1、STD.BS1 BS EN bDLOL-Z-7-ENGL 1997 lb24Lb7 Cb2047L LT5 BRITISH STANDARD Medical electrical equipment Part 2. Particular requirements for safety Section 2.9 Specification for patient contact doserneters used in radiotherapy with electrically connected radiation detectors The European Stanhd EN 60601-2
2、-9 : 1996, including Corrigendum December 1996, has the status of a British Standard ICs 11.040.50; 17.240 NO COPYING WITHOUT RSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW _ - i_li-z-=- - - -_ BS EN BS 5724 : Section 2.9 : 1997 1996 60601-2-9 : 1997 IEC 601-2-9 : BS EN 60601-2-9 : 1997 been pr
3、epared under the direction of the Health and Amd. No. Date Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 June 1997 O BSI 1997 The foiiowing BSI references relate to the work on this standaxd Committee reference: CW3 Draft for comment:
4、95/561704 DC ISBN O 580 27646 7 Committees responsible for this British Standard Text affected The preparation of this British Standard was entrusted to Technical Committee CW83, Dosemeters (Medid), upon which the following bodies were represented: British Measurement and Testing Association College
5、 of Radiographers Department of Health institute of Physics and Engineering in Medicine and Biology National Physical Labomtory Royal College of Radiologists - - STD-BSI BS EN bObL-i?-q-ENGL 1197 lbZqbb7 S520473 T78 lls BS EN 60601-2-9 : 1997 National foreword This British Standard has been prepared
6、 by Technid Conunittee CW83. It is the English language version of EN 60601-2-9 : 1996 Medica.! 17.240 incorporates Corrigendum December 1996 Descriptors: Medicd electrical equipmcmt radiotherapy, dwemetsn with electricafly connected radiation detecton, safety requirements, protection against decMc
7、shock, protection against mchanicd hazard. radiation protection, fire protection, environmental conditions English version Medical electrcal equipment Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors. (I
8、EC 601-2-9:1996) Appareils lectromdicaux Medizinische elektrische Gerte Partie 2: Rgles particulires de scurit des dosimtres au contact du patient utiliss en radiothrapie avec des dtecteurs de rayonnement relis lectriquement verbundenen Strahlungsdetektoren (CE1 601 -2-9: 1996) Tell 2: Besondere Fes
9、tlegungen fr die Sicherheit von Dosimetern mit Patientenkontakt, die in der Strahlentherapie mit elektrisch verwendet werden (IEC 601 -2-9996) This European Standard was approved by CENELEC on 1996-1 0-01. CENELEC members are bound to comply with the CENICENELEC Internal Regulations which stipulate
10、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 Standard exi
11、sts in three official versions (English, French, German). Aversion in any other language made by translation under the responsibility of a CENELEC member into its own lanuuage and notified to the Centrai Secretariat has the same status as the official versions. CENELEC members are the national elecu
12、otechnical committees of Austria, Belgium, 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 Europen de Normalisation Elec
13、ttotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels * 1996 CopYnQht reserved to CENELEC members Ref. No. EN 60601-2-9:1996 E _ STD-BSI BS EN bDbOl-2-9-ENGL 1777 Lb24bb9 Ob20t75 q0 U Page 2 I EN 60601-2-9 : 1996 Foreword The text of
14、 document 62C/158/fDlS, future edition 2 of IEC 601 -2-9, 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 IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-9 on 19
15、96-10-01. This European Standard supersedes HD 395.2.9 S1:1989. 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 or by endorsement (dop) 1997-07-01 - latest date by which the national standards conf
16、licting with the EN have to be withdrawn (daw) 1998-06-1 3 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annex ZA is normative and annexes AA and ZB are informative. Annexes ZA and ZB have been
17、added by CENELEC. Endorsement notice The text of the International Standard IEC 601 -2-9: 1996 was approved by CENELEC as a European Standard without any modification. - STD-BSI BS EN bObOL-2-1-ENGL 1997 LbZibbS Ob20V7b 787 E Page 3 EN 60601-2-9 : 1996 CONTENTS Page INTRODUCTION . 4 Clause SECTION O
18、NE - GENERAL 1 2 5 6 Scope and object. . 5 Terminology and definitions . 6 Classification . :. .: 7 Identification, marking and documents . 7 . SECTION TWO - ENVIRONMENTAL CONDITIONS SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 15 Limitation of voltage andlor energy . : 8 SECTION FOUR -
19、 PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength i . 8 OR EXCESSIVE RADIATION SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED . SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OT
20、HER SAFETY HAZARDS 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection . 9 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data 1 O SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; E
21、NVIRONMENTAL TESTS SECTION TEN - CONSTRUCTIONAL REQUIREMENTS Appendix L References - Publications mentioned in this Standard . : . 11 Annex AA Index of defined terms . 12 Annex ZA (normative) Normative references to international publications with their corresponding European publications 14 Annex Z
22、B (informative) Normative references to international publications with their corresponding European publications 9 5 STD-BSI BS EN bbOL-2-7-ENGL 1977 Lb24b54 OL2OLi77 bL3 E Page 4 EN 60601-2-9 1996 INTRODUCTION The Use Of DOSEMETERS in RADIOTHERAPY with electrically connected RADIATION DETECTORS ma
23、y expose PATIENTS to danger if the RADIATION DETECTOR is in physical Contact with a PATIENT and the DOSEMETER design does not satisfy 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 n
24、ormal safety requirements for electronic measuring apparatus in IEC 1010-1. 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 o
25、f IEC 601-1 for b) If the DETECTOR ASSEMBLY Of a DOSEMETER is intended for use in Contact with a PATIENT allowable PATIENT LEAKAGE CURRENTS because it is electrically connected to the RADIATION DETECTOR. d) If DETECTOR ASSEMBLIES and MEASURING ASSEMBLIES are sold Separately, or can be disconnected f
26、rom each other, the USER needs to be told which particular DETECTOR ASSEMBLY/MEASURING ASSEMBLY combinations meet the requirements 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
27、if they each met all requirements when connected to suitable partners) could unintentionally have its ACCESSIBLE CONDUCTIVE PARTS 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, cons
28、equently, incorrect readings. This Particular Standard establishes requirements to be complied with by MANUFACTURERS in the design and construction of RADIOTHERAPY DOSEMETERS intended for use in physical contact with a PATIENT. Page 6 EN 60601-2-9 : 1996 MEDICAL ELECTRICAL EQUIPMENT - Part 2: Partic
29、ular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors SECTION ONE - GENERAL The clauses and subciauses of this section of the General Standard apply except as follows: I Scope and object This clause of the General Standard
30、 applies except as follows: 1.1 Scope 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 in 2.104. NOTE - DOSEMETERS not intended for use in the PATIENT ENVIRONMENT are
31、not covered by this Standard and - E = should meet the requirements of IEC 1010-1. The requirements of this Standard for electrical safety, robustness and disinfectability apply to physical contact (not electrical contact) with a PATIENT. The requirements for performance in IEC 731 apply only to DOS
32、EMETERS with IONIZATION CHAMBERS as RADIATION DETECTORS. DOSEMETERS With any type Of eleCtriCally connected RADIATION DETECTOR intended for use in - - - e v1 * * The DOSE MONITORING SYSTEMS incorporated in RADIOTHERAPY EQUIPMENT are not covered by this Particular Standard, I -3 Particular Standards
33、Addition: This Particular Standard is to be read in conjunction with IEC 601-1 (1988): Medical electrical equipment - Part I: 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 th
34、e “General Requirements“. A requirement of this Particular Standard replacing or modifying a requirement of the General Standard takes precedence over the corresponding General Requirement(s). STD-BSI BS EN bObOL-2-9-ENGL 1997 I% Lb2Libbl 0b20Li79 496 = Page 6 EN 60601-2-9 : 1996 The numbering of se
35、ctions, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: “Replacement“ means that the clause or subclause of the General Standard is replaced completely by
36、the text of this Particular Standard. “Addition“ means that the text of this Particular Standard is additional to the requirements 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. Subclaus
37、es or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes 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
38、. 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; where it is intended that any part of the General Standard, although possibly relevant,
39、is not to be applied, a statement to that effect is given in this Particular Standard. 1.5 Collateral Standards Replacement: This Standard is to be read in conjunction with the Collateral Standards IEC 601-1-9 and IEC 601-1-2. No other Collateral Standards apply. 2 Terminology and definitions This c
40、lause of the General Standard applies except as follows: 2.1.5 APPLIED FART Replacement: A part Of a DOSEMETER, the RADIATION DETECTOR (for example CHAMBER ASSEMBLY) together with any additional protective cover provided by the MANUFACTURER, intended for physical contact (not electrical contact) wit
41、h the PATIENT (for example for intracavitary use). Additional definitions: 2.101 MEASURING ASSEMBLY: A device to ConVert the Output from the RADIATION DETECTOR nt0 a form suitable for DISPLAY, Control Or Storage Of the Values Of ABSORBED DOSE, ABSORBED DOSE RATE or any dose-related quantities. It in
42、cludes all electrical circuits in use during the period of patient contact up to and including any SEPARATION DEVICE(S). 2.102 DETECTOR ASSEMBLY: The RADIATION DETECTOR and all other parts to which the RADIATION DETECTOR S permanently attached, except the MEASURING ASSEMBLY. Page 7 EN 60601-2-9 : 19
43、96 2.103 RADIATION DETECTOR: For this standard this is defined as the electrically operated element which directly transduces ABSORBED DOSE, ABSORBED DOSE RATE or any other dose related quantity, into a measurable electrical signal. 2.104 (PATIENT CONTACT) DOSEMETER: RADIATION METER used for the mea
44、surement On or in the PATIENT Of ABSORBED DOSE, ABSORBED DOSE RATE, Or any dose-related qUantitieS in IONISING RADIATION, Such as EXPOSURE O KERMA. This EQUIPMENT Usually COnSiStS Of One Or more RADIATION DETECTOR ASSEMBLIES (for example CHAMBER ASSEMBLIES) and a MEASURING ASSEMBLY. 2.105 ACCESSIBLE
45、 CONDUCTIVE PARTS: Conducting parts Of EQUIPMENT which can be touched without the use of a tool. 2.106 DISINFECTABLE EQUIPMENT: EQUIPMENT parts which come nt0 contact With the PATIENT during normal use and which may be disinfected in accordance with the MANUFACTURERS instructions. 2.107 CTERILIZABLE
46、 EQUIPMENT: EQUIPMENT parts Which come nt0 Contact with the PATIENT during normal use and which may be sterilized in accordance with MANUFACTURERS instructions. 5 Classification This clause of the General Standard applies except as follows: 5.3 Amendment: MEASURING ASSEMBLY is not specially protecte
47、d against the ingress of liquids. 5.6 Amendment: Delete all but CONTINUOUS OPERATION. - I E - e For the APPLIED PART Only, delete all but WATERTIGHT EQUIPMENT. Unless otherwise stated, the - _. - * Ln * 6 Identification, marking and documents This clause of the General Standard applies except as fol
48、lows: 6.1 Marking on the outside Of EQUIPMENT and EQUIPMENT parts Additional items: aa) The only information required to be clearly marked on the DETECTOR ASSEMBLY or on a permanently affixed label is: - the indication of origin; - the model or type number; - the serial number; particular models of
49、suitable MEASURING ASSEMBLIES may be referred to in the warning. bb) The following additional information shall be clearly marked on the MEASURING ASSEMBLY: - an indication Of the types or models Of DETECTOR ASSEMBLY With which the MEASURING ASSEMBLY makes a complete EQUIPMENT which meets the requirements of this standard. 1 STD-BSI BS EN bObOL-2-7-ENGL 1777 Lb24bhl OL2048L OqL( W Page 8 EN 60601-2-9 : 1996 6.8 ACCOMPANYING DOCUMENTS 6.8.2 Instructions for use Additional item: aa) The instructions for use shall i
