1、STD-BSI BS EN bObO2-2-3b-ENGL 1997 W 1bZYbbS Ob323b9 Li52 BRITISH STANDARD Medical electrical equipment Part 2. Particular requirements for safety - Specification for equipment for extra-corporeally induced lithotripsy * v1 * The European Stancard EN 60601-2-36 : 1997 has the status of a British Sta
2、ndard ICs 11.040.60 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 1997 1997 BS 5724-236 : 1997 60601-236 IEC 60601-236 : STD=BSI BS EN bObO1-2-3b-ENGL 1737 M 1b24bb7 Ob31370 173 BS EN 60601-236 : 1997 ThisBntishSbndard,having been prepared under the direciion of the He
3、alth and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 16 August 1997 O BSI 1997 NBN O 680 27666 3 National foreword This British standard is the English language vemion of EN 60601-236 : 1997. It is identical with IEC 60601-2-36 : 1997.
4、The UK participation in its prepamtion was entrusted to Technical Committee CIMM, Physical and electrotherapeutic equipment, which has the responsibiih - aid enquirem to undemtand the - present to the responsible internationai/Empean committee any enquiries on the interpretation, or proposals for ch
5、ange, and keep the K interests infOlTfl - monitor reW inteniational and European developments and promulgate them in the K. A list of organbtions represented on this committee can be obtained on request to its secretary, Cross-references Attention is drawn to the ad that annex ZA lists normative ref
6、erences to internationai publications with their conresponding European publications. “i EN 60601-2-36 : 1997 MEDICAL ELECTRICAL EQUIPMENT - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy SECTION ONE: GENERAL The clauses and subclauses of this se
7、ction of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard applies to the Safety Of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. The applicability o
8、f this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning
9、computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC standards. - II - - m I = * * While this Particular Standard has been developed for EQUIPMENT intended for use in zo LITHOTRIPSY, it has been developed such that, as long as no
10、other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standard may be used as a guideline. 1.2 Object Addition: This Particular Standard specifies requirements for the safety of EQUIPMENT for EXTRA- CORPOREALLY I
11、NDUCED LITHOTRIPSY. 1.3 Particular Standards Addition: This Particular Standard refers to IEC 601-1 (1988): Medical electrical equipment - Fart 7: General requirements forsafety, and its amendments 1 (1991) and 2 (1995). For brevity, Part 1 is referred to in this Particular Standard either as the “G
12、eneral Standard“ or as the “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 specified by the use of the following words: STD*BSI BS EN bOb01-2-3b-EN
13、GL 1997 Lb24bb7 Ob3L37b b9L W Page 6 EN 60601-2-36 : 1997 “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 Gener
14、al Standard. “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 from 101, additional annexes are lettered AA, BE, etc
15、., 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 priority over those of the General Standard. Where there is no corresponding section, claus
16、e 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 applicable, should not Particular Standard. apply to EQUIPMENT FOR EXTRACORPOREALLY INDUCED LIT
17、HOTRIPSY, this is indicated in this 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 Particular Standards. 2 Terminology and definitions This clause of the General Standard applies
18、except as follows: 2.1 EQUIPMENT parts, aUXilart?S and ACCESSORIES Additional definition: 2.1.101 EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY (hereinafter referred to as EQUIPMENT) Device for treatment with extracorporeally generated PRESSURE PULSES. 2.1 2 Miscellaneous Additional definitions
19、: 2.12.101 LITHOTRIPSY Comminution or fragmentation of calculi. 2.12.1 02 EXTRACORPOREALLY INDUCED LITHOTRIPSY LITHOTRIPSY inside the PATIENT by PRESSURE PULSES generated outside the PATIENT. STD-BSI BS EN bOb01-2-3b-ENGL 1797 W 1b24bb7 Ob31377 528 = Page 7 EN 60601-2-36 : 1997 2.12.103 PRESSURE PUL
20、SE Acoustic wave emitted by the LITHOTRIPSY EQUIPMENT. 2.12.1 04 PRESSURE PULSE COUPLING Any means allowing transition Of the PRESSURE PULSE from the EQUIPMENT nt0 the PATIENT. 2.12.105 FOCAL VOLUME Volume in space contained within the surface defined by the -6 dB isobar of the maximum peak compress
21、ional 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 CalCUh. 2.12.1 08 POSITIONING DEVICE Device which brings the
22、 calculi into coincidence with the TARGET LOCATION. - rn - = = = 2.12.109 TARGET MARKER - Marker which is used to indicate the TARGET LOCATION. 6 Identification, marking and documents * 2 This clause of the General Standard applies except as follows: 6.3 Marking of controls and instruments Additiona
23、l 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 mainte
24、nance purposes need not be specified in the instructions for use if indication means (e.9. discharge counter) are provided on the EQUIPMENT and the purpose of these indication means is explained in the instructions for use. STD=BSI BS EN bUbO1-2-3b-ENGL 1777 1b24bb7 Ob31378 4b4 = Page 8 EN 60601-2-3
25、6 : 1997 In particular, advice, when appropriate, shall be given on the following: 1) 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 un
26、wanted cardiac activity. 3) When using ECG monitoring equipment to trigger the generation of the PRESSURE 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
27、 the 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.
28、8) 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. PULSE, only those ECG monitors specified by the MANUFACTURER Of the EQUIPMENT shall 6.8.3 Technical description Addition: The minimum te
29、chnical 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
30、pulse. SECTION TWO: ENVIRONMENTAL CONDITIONS The clauses and subclauses of this section of the General Standard apply except as follows: 10 Environmental conditions This clause of the General Standard applies except as follows: 10.2.1 Environment Replacement: a) An ambient temperature range of +10 O
31、C to +30 OC. STD-BSI BS EN bDbOL-2-3b-ENGL 1777 = lb24bb7 Ub31377 3T0 Page 9 EN 60601-2-36 : 1997 SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS The clauses and subclauses of this section of the General Standard apply except as follows: 19 COntinUOUS LEAKAGE CURRENTS and PATIENT AUXILIARY
32、CURRENTS This clause of the General Standard applies except as follows: 19.1 General requirements 19.1 b) Addition to the third dash: The PATIENT LEAKAGE CURRENT shall not be measured during the PRESSURE PULSE release. 19.3 Allowable values Addition to note 3) of table IV: EQUIPMENT FOR EXTRACORPORE
33、ALLY INDUCED LITHOTRIPSY EQUIPMENT whose power supply is ensured via an industrial plug-in device and which is mechanically protected against unintentional disconnection should be regarded as permanently connected EQUIPMENT. 20 Dielectric strength This clause of the General Standard applies except a
34、s follows: 20.3 Values of test voltages Addition to table V: Voltages higher than 10 O00 V shall be tested with a factor of 1,2. SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS The clauses and subclauses of this section of the General Standard apply except as follows: 21 Mechanical strength This
35、 clause of the General Standard applies except as follows: 21.3 Addition: Table or PATIENT support extensions such as adjustable footboards shall be self-locking at all table or PATIENT Support tilt angles, as specified by the MANUFACTURER. Compliance with this requirement is checked by inspection.
36、STD-BSI BS EN bObUL-2-3b-ENGL 1797 lb24bb7 Ob31380 O12 Page 10 EN 60601-2-36 : 1997 Safety factors for construction classes Loading case Safety against C B A At rest Form change 1 ,i 13 1,4 1,6 187 22 (Rp 0-2 or Rp) Overload breakage 1,7 2,o 2,o 23 23 33 (Rm) a b a b a b Additional subclause: * 21.3
37、.101 Safety factor The safety factor indicates the ratio of a limit stress to the maximum stress occurring in operation. The safety factor shall always be equal to or greater than the values specified in tables 1 to 3. When calculating the strength of dynamically loaded components, all impairing inf
38、luences, such as notch effects, surface quality etc., have to be allowed for. The safety factor should be selected according to the possible consequences of a component failure according to 21.3.101.1. *21.3.1 01.1 Determination of the safety factor The safety factor should be selected according to
39、the following aspects: Construction class A: Failure of a component entails danger to the lives and health of persons. Construction class B: Failure of a component results in functional breakdown of the system. There is no danger to persons. Construction class C: Failure of a component results in a
40、relatively slight malfunction which can be eliminated quickly and easily. There is no functional breakdown of the cxrstem. There is no danyr ?o persons. Moreover, the construction classes A, B and C are subdivided as follows, in the case of static stress : a) Ascertainable stress NOTE - The values o
41、f the external forces or the stress to be expected are known. b) Not accurately. ascertainable stress NOTE -The values of the external forces or the stress to be expected can be estimated. Table 1 - Static stress * rn * Loading case Oscillating STD-BSI BS EN bOb01-2-3h-ENGL 1997 W lb24bb7 Ob31381 T5
42、9 Page 11 EN 60601-2-36 : 1997 Frequency of Safety factors for Safety against maximum load construction classes % C B A Endurance fracture 1 O0 13 2,O 2.3 75 1,5 1,8 2,1 50 14 1,6 1,9 25 1.3 1,s 1,7 A According to part 1 of EN 10002 the form change was based on the strain limit Rp 0,2 or elasticity
43、limit Rp and, for overload breakage, the tensile strength Rm, as limit of tension. ShocWimpact * Table 2 - Dynamic stress I C B A Overload breakage 4 6 8 Table 2 applies only for metallic materials. NOTE - For brittle materials, the safety factors should always be taken from the column Frequency of
44、maximum load 100 %“. Table 3 - Buckling, shock and impact load I Type of load I Safety against I Safety factors for construction classes 1 I I I Instability I 4 I 6 I 8 Buckling I 21.3.1 01.2 Special case For suspension devices made of steel (ropes, chains, belts), the safety factors are shown in cl
45、ause 28. 21.6 PORTABLE and MOBILE EQUIPMENT shall withstand the stress caused by rough handling. Replacement: Compliance is checked by the following test: MOBILE EQUIPMENT shall be moved forward using a contact as close as possible to the floor in its usual direction, at a speed to be specified by t
46、he MANUFACTURER, but not more than 0,l m/s, over a dimensionally stable obstacle which has a rectangular cross-section, 70 mm high by 80 mm wide, which is placed flat on the plane. The equipment shall operate normally after this test. 22 Moving parts This clause of the General Standard applies excep
47、t as follows: 22.3 Addition: This also applies for breakage of these parts. STD=BSI BS EN bObOL-2-3b-ENGL L777 3b2lrbb7 Ob33382 795 M Page a2 EN 60601-2-36 : 1997 22.4 Addition: Systems which have powered movements shall be designed to avoid excessive force being exerted on the PATIENT. EQUIPMENT mo
48、vements which may endanger the PATIENT during compression shall be prevented. 22.7 Addition after the fifth dash: 0 It shall be possible to free or reposition the PATIENT if the EQUIPMENT malfunctions. 0 Counterbalanced EQUIPMENT parts which may be set moving dangerously by removing accessory parts,
49、 shall be blocked and therefore made safe; the operating brake alone does not suffice. Accessory parts shall be secured against falling out in all operating positions. f. 24 Stability in NORMAL USE This clause of the General Standard applies except as follows: Addition: 24.101 During transportation, the EQUIPMENT shall not tilt over when a force amounting to 25 % of the EQUIPMENT mass or 220 N (it is sufficient to apply the smaller value) is applied. The direction and application point of the force shall be selected so that tilting over of the EQUIPMENT is favoured to the maximum.
