JIS-T-1603-1989-ENG.pdf
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1、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 Standard
2、s 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 S
3、tandard 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
4、 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, referr
5、ed 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. i
6、n 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 qantity in closed state.
7、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 axi
8、s 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. Degre
9、e 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 specificat
10、ion 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
11、/13/2007 02:40:48 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S T*1b03 9 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) D
12、ouble 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
13、 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 -
14、 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
15、 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
16、 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
17、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
18、. 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,
19、(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 Variatio
20、n 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 flo
21、w 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 excee
22、d the value specified in Table 5 of JIS T 1001. ature of every part of pump head shall be 55C 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 ax
23、is, 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 Struc
24、ture 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 a
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