical electron accelerators Functional performance characteristics ICS 11.040.50; 13.280 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale,
2、 08/14/2008 21:16:56 MDTNo reproduction or networking permitted without license from IHS -,-,- BS EN 60976:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2008 BSI 2008 ISBN 978 0 580 55685 2 National foreword This British Stand
3、ard is the UK implementation of EN 60976:2007. It is identical to IEC 60976:2007. It supersedes BS EN 60976:2001 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/3, Equipment fo
4、r radiotherapy, nuclear medicine and radiation dosimetry. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Com
5、pliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:16
6、:56 MDTNo reproduction or networking permitted without license from IHS -,-,- EUROPEAN STANDARD EN 60976 NORME EUROPENNE EUROPISCHE NORM December 2007 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnis
7、che Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60976:2007 E ICS 11.040.50; 13.280 Supersedes EN 60976:1999 + A1:2000 English version Medical electrical e
8、quipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:2007) Appareils lectromdicaux - Acclrateurs mdicaux dlectrons - Caractristiques fonctionnelles de performance (CEI 60976:2007) Medizinische elektrische Gerte - Medizinische Elektronenbeschleuniger - Apparati
9、ve Qualittsmerkmale (IEC 60976:2007) This European Standard was approved by CENELEC on 2007-11-01. 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.
10、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 translati
11、on 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, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finlan
12、d, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright British Standards Institution Provided by IHS under license with BS
13、I - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:16:56 MDTNo reproduction or networking permitted without license from IHS -,-,- BS EN 60976:2007 2 Foreword The text of document 62C/429/FDIS, future edition 2 of IEC 60976, prepared by SC 62C, Equipment for radiothera
14、py, 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 60976 on 2007-11-01. This European Standard supersedes EN 60976:1999 + A1:2000. EN 60976:2007 includes the addition o
15、f performance standards and test methods relating to the following new technologies: dynamic beam delivery techniques, such as MOVING BEAM RADIOTHERAPY, INTENSITY-MODULATED RADIATION THERAPY (IMRT), IMAGE-GUIDED RADIOTHERAPY (IGRT) and PROGRAMMABLE WEDGE FIELDS (PWF); STEREOTACTIC RADIOTHERAPY (SRT)
16、 / STEREOTACTIC RADIOSURGERY (SRS); use of ELECTRONIC IMAGING DEVICES. This standard, together with IEC/TR 60977, is to be used in conjunction with EN 60601-2-1. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical nationa
17、l standard or by endorsement (dop) 2008-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-11-01 In this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; explanation
18、s, advice, general statements, exceptions and notes: in small roman type; test specifications and headings of sub-clauses: in italic type; TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS
19、. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60976:2007 was approved by CENELEC as a European Standard without any modification. _ Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boei
20、ng Co/5910770001 Not for Resale, 08/14/2008 21:16:56 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 CONTENTS INTRODUCTION?H7 1 Scope .?H8 2 Normative references ?H9 3 Terms and definitions ?H9 4 Environmental conditions.?H13 4.1 General?H13 4.2 Transport and storage ?H13
21、 4.3 Power supply?H13 5 General information to the USER.?H13 5.1 Functional performance characteristics .?H13 5.2 Available nominal energies and ABSORBED DOSE RATES?H14 5.3 Available RADIATION FIELDS?H14 5.4 NORMAL TREATMENT DISTANCE?H14 5.5 Available WEDGE X-RAY FIELDS.?H14 5.6 Available flattening
22、 FILTERS.?H14 5.7 Availability?H15 5.8 Influencing quantities?H15 5.9 Maintenance.?H15 5.10 Presentation.?H15 5.11 Dimensions, clearances, within the RADIATION HEAD, and in the region RADIATION HEAD to ISOCENTRE, of BEAM LIMITING DEVICES.?H15 5.12 IMRT?H15 6 Standardized test conditions?H16 6.1 Gene
23、ral?H16 6.2 Angle settings.?H16 6.3 Properties and positioning of the PHANTOM?H16 6.4 Positioning of measuring points ?H16 6.5 RADIATION DETECTORS.?H16 6.6 STANDARD MEASUREMENT DEPTHS.?H17 6.7 RADIATION FIELDS?H17 6.8 Adjustments during test ?H17 6.9 Use of RADIOGRAPHIC FILM or alternative imaging m
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