BS EN 60601-2-9-1997 Medical electrical equipment Particular requirements for safety Specification for patient contact dosemeters used in radiotherapy with electrically connected r.pdf

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1、BRITISH STANDARD BS EN 60601-2-9:1997 BS 5724-2.9: 1997 IEC 601-2-9: 1996 Medical electrical equipment Part 2: Particular requirements for safety Section 2.9 Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors The European Standard EN6060

2、1-2-9:1996, including Corrigendum December1996, has the status of a British Standard ICS 11.040.50; 17.240BSEN60601-2-9:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, was published under the authority ofthe Standards Board and comesint

3、o effect on 15June1997 BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference: CH/83 Draft for comment: 95/561704 DC ISBN 0 580 27645 7 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Comm

4、ittee CH/83, Dosemeters (Medical), upon which the following bodies were represented: British Measurement and Testing Association College of Radiographers Department of Health Institute of Physics and Engineering in Medicine and Biology National Physical Laboratory Royal College of Radiologists Amend

5、ments issued since publication Amd. No. Date CommentsBSEN60601-2-9:1997 BSI 09-1999 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN 60601-2-9 3 List of references Inside back coverBSEN60601-2-9:1997 ii BSI 09-1999 National foreword This British St

6、andard has been prepared by Technical Committee CH/83. It is the English language version of EN60601-2-9:1996 Medical electrical equipment Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors, including Corr

7、igendum December1996, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC601-2-9:1996 published by the International Electrotechnical Commission (IEC). It supersedes BS5724-2.9:1988 which is withdrawn. Additional information. The following pri

8、nt types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defined in clause2 of this standard or in BS6641: SM

9、ALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. 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 w

10、ith a British Standard does not of itself confer immunity from legal obligations. Cross-references Publication referred to Corresponding British Standard IEC 601-1:1998 BS 5724-1:1989 General requirements for safety IEC 601-1:1988 Amendment 1:1991 Amendment 2 to BS 5724-1:1989 General requirements f

11、or safety IEC 601-1:1988 Amendment 2:1995 Amendment 3 to BS 5724-1:1989 General requirements for safety (To be published) IEC 601-1-1:1992 BS EN 60601-1-1:1993 Collateral standard. Safety requirements for medical electrical systems IEC 601-1-2:1993 BS EN 60601-1-2:1993 Collateral standard. Electroma

12、gnetic compatibility. Requirements and tests IEC 788:1984 BS 6641:1985 Glossary of medical radiology terms Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages 2 to 10, an inside back cover and a back cover. This standard has been upd

13、ated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-9 December 1996 ICS 11.040.50; 17.240 Incorporates Corrigendum December 1996 Descriptors: Medical e

14、lectrical equipment, radiotherapy, dosemeters with electrically connected radiation detectors, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Pa

15、rt 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors (IEC 601-2-9:1996) Appareils lectromdicaux Partie 2: Rgles particulires de scurit des dosimtres au contact du patient utiliss en radiothrapie avec des dtect

16、eurs de rayonnement relis lectriquement (CEI 601-2-9:1996) Medizinische elektrische Gerte Teil 2: Besondere Festlegungen fr die Sicherheit von Dosimetern mit Patientenkontakt, die in der Strahlentherapie mit elektrisch verbundenen Strahlungsdetektoren verwendet werden (IEC 601-2-9:1996) This Europea

17、n Standard was approved by CENELEC on1996-10-01. 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 references co

18、ncerning 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 member in

19、to 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, S

20、pain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1996 Copyright reserved to CENELEC m

21、embers Ref. No. EN 60601-2-9:1996 EEN60601-2-9:1996 2 BSI 09-1999 Foreword The text of document62C/158/FDIS, future edition2 of IEC601-2-9, prepared by SC62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC62, Electrical equipment in medical practice, was submitted to

22、 the IEC-CENELEC parallel vote and was approved by CENELEC as EN60601-2-9 on1996-10-01. This European Standard supersedes HD395.2.9 S1:1989. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information

23、 only. In this standard, Annex ZA is normative and Annex AA andAnnex ZB are informative. Annex ZA andAnnex ZB have been added by CENELEC. Endorsement notice The text of the International Standard IEC601-2-9:1996 was approved by CENELEC as a European Standard without any modification. Contents Page F

24、oreword 2 Introduction 3 Section 1. General 1 Scope and object 3 2 Terminology and definitions 4 5 Classification 4 6 Identification, marking and documents 5 Section 2. Environmental conditions Section 3. Protection against electric shock hazards 15 Limitation of voltage and/or energy 5 Section 4. P

25、rotection against mechanical hazards 21 Mechanical strength 5 Section 5. Protection against hazards from unwanted or excessive radiation Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures Section 7. Protection against excessive temperatures and other safety hazards 4

26、4 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 6 Section 8. Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data 6 Section 9. Abnormal operation and fault conditions; environmental tests Section 10. Co

27、nstructional requirements Appendix L References Publications mentioned in this Standard 7 Annex AA (informative) Index of defined terms 8 Annex ZA (normative) Normative references to international publications with their corresponding European publications 10 Annex ZB (informative) Normative referen

28、ces to international publications with their corresponding European publications 10 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 1997-07-01 latest date by which the national standards conflicting with the

29、 EN have to be withdrawn (dow) 1998-06-13EN60601-2-9:1996 BSI 09-1999 3 Introduction The use of DOSEMETERS in RADIOTHERAPY with electrically connected RADIATION DETECTORS may expose PATIENTS to danger if the RADIATION DETECTOR is in physical contact with a PATIENT and the DOSEMETER design does not s

30、atisfy standards of electrical and mechanical safety. a) Most DOSEMETERS for RADIOTHERAPY are not intended for use in contact with a PATIENT: these should conform with the normal safety requirements for electronic measuring apparatus in IEC1010-1. b) If the DETECTOR ASSEMBLY of a DOSEMETER is intend

31、ed for use in contact with a PATIENT during RADIOTHERAPY, the more stringent requirements of this Particular Standard as regards electrical safety, robustness and disinfectability will be applied. c) The MEASURING ASSEMBLY is designed to meet the requirements of IEC601-1 for allowable PATIENT LEAKAG

32、E CURRENTS because it is electrically connected to the RADIATION DETECTOR. d) If DETECTOR ASSEMBLIES and MEASURING ASSEMBLIES are sold separately, or can be disconnected from each other, the USER needs to be told which particular DETECTOR ASSEMBLY/MEASURING ASSEMBLY combinations meet the requirement

33、s of this Particular Standard for use in contact with a PATIENT. It is possible, for example, that a DETECTOR ASSEMBLY connected to an unsuitable MEASURING ASSEMBLY (even if they each met all requirements when connected to suitable partners) could unintentionally have its ACCESSIBLE CONDUCTIVE PARTS

34、 connected to the polarizing supply; such a combination would be unsafe because of the high probability of grounding of the polarizing supply through the PATIENT and, consequently, incorrect readings. This Particular Standard establishes requirements to be complied with by MANUFACTURERS in the desig

35、n and construction of RADIOTHERAPY DOSEMETERS intended for use in physical contact with a PATIENT. Section 1. General The 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 Scop

36、e Addition: This Particular Standard specifies the particular requirements for the safety of DOSEMETERS used in medical practice in the PATIENT ENVIRONMENT for RADIOTHERAPY as defined in2.104. NOTEDOSEMETERS not intended for use in the PATIENT ENVIRONMENT are not covered by this Standard and should

37、meet the requirements of IEC1010-1. The requirements of this Standard for electrical safety, robustness and disinfectability apply to DOSEMETERS with any type of electrically connected RADIATION DETECTOR intended for use in physical contact (not electrical contact) with a PATIENT. The requirements f

38、or performance in IEC731 apply only to DOSEMETERS with IONIZATION CHAMBERS as RADIATION DETECTORS. The DOSE MONITORING SYSTEMS incorporated in RADIOTHERAPY EQUIPMENT are not covered by this Particular Standard. 1.3 Particular Standards Addition: This Particular Standard is to be read in conjunction

39、with IEC601-1 (1988): Medical electrical equipment Part 1: General requirement for safety, with amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this Particular Standard either as the “General Standard” or as the “General Requirements”. A requirement of this Particular Standard

40、 replacing or modifying a requirement of the General Standard takes precedence over the corresponding General Requirement(s). 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 General Standard are

41、 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 requirements of the General Standard.

42、EN60601-2-9:1996 4 BSI 09-1999 “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from101, additional annexes are let

43、tered 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 or subclause o

44、f 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. 1.5 Collateral Standards Replacement: T

45、his Standard is to be read in conjunction with the Collateral Standards IEC601-1-1 and IEC 601-1-2. No other Collateral Standards apply. 2 Terminology and definitions This clause of the General Standard applies except as follows: 2.1.5 APPLIED PART Replacement: A part of a DOSEMETER, the RADIATION D

46、ETECTOR (for example CHAMBER ASSEMBLY) together with any additional protective cover provided by the MANUFACTURER, intended for physical contact (not electrical contact) with the PATIENT (for example for intracavitary use). Additional definitions: 2.101 MEASURING ASSEMBLY a device to convert the out

47、put from the RADIATION DETECTOR into a form suitable for DISPLAY, control or storage of the values of ABSORBED DOSE, ABSORBED DOSE RATE or any dose-related quantities. It includes all electrical circuits in use during the period of patient contact up to and including any SEPARATION DEVICE(S) 2.102 D

48、ETECTOR ASSEMBLY the RADIATION DETECTOR and all other parts to which the RADIATION DETECTOR is permanently attached, except the MEASURING ASSEMBLY 2.103 RADIATION DETECTOR for this standard this is defined as the electrically operated element which directly transduces ABSORBED DOSE, ABSORBED DOSE RA

49、TE or any other dose related quantity, into a measurable electrical signal 2.104 (PATIENT CONTACT) DOSEMETER RADIATION METER used for the measurement on or in the PATIENT of ABSORBED DOSE, ABSORBED DOSE RATE, or any dose-related quantities in IONISING RADIATION, such as EXPOSURE or KERMA. This EQUIPMENT usually consists of one or more RADIATION DETECTOR ASSEMBLIES (for example CHAMBER ASSEMBLIES) and a MEASURING ASSEMBLY 2.105 ACCESSIBLE CONDUCTIVE PARTS conducting parts of EQUIPMENT which can be touched without the use of a tool 2.106 DISINFECTAB