1、BRITISH STANDARD BS EN 60601-2-17:2004 Medical electrical equipment Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment The European Standard EN 60601-2-17:2004 has the status of a British Standard ICS 11.040.60; 19.100 BS EN 60601-2-17:
2、2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 26 April 2004 BSI 26 April 2004 ISBN 0 580 43666 7 National foreword This British Standard is the official English language version of EN 60601-2-17:2004. It is identical with IEC 60601-2-1
3、7:2004. It supersedes BS EN 60601-2-17:1996 which is withdrawn.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 for radiotherapy, nuclear medicine and radiation dosimetry, which has t
4、he responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section e
5、ntitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compli
6、ance with a British Standard does not of itself confer immunity from legal obligations. 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; monitor related
7、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 page, pages 2 to 32, inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document
8、was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN 60601-2-17 NORME EUROPENNE EUROPISCHE NORM April 2004 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnisc
9、he Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-17:2004 E ICS 11.040.60; 19.100 Supersedes EN 60601-2-17:1996 + A1:1996English version Medical elec
10、trical equipment Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004) Appareils lectromdicaux Partie 2-17: Rgles particulires de scurit des appareils projecteurs de brachythrapie avec contrles automatiques (CEI 60601
11、-2-17:2004) Medizinische elektrische Gerte Teil 2-17: Besondere Festlegungen fr die Sicherheit ferngesteuerter, automatisch betriebener Afterloading-Gerte fr die Brachytherapie (IEC 60601-2-17:2004) This European Standard was approved by CENELEC on 2004-03-01. CENELEC members are bound to comply wit
12、h 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 lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretari
13、at 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 the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the o
14、fficial versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slo
15、venia, Spain, Sweden, Switzerland and United Kingdom. Foreword The text of document 62C/363/FDIS, future edition 2 of IEC 60601-2-17, 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
16、 IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-17 on 2004-03-01. This European Standard supersedes EN 60601-2-17:1996 + A1:1996. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard
17、or by endorsement (dop) 2004-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2007-03-01 In this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: roman type; explanations, advice, not
18、es, general statements, exceptions and references: small roman type; test specifications: italic type; TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH ARE DEFINED IN CLAUSE 2 OR IN THE GENERAL STANDARD EN 60601-1, ITS COLLATERAL OR PART 2 STANDARDS, OR IN IEC 60788: SMALL CAPITALS. Annex ZA has
19、 been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-17:2004 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: IEC 60601-1-3 NOT
20、E Harmonized as EN 60601-1-3:1994 (not modified). _ Page2 EN60601217:2004 CONTENTS INTRODUCTION.4 SECTION ONE GENERAL 1 Scope and object5 2 Terminology and definitions 7 4 General requirements for tests9 5 Classification9 6 Identification, marking and documents 10 SECTION TWO ENVIRONMENTAL CONDITION
21、S 10 Environmental conditions 14 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS. SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 29 X-radiation14 30 Alpha, beta, gamma, NEUTRON RADIATION and other particle radia
22、tion .14 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data24 SECTION NINE
23、 ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions27 SECTION TEN CONSTRUCTIONAL REQUIREMENTS Appendix L (normative) References Publications mentioned in this standard.28 Annex ZA (normative) Normative references to international publications with
24、 their corresponding European publication29 Bibliography30 Index of defined terms.31 Page3 EN60601217:2004 INTRODUCTION The use of AFTERLOADING EQUIPMENT for BRACHYTHERAPY purposes may expose PATIENTS to danger if the EQUIPMENT fails to deliver the required dose to the PATIENT, or if the EQUIPMENT d
25、esign does not satisfy standards of electrical and mechanical safety. The EQUIPMENT may also cause danger to persons in the vicinity if the EQUIPMENT itself fails to contain the RADIOACTIVE SOURCE(S) adequately within the STORAGE CONTAINER(S) and/or if there are inadequacies in the design of the TRE
26、ATMENT ROOM. This Particular Standard establishes requirements to be complied with by MANUFACTURERS in the design and construction of AFTERLOADING EQUIPMENT for use in temporary BRACHY- THERAPY procedures; it does not attempt to define their optimum performance requirements. Its purpose is to identi
27、fy those features of design that are regarded, at the present time, as essential 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 and where an INTERLOCK then operates to return the RAD
28、IOACTIVE SOURCE(S) to the STORAGE CONTAINER(S) and afterwards to prevent continued operation of the EQUIPMENT. Page4 EN60601217:2004 MEDICAL ELECTRICAL EQUIPMENT Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment SECTION ONE GENERAL The
29、 clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: 1.1.101 This Particular Standard specifies requirements for the safety of automatically- controlled EQUIPMENT
30、 for BRACHYTHERAPY of patients using AFTERLOADING techniques. 1.1.102 This Standard specifies requirements for automatically-controlled AFTERLOADING EQUIPMENT which contains and uses only beta, gamma, and NEUTRON-emitting SEALED RADIOACTIVE SOURCES, which automatically drives the sealed radioactive
31、source(s) from a storage container to a treatment position inside the source applicator(s) and returns the source(s) to the storage container, which is designed for connection to a PATIENT, and with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the EQUIPMENT according
32、 to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems. 1.1.103 This Standard specifies requirements for EQUI
33、PMENT intended to be used under the supervision of QUALIFIED PERSONS; maintained at predetermined intervals; subject to regular checks by the user. This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the EQUIPMENT. Such requirements are specified in other standards (
34、see 6.8.3). 1.1.104 The requirements of this Standard are based on the assumptions that: a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS, and the SOURCE STRENGTH(S) of the RADIOACTIVE SOURCE(S) used by the EQUIPMENT is (are) known. Page5 EN60601217:2004 T
35、his Standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that: the selected RADIOACTIVE SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to th
36、e SOURCE APPLICATOR; IRRADIATION is performed by the selected RADIOACTIVE SOURCE configuration for the selected duration; IRRADIATION is performed by the EQUIPMENT without causing unnecessary risk to the OPERATOR or other persons in the immediate surroundings. 1.2 Object Replacement: The object of t
37、his Particular Standard is to establish particular requirements for safety of automatically-controlled BRACHYTHERAPY AFTERLOADING EQUIPMENT and the compliance test specifications. It presents the general functional requirements of the demand for safety rather than particular technological means of i
38、mplementation. 1.3 Particular Standards ADDITION: 1.3.101 Relationship to the General Standard This Particular Standard is to be read in conjunction with IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety, with its Amendments 1 (1991) and 2 (1995) hereinafter refe
39、rred to as the General Standard which it amends and supplements. As in the General Standard, the requirements are followed by compliance tests. The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. The changes to the text of the Ge
40、neral and Collateral Standards are specified by the use of the following words: “Replacement“ means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard; “Addition“ means that the text of this Particular Standard is additional to the req
41、uirements of the General Standard; “Amendment“ means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses, figures or tables which are additional to those of the General Standard are numbered starting from 101: additional an
42、nexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this Standard “ is used to make reference to the General Standard and this Particular Standard taken together. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause
43、or subclause of the General Standard, although possibly not relevant, applies without modification. Where 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. The requirements of this
44、Particular Standard take priority over those of the General Standard. Page6 EN60601217:2004 1.3.102 Relationship to other standards and documents NOTE See Appendix L for normative references. 1.5 Collateral Standards Addition: 1.5.101 IEC 60601-1-1 All clauses and subclauses of Collateral Standard I
45、EC 60601-1-1apply. 1.5.102 IEC 60601-1-2 All clauses and subclauses of Collateral Standard IEC 60601-1-2 apply. 1.5.103 IEC 60601-1-3 Collateral Standard IEC 60601-1-3 does not apply. 1.5.104 IEC 60601-1-4 All clauses and subclauses of Collateral Standard IEC 60601-1-4 apply. 2 Terminology and defin
46、itions This clause of the General Standard applies except as follows: Addition: For the purposes of this document, the terms and definitions given in the General Standard or in its Collateral Standards and the following apply. NOTE 1 The Index of defined terms at the end of this document lists defin
47、ed terms alphabetically with their source reference. NOTE 2 In this Particular Standard, IRRADIATION refers to the entire process of exposing the patient to RADIOACTIVE SOURCES in positions and for periods of time appropriate for TREATMENT. TRANSIT times are explicitly excluded from the TREATMENT TI
48、ME. NOTE 3 Although the actual titles of the persons fulfilling the following roles may vary from country to country, in this Particular Standard the term OPERATOR is used to denote the person controlling the BRACHYTHERAPY EQUIPMENT during treatment, and the term USER to denote the organization or i
49、ndividual responsible for the use and maintenance of the BRACHYTHERAPY AFTERLOADING EQUIPMENT. The terms radiotherapist and radiation oncologist, although not used in this Particular Standard, are used in many countries to denote the person exercising medical supervision and responsibility for determining and prescribing PATIENT treatment. 2.1 EQUIPMENT parts, auxiliaries and ACCESSO
