1、BSI Standards PublicationMedical electrical equipmentPart 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipmentBS EN 60601-2-65:2013National forewordThis British Standard is the UK implementation of EN 60601-2-65:2013.It is identical to IEC
2、 60601-2-65:2012. It partially supersedes BS EN 60601-2-7:1998 and BS EN 60601-2-32:1995, which are withdrawn.BSI as a member of CENELEC is obliged to publish EN 60601-2-65 as a British Standard. However, attention is drawn to the fact that the UK national com-mittee voted against the UK implementat
3、ion of EN 60601-2-65, as it feels that provisions are not quite fit for purpose for those hand held devices that are new to the market with regards to assessing leakage radiation at the sur-face of the units.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electric
4、al Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this subcommittee 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
5、for its correct application. The British Standards Institution 2013Published by BSI Standards Limited 2013 ISBN 978 0 580 71523 5 ICS 11.040.50Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Pol
6、icy and Strategy Committee on 31 July 2013.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-65:2013EUROPEAN STANDARD EN 60601-2-65 NORME EUROPENNE EUROPISCHE NORM January 2013 CENELEC European Committee for Electrotechnical Standardization Comit Europen d
7、e Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-65:2013 E ICS 11.040.50 Supersed
8、es EN 60601-2-7:1998 (partially), EN 60601-2-32:1994 (partially) English version Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (IEC 60601-2-65:2012) Appareils lectromdicaux - Partie 2-65: Exigence
9、s particulires pour la scurit de base et les performances essentielles des appareils rayonnement X dentaires intra-oraux (CEI 60601-2-65:2012) Medizinische elektrische Gerte - Teil 2-65: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von intraoralen zahnrzt
10、lichen Rntgeneinrichtungen (IEC 60601-2-65:2012) This European Standard was approved by CENELEC on 2012-10-24. 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
11、alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other lang
12、uage made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the
13、 Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the Unite
14、d Kingdom. BS EN 60601-2-65:2013EN 60601-2-65:2013 - 2 - Foreword The text of document 62B/889/FDIS, future edition 1 of IEC 60601-2-65, prepared by IEC/SC 62B “Diagnostic imaging equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and ap
15、proved by CENELEC as EN 60601-2-65:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-07-24 latest date by which the national standards conflicting with the docum
16、ent have to be withdrawn (dow) 2015-10-24 This document supersedes EN 60601-2-7:1998 (PART) and EN 60601-2-32:1994 (PART). EN 60601-2-65:2013 includes the following significant technical changes with respect to EN 60601-2-7:1998 and EN 60601-2-32:1994: Within its specific scope, the clauses of EN 60
17、601-2-65:2012 supersede and replace those of EN 60601-2-7:1998 and EN 60601-2-32:1994. This standard is to be read in conjunction with EN 60601-1:2006. In this standard, the following print types are used: - Requirements and definitions: roman type. - Test specifications: italic type. - Informative
18、material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. - TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this stand
19、ard, the term - “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.), - “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). Refe
20、rences to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the co
21、nditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: - “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; - “sho
22、uld” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; - “may” is used to describe a permissible way to achieve compliance with a requirement or test. BS EN 60601-2-65:2013- 3 - EN 60601-2-65:2013 An asterisk (*) as the first ch
23、aracter of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be h
24、eld responsible for identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 60601-2-65:2012 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for th
25、e standards indicated: IEC 60601-2-7:1998 NOTE Harmonised as EN 60601-2-7:1998 1)(not modified). IEC 60601-2-28:2010 NOTE Harmonised as EN 60601-2-28:2010 (not modified). IEC 60601-2-32:1994 NOTE Harmonised as EN 60601-2-32:1994 1)(not modified). IEC 60601-2-43:2010 NOTE Harmonised as EN 60601-2-43:
26、2010 (not modified). IEC 60601-2-44:2009 NOTE Harmonised as EN 60601-2-44:2009 (not modified). IEC 60601-2-45:2011 NOTE Harmonised as EN 60601-2-45:2011 (not modified). IEC 60601-2-54:2009 NOTE Harmonised as EN 60601-2-54:2009 (not modified). IEC 60601-2-63 NOTE Harmonised as EN 60601-2-63. 1)Supers
27、eded by EN 60601-2-54:2009 (IEC 60601-2-54:2009, not modified). BS EN 60601-2-65:2013EN 60601-2-65:2013 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively reference
28、d in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modificatio
29、ns, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 and IEC 60601-1-3 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requireme
30、nts for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral S
31、tandard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corr. March 2008 2010 Add to Annex ZA of EN 60601-1:2006 the following new references: IEC 60336 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots EN 60336 - IEC/TR
32、60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 62220-1 2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency EN 62220-1 2004 BS EN 60601-2-65:2013 2 60601-2-65 IEC:2012 CONTENTS IN
33、TRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 10 201.7 ME EQUIPMENT identification,
34、marking and documents . 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 14 201.10 Protection against unwanted and excessive radiation HAZARDS 14 201.11 Protection against excessive temperatures and other H
35、AZARDS 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs 15 201.13 HAZARDOUS SITUATIONS and fault conditions . 15 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15 201.15 Construction of ME EQUIPMENT . 15 201.16 ME SYSTEMS 15 201.17 Electromagnetic comp
36、atibility of ME EQUIPMENT and ME SYSTEMS 15 202 Electromagnetic compatibility Requirements and tests . 15 203 Radiation protection in diagnostic X-ray equipment . 16 Annexes . 26 Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT and ME SYSTEMS 27 Annex AA (informative
37、) Particular guidance and rationale 28 Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in relation to defined terms in this standard 35 Bibliography 37 Index of defined terms used in this particular standard 40 Figure AA.1 AIR KERMA during IRRADIATION with direct cu
38、rrent X-RAY GENERATOR . 29 Figure AA.2 AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 31 Figure AA.3 Waveform of long IRRADIATION TIME X-RADIATION from a ONE-PEAK X-RAY GENERATOR 32 Figure BB.1 Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT 35 Figure BB.2 Parts of DENTAL INTRA-ORAL X-RA
39、Y EQUIPMENT 36 Table 201.101 List of potential ESSENTIAL PERFORMANCE to be considered by MANUFACTURER in the RISK MANAGEMENT PROCESS 10 Table 201.C.101 Marking on the outside of ME EQUIPMENT or its parts . 27 Table 201.C.102 Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 27 BS EN 60601-
40、2-65:201360601-2-65 IEC:2012 5 INTRODUCTION This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for DENTAL INTRA-ORAL X-RAY EQUIPMENT. While the previously existing standards for s
41、uch equipment were dedicated to components and subsystems, this particular standard addresses the system level of DENTAL INTRA-ORAL X-RAY EQUIPMENT. Components and their functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered
42、to provide for a practical degree of safety in the operation of DENTAL INTRA-ORAL X-RAY EQUIPMENT. The minimum safety requirements for DENTAL EXTRA-ORAL X-RAY EQUIPMENT are specified in a separate particular standard IEC 60601-2-63 to simplify and improve the readability This particular standard ame
43、nds and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for safety and essential performance, hereinafter referred to as the general standard. Within its specific scope, the clauses of this particular standard supersede and replace those of IE
44、C 60601-2-7, Medical electrical equipment Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators. Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard I
45、EC 60601-2-28, IEC 60601-2-7 or IEC 60601-2-32 have been extracted and moved into this particular standard. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to equipment in the scope of this International St
46、andard. BS EN 60601-2-65:2013 6 60601-2-65 IEC:2012 MEDICAL ELECTRICAL EQUIPMENT Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment 201.1 Scope, object and related standards Clause 1 of the general standard1applies, except as follow
47、s: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT. The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY
48、contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY. DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY MONOBLOCK ASSEMBLY. Therefore in this particular standard the concept of X-RAY TUBE
49、ASSEMBLY is replaced by that of X-RAY MONOBLOCK ASSEMBLY. NOTE 2 Main components may be for instance the X-RAY MONOBLOCK ASSEMBLY and an ELECTRONIC X-RAY IMAGE RECEPTOR. NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard, since they have no electrical APPLIED PARTS in the PATIENT ENVIRONMENT, and are not ME EQUIPMENT. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45 or IEC 60
