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YY/T 1145-2014: Terms of cardiopulmonary bypass systems
Status: Valid YY/T 1145: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1145-2014 | English | 399 |
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3 days [Need to translate]
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Terms of cardiopulmonary bypass systems
| Valid |
YY/T 1145-2014
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| YY/T 1145-2003 | English | 639 |
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5 days [Need to translate]
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Terms of artificial heart-Lung machine
| Obsolete |
YY/T 1145-2003
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PDF similar to YY/T 1145-2014
Basic data | Standard ID | YY/T 1145-2014 (YY/T1145-2014) | | Description (Translated English) | Terms of cardiopulmonary bypass systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 01.040.11 | | Word Count Estimation | 17,148 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 1145-2003 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the relevant terms cardiopulmonary bypass system. This Standard for cardiopulmonary bypass system and related research, design, production, use, maintenance, management, teaching units. | YY/T 1145-2014: Terms of cardiopulmonary bypass systems---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Terms of cardiopulmonary bypass systems
ICS 01.040.11
C45
People's Republic of China pharmaceutical industry standards
Replacing YY/T 1145-2003
Cardiopulmonary bypass systems -
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
1 Scope 1
Annex 2 Common and related terms 1
3 artificial heart-lung machine 2
4 cardiopulmonary bypass system (passive part) 5
Index 9
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Instead of the standard YY/T 1145-2003 "term artificial heart-lung machine." The main technical difference compared with YY/T 1145-2003
as follows.
--- Standard name has been modified, and a greater change in the standard structure, the structure is divided according to product, sub
For the "common and accessories related terms," "artificial heart-lung machine" and "cardiopulmonary bypass system (passive part)" three broad categories, and in this
Under the framework of the terms detailed description.
--- According to the change in recent years and new clinical applications of new products, changed part of the name and description of the specific terms, an increase of "primary
Pump "," auxiliary pump "," artificial heart-lung machine control panel, "" dynamic blood gas monitoring device, "" empty oxygen blender "," left ventricular drainage tube "
"Suction tube chambers of the heart" and other terminology.
Please note that some of the content of this standard may involve patents. The standard release mechanism does not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
The standard equipment by the National Technical Committee of Standardization for medical cardiopulmonary bypass (SAC/TC158) centralized.
This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. He Xiaofan, Fan Xiang, Pei even.
The standard standard replaces the previous editions.
--- WS2-310-1984;
--- YY/T 91445-1999, YY/T 1145-2003.
Cardiopulmonary bypass systems -
1 Scope
This standard specifies the terms related to cardiopulmonary bypass system.
This standard cardiopulmonary bypass system and for related research, design, production, use, maintenance, management, teaching units.
Annex 2 Common and related terms
2.1
Cardiopulmonary bypass system cardiopulmonarybypasssystems
CPB, cardiopulmonary systems instead of the general term of.
Note. The term instead of YY/T 1145-2003 in the "artificial heart-lung machine."
2.2
Blood flow bloodflowrate
Unit time flowing blood pump blood volume, in mL/min indicated.
2.3
Holistic part integralpart
Devices connected to the body or together as part of the main body of the device, the user can not normally disassembled parts.
2.4
Blood path bloodpathway
CPB, the portion of blood through the device.
2.5
Blood cell destruction bloodceldamage
The cellular components of blood components is missing or damaged.
2.6
Priming volume primingvolume
Cardiopulmonary bypass, ensure the normal operation of the minimum amount of liquid.
2.7
Control variables operationvariables
It can affect the function of various devices controlled setpoint.
2.8
Tubing clamp tubingclamp
Fixed tubing member.
2.9
Oxygenator bracket oxygenatorholder
Oxygenator for fixing parts.
2.10
Emergency power emergencypowersupply
When the AC power supply system failure, timely maintenance of security auxiliary power unit Cardiopulmonary bypass the normal power supply system.
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