1、BRITISH STANDARD BS EN 60601-2-36: 1997 IEC 60601-2-36: 1997 BS 5724-2-36: 1997 Medical electrical equipment Part 2: Particular requirements for safety Specification for equipment for extra-corporeally induced lithotripsy The European Standard EN 60601-2-36:1997 has the status of a British Standard
2、ICS 11.040.60BSEN 60601-2-36:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityof the Standards Boardand comes into effect on 15August 1997 BSI 09-1999 ISBN 0 580 27566 3 National foreword This British Stan
3、dard is the English language version of EN60601-2-36:1997. It is identical with IEC60601-2-36:1997. The UK participation in its preparation was entrusted to Technical Committee CH/94, Physical and electrotherapeutic equipment, which has the responsibility to: aid enquirers to understand the text; pr
4、esent to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can
5、 be obtained on request to its secretary. Cross-references Attention is drawn to the fact that Annex ZA lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications referred
6、 to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contrac
7、t. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages 2 to 14 an
8、d a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSEN 60601-2-36:1997 BSI 09-1999 i Contents Page National f
9、oreword Inside front cover Foreword 2 Text of EN 60601-2-36 3ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-36 May 1997 ICS 11.040.60 Descriptors: Medical electrical equipment, equipment for lithotripsy, safety requirements, protection against electric shock, protection against
10、 mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997) Appareils lectromdicaux Partie 2: Rgles particul
11、ires de scurit des appareils pour lithotritie cre de faon extra-corporelle (CEI 60601-2-36:1997) Medizinische elektrische Gerte Teil 2: Besondere Festlegungen fr die Sicherheit von Gerten zur extrakorporal induzierten Lithotripsie (IEC 60601-2-36:1997) This European Standard was approved by CENELEC
12、on 1997-03-11. 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 concerning such national standards m
13、ay 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 into its own language and notified t
14、o 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, Spain, Sweden, Switzerland and Unit
15、ed 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 1997 CENELEC All rights of exploitation in any form and by any means r
16、eserved worldwide for CENELEC members. Ref. No. EN 60601-2-36:1997 EEN 60601-2-36:1997 BSI 09-1999 2 Foreword The text of document62D/211/FDIS, future edition1of IEC60601-2-36, prepared by SC 62D, Electromedical equipment, of IECTC62, Electrical equipment in medical practice, was submitted to the IE
17、C-CENELEC parallel vote and was approved by CENELEC as EN60601-2-36 on 1997-03-11. The following dates were fixed: 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 Annex A
18、A and Annex ZB are informative. Annex ZA and Annex ZB have been added by CENELEC. Endorsement notice The text of the International Standard IEC60601-2-36:1997 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 Introduction 3 Section 1. General 1 Scope a
19、nd object 3 2 Terminology and definitions 4 6 Identification, marking and documents 5 Section 2. Environmental conditions 10 Environmental conditions 6 Section 3. Protection against electric shock hazards 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 6 20 Dielectric strength 6 Page S
20、ection 4. Protection against mechanical hazards 21 Mechanical strength 6 22 Moving parts 8 24 Stability in NORMAL USE 8 26 Vibration and noise 8 28 Suspended masses 8 Section 5. Protection against hazards from unwanted or excessive radiation 35 Acoustical energy (including ultrasonics) 9 36 Electrom
21、agnetic compatibility 9 Section 7. Protection against excessive temperatures and other safety hazards 42 Excessive temperatures 9 49 Interruption of the power supply 9 Section 8. Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data 9 51 Protection against
22、hazardous output 10 Section 10. Constructional requirements 10 54 General 10 56 Components and general assembly 10 57 MAINS PARTS, components and layout 11 Appendix L References Publications mentioned in this Standard 12 Annex AA (informative) General guidance and rationale 12 Annex ZA (normative) N
23、ormative references to international publications with their corresponding European publications 14 Annex ZB (informative) Normative references to international publications with their corresponding European publications 14 Table 1 Static stress 7 Table 2 Dynamic stress 7 Table 3 Buckling, shock and
24、 impact load 7 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 1997-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 1997-12-01EN 60601-2-36:1997 BSI 09-19
25、99 3 Introduction This Particular Standard supplements IEC601-1(second edition,1988) Medical electrical equipment Part1: General requirements for safety, and its amendments1(1991) and2(1995), hereinafter referred to as the General Standard (see1.3). The requirements are followed by specifications fo
26、r the relevant tests. Following the decision taken by subcommittee62D at the meeting in Washington in1979, a “General guidance and rationale” section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex AA. Clauses or subclauses for which there
27、 are explanatory notes in Annex AA are marked with an asterisk (*). It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the Standard but will, in due course, expedite any revision necessitated by changes in clinical practice or a
28、s a result of developments in technology. However, this annex does not form part of the requirements of this Standard. 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
29、as follows: 1.1 Scope Addition: This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in2.1.101. The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited t
30、o, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC sta
31、ndards. While this Particular Standard has been developed for EQUIPMENT intended for use in LITHOTRIPSY, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standa
32、rd may be used as a guideline. 1.2 Object Addition: This Particular Standard specifies requirements for the safety of EQUIPMENT for EXTRA-CORPOREALLY INDUCED LITHOTRIPSY. 1.3 Particular Standards Addition: This Particular Standard refers to IEC601-1(1988): Medical electrical equipment Part 1: Genera
33、l requirements for safety, and its amendments1(1991) and2(1995). For brevity, Part1is referred to in this Particular Standard either as the “General Standard” or as the “General Requirement(s)”. The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the
34、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 the text of this Particular Standard. “Addition” means that the text of this Particula
35、r Standard is additional to the requirements of the General Standard.EN 60601-2-36:1997 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 Gen
36、eral Standard are numbered starting from101, 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. The requirements of this Particular Standard take pri
37、ority over those of the General Standard. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard applies without modification. Where it is intended that part of the General Standard, although possibly applica
38、ble, should not apply to EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY, this is indicated in this Particular Standard. If equipment such as lasers or explosive agents are used for the generation of extracorporeally induced PRESSURE PULSES, additional reference is made to the applicable Particul
39、ar Standards. 2 Terminology and definitions This clause of the General Standard applies except as follows: 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES Additional definition: 2.1.101 EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY (hereinafter referred to as EQUIPMENT) device for treatment wi
40、th extracorporeally generated PRESSURE PULSES 2.12 Miscellaneous Additional definitions: 2.12.101 LITHOTRIPSY comminution or fragmentation of calculi 2.12.102 EXTRACORPOREALLY INDUCED LITHOTRIPSY LITHOTRIPSY inside the PATIENT by PRESSURE PULSES generated outside the PATIENT 2.12.103 PRESSURE PULSE
41、acoustic wave emitted by the LITHOTRIPSY EQUIPMENT 2.12.104 PRESSURE PULSE COUPLING any means allowing transition of the PRESSURE PULSE from the EQUIPMENT into the PATIENT 2.12.105 FOCAL VOLUME volume in space contained within the surface defined by the 6 dB isobar of the maximum peak compressional
42、acoustic pressure 2.12.106 LOCALIZATION DEVICE* device used to determine the position of the calculi in (three-dimensional) space 2.12.107 TARGET LOCATION location in space where the MANUFACTURER intends the OPERATOR to locate the calculi 2.12.108 POSITIONING DEVICE device which brings the calculi i
43、nto coincidence with the TARGET LOCATIONEN 60601-2-36:1997 BSI 09-1999 5 2.12.109 TARGET MARKER marker which is used to indicate the TARGET LOCATION 6 Identification, marking and documents This clause of the General Standard applies except as follows: 6.3 Marking of controls and instruments Addition
44、al subclause: 6.3.101 Wireless remote control If the EQUIPMENT is provided with a wireless remote control device, such device shall be clearly marked as to its purpose and function. 6.8 ACCOMPANYING DOCUMENTS 6.8.2 Instructions for use 6.8.2 a) General information* Addition: Time intervals for maint
45、enance purposes need not be specified in the instructions for use if indication means (e.g.discharge counter) are provided on the EQUIPMENT and the purpose of these indication means is explained in the instructions for use. In particular, advice, when appropriate, shall be given on the following: 1)
46、 Description of the relevant safety precautions to be used to avoid SAFETY HAZARDS, e.g.the danger resulting from delivering PRESSURE PULSES to organs which contain gas. 2) Caution that PRESSURE PULSES may cause unwanted cardiac activity. 3) When using ECG monitoring equipment to trigger the generat
47、ion of the PRESSURE PULSE, only those ECG monitors specified by the MANUFACTURER of the EQUIPMENT shall be used. 4) Caution that the OPERATOR shall check the position of the calculi as often as necessary to ensure proper treatment. 5) Description of the schedule and measures to be performed within t
48、he scope of a regular performance check*. 6) Description concerning the correct use of the PRESSURE PULSE COUPLING including a reminder that it shall be free of bubbles. 7) Reminder that the PRESSURE PULSE is attenuated during passage through tissue, and that additional energy is absorbed by bone. 8
49、) Reminder that, even if anti-collision devices are installed, the OPERATOR shall always watch for any movements that may cause danger to the PATIENT or OPERATOR. 6.8.3 Technical description* Addition: The minimum technical description of the EQUIPMENT should contain, for example: a) positional precision of the TARGET MARKER with respect to the TARGET LOCATION; b) position and size of the FOCAL VOLUME with respect to the TARGET LOCATION; c) peak compressional and rarefactional acoustic pressures; d) energy per pulse.EN 60601-2-36
