BS EN 62274-2005 Medical electrical equipment - Safety of radiotherapy record and verify systems《医疗电气设备 放射疗法记录和检验系统的安全》.pdf

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1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58and verify systemsThe European Standard EN 62274:2005 has the status of a British StandardICS 11.04

2、0.60Medical electrical equipment Safety of radiotherapy record BRITISH STANDARDBS EN 62274:2005BS EN 62274:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 December 2005 BSI 28 December 2005ISBN 0 580 47175 6Cross-referencesThe British

3、Standards 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.

4、This publication 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 pagesThis document comprises a front cover, an inside fr

5、ont cover, the EN title page, pages 2 to 18, 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 publicationAmd. No. Date CommentsA list of organizations represented on this subcommittee can be

6、obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.National forewordThis

7、British Standard is the official English language version of EN 62274:2005. It is identical with IEC 62274:2005.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, nucle

8、ar medicine and radiation dosimetry, which has the responsibility to: aid enquirers to understand the text;EUROPEAN STANDARD EN 62274 NORME EUROPENNE EUROPISCHE NORM June 2005 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches

9、Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 62274:2005 E ICS 11.040.60 English version Medical electrical equipment Safety of

10、 radiotherapy record and verify systems (IEC 62274:2005) Appareils lectromdicaux Scurit des systmes denregistrement et de vrification de radiothrapie (CEI 62274:2005) Medizinische elektrische Gerte Sicherheit von Aufzeichnungs- und Verifikationssystemen fr die Strahlentherapie (IEC 62274:2005) This

11、European Standard was approved by CENELEC on 2005-06-01. 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 lists and bibliographical refer

12、ences 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 the responsibility of a CENELEC m

13、ember 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, Germany, Greece, Hungary, Iceland, Ireland, I

14、taly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Foreword The text of document 62C/381/FDIS, future edition 1 of IEC 62274, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiat

15、ion dosimetry“ des IEC TC 62 “Electrical equipment in medical practice“, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62274 on 2005-06-01. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an iden

16、tical national standard or by endorsement (dop) 2006-03-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2008-06-01 In this standard, the following print types are used: - requirements proper: roman type; - test specifications: italic type; - notes an

17、d explanatory matter: small roman type; - TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 62274:2005 was approved by CENELEC as a Eu

18、ropean Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1-6 NOTE Harmonized as EN 60601-1-6:2004 (not modified). IEC 60601-2-11 NOTE Harmonized as EN 60601-2-11:1997 (not modified). IEC 60601-2-1

19、7 NOTE Harmonized as EN 60601-2-17:2004 (not modified). IEC 62083 NOTE Harmonized as EN 62083:2001 (not modified). _ EN 62274:2005 2 3 CONTENTS 1 Scope and object5 2 Normative references .6 3 Terms and definitions .7 4 General requirements for tests7 5 ACCOMPANYING DOCUMENTS .7 6 Requirements for sa

20、fety8 7 TREATMENT machine set-up verification .11 8 TREATMENT recording and reporting.12 9 Accuracy 12 10 Abnormal operation and fault conditions12 11 Human errors in software design.12 12 Change in software versions.13 13 Human errors in use .13 Annex (normative) Hardware safety 14 Annex ZA (normat

21、ive) Normative references to international publications with their corresponding European publications18 Table 1 Clauses and subclauses in this standard that require the provision of information in the ACCOMPANYING DOCUMENTS and the technical description 8 EN 62274:2005INTRODUCTION4 Bibliography.16

22、4 INTRODUCTION A RADIOTHERAPY RECORD AND VERIFY SYSTEM (RVS) is a PEMS (PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM) or a subsystem that is used to help prevent erroneous set-up of a medical ELECTRON ACCELERATOR, GAMMA BEAM THERAPY EQUIPMENT, or other RADIOTHERAPY TREATMENT machine and to record all TREA

23、TMENT sessions. This is accomplished through verification of the set-up and preventing machine operation if the set-up does not match predetermined settings. Inaccuracies in the data or errors in the record and verify process may represent SAFETY HAZARDS to PATIENTS. This standard defines requiremen

24、ts to be complied with by MANUFACTURERS in the design and construction of an RVS in order to provide protection against the occurrence of such hazards. EN 62274:2005 5 MEDICAL ELECTRICAL EQUIPMENT SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS 1 Scope and object 1.1 Scope This International Standa

25、rd applies to the design and manufacture and some installation aspects of a RECORD AND VERIFY SYSTEM (RVS) for use in RADIOTHERAPY in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the OPERATOR or directly from other

26、devices, b) may control the ability of that equipment to operate; c) records data of all TREATMENT sessions; and d) is intended to be: 1) for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; 2) maintained in accorda

27、nce with the recommendations given in the INSTRUCTIONS FOR USE; and 3) used within the environmental and electrical supply conditions specified in the technical description. This standard does not address dynamic beam deliveries. NOTE This may be addressed in a future version of this standard. It do

28、es, however, address certain specific aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be used. 1.2 Object This standard applies to any RVS and establishes the requirements for features, associated documentation, and testing of t

29、he software. Requirements for SAFETY of hardware are not included in this standard, as these vary with the nature of the hardware (see 1.3.1 and Annex A concerning hardware requirements). An RVS developed by a USER exclusively for the USERS own use is not within the scope of this standard, but it is

30、 highly recommended that the principles of this standard be applied in its creation and use. If this technology is provided to another USER under conditions in which the developers do not directly control its use, and is represented as being suitable for use, then the developers assume the role of M

31、ANUFACTURER and this standard applies. EN 62274:2005 6 1.3 Relationship to other standards 1.3.1 Hardware SAFETY standards Requirements for SAFETY of hardware, such as for protection against electric shock, fire, and for ELECTROMAGNETIC COMPATIBILITY, are not included in this document. SAFETY requir

32、es that these subjects be addressed by the MANUFACTURER separately through compliance with an appropriate standard, depending upon the nature and environment of the hardware used for the RVS (see Annex A for hardware SAFETY standards). 1.3.2 Software SAFETY standards All clauses and subclauses of th

33、e collateral standard IEC 60601-1-4 (see 4.1) apply. In applying IEC 60601-1-4, the MANUFACTURER shall consider hazards that could occur due to use errors associated with the RVS. NOTE IEC 60601-1-6 describes a process for the risk management of use errors. 1.3.3 IEC 61217 IEC 61217, Radiotherapy eq

34、uipment Co-ordinates, movements and scales, applies. The means of applying IEC 61217 are specified in appropriate subclauses of this standard. 1.3.4 Other standards Because an RVS is likely to contain PATIENT-related information and other medical data, standards related to confidentiality of PATIENT

35、 information and security of electronic records may apply. Where there is an apparent conflict between any of these standards and a requirement of this standard, the MANUFACTURER shall resolve the conflict in a way that best meets the intent of each standard, and shall explain the implementation in

36、the ACCOMPANYING DOCUMENTS. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies

37、. IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-4:1996, Medical electrical equipment Part 1-

38、4: General requirements for safety Collateral Standard: Programmable electrical medical systems Amendment 1 (1999)1)IEC 60601-2-29, Medical electrical equipment Part 2-29: Particular requirements for the safety of radiotherapy simulators IEC TR 60788, Medical electrical equipment Glossary of defined

39、 terms _ 1)A consolidated edition 1.1 exists including IEC 60601-1-4:1996 and its Amendment 1 (1999). EN 62274:2005 7 IEC 60950-1, Information technology equipment Safety Part 1: General requirements IEC 61000 (all parts), Electromagnetic compatibility (EMC) IEC 61217, Radiotherapy equipment Co-ordi

40、nates, movements and scales 3 Terms and definitions For the purpose of this document, the terms and definitions given in IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-29 and IEC 60788 and the following apply. 3.1 RECORD AND VERIFY SYSTEM RVS PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM or subsyst

41、em including its associated peripherals, that is used to compare the set-up of a RADIOTHERAPY TREATMENT machine to predetermined set-up conditions prior to the start of a proposed RADIOTHERAPY TREATMENT and each TREATMENT session, and record actual TREATMENT sessions. It also provides a means of pre

42、venting the machine operation if the actual set-up is not the same as the pre-set intended set-up, within USER defined tolerances. 4 General requirements for tests 4.1 Testing during development Compliance with IEC 60601-1-4 requires identification of HAZARDS, assessment of their RISKS, and appropri

43、ate verification and validation of RISK controls. Demonstration of compliance with the requirements of this standard shall be included as part of the above processes, with explicit reference to each requirement. The MANUFACTURER shall retain compliance data as a permanent record. Each test shall inc

44、lude a protocol containing all the necessary input data, sufficient detail to provide for exact reproducibility, and the expected result. 4.2 Testing during installation The MANUFACTURER shall provide an installation test document as part of the technical description that includes a demonstration th

45、at the RVS performs according to the operational description provided in the ACCOMPANYING DOCUMENTS as required in Clause 5. 5 ACCOMPANYING DOCUMENTS The technical description and the INSTRUCTIONS FOR USE shall contain the information as required by this standard (see Table 1 for references). EN 622

46、74:2005 8 Table 1 Clauses and subclauses in this standard that require the provision of information in the ACCOMPANYING DOCUMENTS and the technical description Check reference Instructions for use Technical description 1 6.3 2 6.4 a) 3 6.4 b) 4 6.5 5 6.6 6 6.7 7 6.8 6.9 8 6.9 9 7.2 10 7.3 11 7.4 12

47、9 13 14 10.1 15 10.2 16 11 17 12 a) 18 12 b) 19 20 12 d) 21 13 22 A.1.4 23 A.3 NOTE The check reference is given as an aid for checking the availability of compliance documentation. 6 Requirements for safety 6.1 RADIATION quantities All values of RADIATION quantities requested, displayed or printed

48、shall include their units. Units of RADIATION should conform to the SI convention. Units (e.g. “monitor units” (MU) describing dose delivery shall be consistent with those used by the TREATMENT machine. Compliance is checked by inspection of the DISPLAY and output information. 6.2 Date and time When

49、 the date is displayed or printed, correct interpretation shall not depend upon the OPERATORs interpretation of format, and a DISPLAY of the year shall be in four digits. EN 62274:2005 9 Examples (acceptable): 03 Apr 2005, 03/04/2005 (dd/mm/yyyy), 2005/04/03 (yyyy/mm/dd) Examples (not acceptable): 03/04/05, 03/04/2005, 03 Apr 05. When the time is requested, displayed or printed, it shall be represented on a 24-hour clock