JIS-T-1603-1989-ENG.pdf

J I S T%1b03 89 I 4933608 00713127 4 E 1 I UDC 61 5.81 6-78:621.65-83:612.1 JAPANESE INDUSTRIAL STANDARD a a Electric Motor Driven Blood Pump for Cardiopulmonary Bypass JIS T 1 6 0 3 - 1 9 8 9 Translated and Published by Japanese Standards Association Printed in Japan 7 s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- I JIS Tulb03 89 = 4933b08 0071328 b In the event of any doubt arising, the original Standard in Japanese is to be final authority. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T81b03 89 9 4933608 0071329 8 ' U UDC 615.816-78:621.65-83:612.1 JAPANESE INDUSTRIAL STANDARD J I S Electric Motor Driven Blood Pump for T 1603-1989 Cardiopulmonary Bypass 1. Scope This Japanese Industrial Standard specifies the roller type blood pump with electric motor as power source, hereinafter, referred to as “blood pump“, among the blood pumps of cardiopulmonary bypass devices with extra corporeal circulatory function for the purpose of life support mainly during cardiotomy. Remark: The units and numerical values given in based on the traditional units and are currently the criteria in force. in this Standard are 2. Definitions For the purpose of this Standard, the following definitions apply. Other terms and definitions are specified in JIS T 1001. (1) a roller pump the pipe for pump to move by pulse pressing to delivery direction and eject the blood in constant qùantity in closed state. That of structure in which the roller pushes to pressurize roller to have constant rotating radius by rotating axis fixed to the pump axis. pump head rotation of roller. That of structure of cylinder shape fixed to rotating axis so as The part to fix the pipe for pump and eject the blood by pump axis from electric motor. Axis to rotate through the transmission mechanism or the like pump peripheral wall roller. Circular wall to hold a constant clearance with pipe for pump roller pump. . Rubber pipe, vinyl pipe or elastic pipe to be used for pressing closeness against pump peripheral wall. Degree of pressing in pulse the pipe for pump of rol-ler 3. Conditions of Use Applicable Standards, Reference Standard and Relating Law and Regulation: See page 9. a The conditions of use shall be as follows. (1) Working Environment The working environment of blood pump shall comply . with the specification of 3.(1) of JIS T 1001. (2) Storage Environment The storage environment of blood pump shall comply with the specification of 3.(2) of JIS T 1001. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*1b03 ô9 4933608 0071330 4 m 2 T 1603-1989 4. Classification In the case where the blood pumps are divided by number of rollers, the following apply. ( 1 ) Single Roller Pump That with one roller. (2) Double Roller Pump That with two rollers. (3) Multi-Roller Pump That with 3 or over rollers. 5. Safetv The items relating to safety shall comply with the following and other items are specified in JIS T 1001. (1) The type and degree of protection against electric shock shall comply with the following sorts specified in JIS T 1001 in each. (a) Sorts by Type of Protection against Electric Shock or class II equipment Class I equipment (b) Sorts by Degree of Protection against Electric Shock or BF type equipment B type equipment (2) The withstand voltage shall comply with (A - a), (A - f ) and (B - a) speci- fied in Table 2 of 6.3.2 of JIS T 1001. However, as for (B - a), it is that between the power source terminal and content liquid of pipe for pump. (3) The outer package shall have no projection, burr, etc. liable to damage the pipe for pump. 6. Performance 6.1 Pressing Closeness of Roller When the test is conducted according to 8.3.1, the drop number shall be 1 to 15 drops per min. 6.2 Rotating Performance of Blood Pumps The rotating performance of blood pump shall be as follows. (i) Error of Revolving Speed of Blood”Pumps according to 8.3.2 (i), the error of revolving speed per min indicated in the revolving speed indicating device, hereinafter, ref erred to as “revolving speed”, shall be Irregularity of Revolving Speed of Blood Pump ducted according to 8.3.2 (2), there shall be no irregularities injurious to practical use. When the test is conducted 5 % of actually measured revolving speed. (2) When the test is con- (3) Variation of Revolving Speed of Blood Pump by Variation of Power Source Voltage When the test is conducted according to 8.3.2 (3), the variation of revolving speed against the variation of 2 10 % of rated voltage shall be t 10 % of rated revolving speed. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*lb03 87 4733608 0073333 b 1 3 T 1603-1989 i- l, (4) Variation of Revolving Speed of Blood Pump by Continuous Operation When the test is conducted according. to 8.3.2 (41, the variation of re- volving speed at completion of test ;hall be 2 5 % of revolving speed at initiation of test. (5) Variation of Revolving Speed of Blood Pump by Load Variation When the test is conducted according to 8.3.2 (5), the variation of revolving speed at loading shall be 2 10 % of revolving speed at no load. (6) Flow Rate Error of Blood Pump indicating device of blood, when the test is conducted according to 8.3.2 (6), the error of flow rate indicated on the flow rate indicating device shall be f 5 % of actually measured flow rate. In the blood pump with flow rate 6.3 Noise When the test is conducted according to 8.3.3, the noise per one b l o o d m p shall be 50 dB or under. 6.4 Temperature When the test is conducted according to 8.3.4, it shall not exceed the value specified in Table 5 of JIS T 1001. ature of every part of pump head shall be 55°C or under. However, the temper- 7, Construction and Structure 7.1 Construction The construction of blood pump shall be as follows. (1) Pump Head The pump head shall be constructed with pump axis, rotating axis, roller, pump peripheral wall, pipe for pump fixing device, etc. (2) Driving Part The driving part shall be constructed with electric motor, transmitting mechanism from electric motor, revolving speed control device, revolving speed indicating device, electric power source circuit, etc. 7.2 Structure 7.2.1 Pump Head The structure of pump head shall be as follows. (1) The pump head shall be manufactured solidly, shall. use materials not to change even in use for a long period and shall be of structure able to be set by always stable method on the floor of using place such as operating room and the like. (2) The pump head shall be equipped with cover so as to prevent erroneous invasion of other materials in the parts such as roller, pipe for pump, pump peripheral wall, etc. and to enable the observation of inner side. (3) The length of roller in axial direction shall be sufficient length required to close by pressing surely the pipe for pump in ordinary using con- dition. (4) The pump head shall be equipped with fixing device of pipe for pump so that the pipe for pump may not displace or move together with revolving of roller and the pipe for pump shall be structured so as not to get out of place from pump head during use. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- JIS Tulb03 89 I 4933608 0073332 B = 4 T 1603-1989 (5) The roller with mechanism to control1 the pressing closeness of pipe for pump shall not contact the pump peripheral wall when the pressing closeness has been made largest in the state not set with pipe for Pump- Further, after the pressing closeness has been controlled, a holding mechanism shall be equipped with to support the pressing closed state. The hand-working handle able to revolve easily the pump axis manually shall be equipped. The hand-working handle shall be of the structure able to be easily removed or to house so that the revolving may not be disturbed when the pump axis has begun to revolve by the return of power source from service interruption or the like. The pump head shall be of structure so that the driving part, and the like, may not be affected when the pump head has been splashed by liquid for a short time and in small amount. The pump axis shall be of structure so as not to be affected by exter- nal force in the case of movement of the cardiopulmonary bypass device, and the like. Driving Parts The structure of driving parts shall be as follows. Every roller pump shall be equipped with power source switch, power source indicating device, revolution control device and revolving speed indicating device and the revolving direction or liquid feeding direction shall be indicated. The revolving speed of blood pump shall be structured so as to be able to change easily the range from revolution stop up to rated largest revolving speed. The revolution control device when many blood pumps are used shall be able to identify the correspondence with pump head. The blood pump with mechanism able to change the revolving direction shall be of structure so that the revolving direction may not be re- versed erroneously in use. 8.1 Test Conditions The test conditions shall comply with the following. Other conditions shall comply with the specification of 4. of JIS T 1002. (i) Power Source for Test The power source for test shall comply with the specification of 3.3 of JIS T 1003. (2) Pipe for Pump The pipe for pump to be used in the blood pump in test shall be that shown in 10.(2). Further, in the case where the pipe for pump of two classes or over may be used, the pipe for pump generating the worst condition shall be mounted to test. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*3b03 89 4933b08 O073333 T H ' 5 T 1603-1989 (3) . Pressing Closeness of Pipe for Pump The pressing closeness of pipe for pump shall be appropriate pressing closeness satisfying 6.1 unless otherwise specified. (4) Other Conditions For the test, the water, physiologic saline solution, etc, shall be used and the liquid temperature shall be 35 i 2°C unless otherwise specified. 8.2 Tests Relating to Safety with the specifications of JIS T 1002, JIS T 1003 and JIS T 1004. The tests relating to the safety shall comply Further, among the tests of leakage current, for the earth leakage current and armour leakage current, 6.2 and 6.3 of JIS T 1003 shall apply and the patient leakage current-1 shall comply with Fig. 1. Fig. 1. Patient Leakage Current-1 Measuring Circuit to E Esteem this part as the equipping part / t o P 4 Specimen blood pump to P t o E r - Instrument for measurement Tank for test Copper plate (10 cm* or over) / P: power source connecting terminal E: earthing point PE: protective earth terminal Remark: Esteem the' connecting part of pipe for pump with roller etc. as equipping part and apply the specifications of 6.4 of JIS T 1003. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*lb03 89 O 4933608 007333Li l O 6 T 1603-1989 8.3 Performance Test 8.3.1 Pressing Closeness Test of Roller Stop the pump axis at optional position by the circuit shown in Fig. 2 and for every roller control the pressing closeness of roller so that the dropping may be 5 to 10 drops per min with using the water, physiologic saline solution, or the like to hold. Next, change the position of roller at interval 45 degrees or under to the pump peripheral wall to measure the number of drops. Fig. 2. Pressing Closeness Test Circuit of Roller Water, physiologic saline solution, or the l i k e Disposable blood transfusion set* Exclude the a i r bubbles as far as possible Pipe for pump Specimen blood pump Note *: According to the Notification of Ministry for Health and Welfare No. 301 of Year 1970: set and liquid transfusion set. Reference for disposable blood transfusion 8.3.2 performance of blood pump shall be conducted with using the test circuit shown in Fig. 3. Test of Revolving Performance of Blood Pump The test of revolving Further, the side pipe pressure on the ejection side shall be controlled to 10 kPa (0.1 kgf/cmz or over by circuit resistor able to control the sectional area of pipe for pump unless otherwise specified. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- C i JIS TxLb03 A ï E 4933b08 0073335 3 7 T 1603-1989 Fig. 3. Test Circuit for Revolving Performance of Blood Pump Pressure gauge rcuit resistor Water, physiologic saline solution, etc. Water tank for test Measuring cy1 inde Pipe for pump Specimen blood pump Informative Reference: As for pressure gauge, use Grade 1.5 specified in JIS B 7505 or that equivalent or superior to this in precision. Test of Revolving Speed Error of Blood Pump Revolve the blood pump with rated maximum revolving speed indicated in the revolving speed indicating device of blood pump, with of this revoling speed and or under of this revolving speed and determine in each the difference of actually measured revolving -speed and indicated one. Test of Revolving Irregularity of Blood Pump is revolved in+. or under of rated maximum revolving speed, test the existence of revolving irregularity by visual observation. When the blood pump 'rest of Revolving Speed Variation of Blood Pump by Power Source Voltage Variation its $ t 10 % and examine the variation of revolving speed, Revol