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YY 0604-2016: Cardiopulmonary bypass systems - Blood-gas exchangers(oxygenators)
Status: Valid YY 0604: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0604-2016 | English | 339 |
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Cardiopulmonary bypass systems - Blood-gas exchangers(oxygenators)
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YY 0604-2016
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| YY 0604-2007 | English | 599 |
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Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
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YY 0604-2007
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PDF similar to YY 0604-2016
Basic data | Standard ID | YY 0604-2016 (YY0604-2016) | | Description (Translated English) | Cardiopulmonary bypass systems - Blood-gas exchangers(oxygenators) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 17,146 | | Date of Issue | 3/23/2016 | | Date of Implementation | 2018-01-01 | | Older Standard (superseded by this standard) | YY 0604-2007 | | Quoted Standard | GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 16886.1; GB 18279; GB 18280; GB 19335-2003; GB/T 19633-2005; YY/T 0466.1-2009; YY/T 0681.1-2009 | | Adopted Standard | ISO 7199-2009, MOD | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This International Standard specifies the requirements of a blood gas exchanger (oxygenator) (hereinafter referred to as "oxygenator") used in a sterile, disposable cardiopulmonary bypass system for supplying oxygen to human blood and removing carbon dioxide from the blood (Auxiliary or alternative to the respiratory function of the lungs of cardiopulmonary bypass devices). This standard also applies to heat exchangers as part of the whole oxygenator. This standard does not apply to: implantable oxygenator; liquid oxygenator; extracorporeal circulation pipeline; separate heat exchanger; separate accessories. | YY 0604-2016: Cardiopulmonary bypass systems - Blood-gas exchangers(oxygenators)---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.
Cardiopulmonary bypass systems - Blood-gas exchangers (oxygenators)
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0604-2007
Cardiopulmonary bypass system
Blood gas exchanger (oxygenator)
(ISO 7199..2009, Cardiovascularimplantsandartificialorgans-
Blood-gasexchangers (oxygenators), MOD)
2016-03-23 release
2018-01-01 implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
Classification and naming
5 requirements 3
5.1 Biological properties 3
5.2 Physical characteristics 3
5.3 Performance characteristics 3
5.4 Chemical properties 4
5.5 Valid 4
6 Test method 4
6.1 Overview 4
6.2 Biological performance test 4
6.3 Physical performance test 5
6.4 Performance characteristics test 5
6.5 Chemical properties test 7
6.6 Validity test 8
7 Information provided by the manufacturer 8
7.1 Information on Oxygenator 8
7.2 Description of the label on the packaging 8
7.3 User's Manual 9
7.4 Special note in random file 10
8 Packing 10
Appendix A (informative) The technical differences between this and ISO 7199..2009 and its causes 11
Reference 12
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard adopts the re-drafting method to modify ISO 7199..2009 "cardiovascular implants and artificial organs blood-gas exchangers (oxygenated
Device ".
The main technical differences between this standard and YY 0604-2007 are as follows.
--- increase the chemical performance, validity and other requirements and the corresponding test methods.
The main technical differences between this standard and ISO 7199..2009 are shown in Table A.1.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized.
The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Dongguan Kewei medical equipment
Limited, Maike Wei (Shanghai) Medical Equipment Co., Ltd.
The main drafters of this standard. Hong Liang Tong, Cheng Juan, Liang Canquan, Li Aijun, He Xiaofan, Liu Yisheng.
This standard replaced the previous version of the standard release.
--- WS2-299-1983, WS2-300-1983;
--- GB 12261-1990, GB 12262-1990;
--- YY 0604-2007.
Introduction
This standard is designed to effectively exchange gas, auxiliary or replace the lungs of the normal respiratory function of the device, to ensure its safety performance
And functional aspects are fully tested, and the characteristics of the cardiopulmonary device to be properly displayed on the device mark.
Therefore, this standard contains the steps to evaluate the cardiopulmonary bypass blood gas exchanger (oxygenator), which describes the measurement of gas conversion, blood
Cell failure and the performance of such devices, such as heat exchangers, but not the limits of these characteristics
set. The rapid identification of performance characteristics should help the user to select the oxygenator for the patient's needs.
This standard also covers the minimum requirements for the content that must be reported so that the user can add to the performance characteristics of the various standard oxygenators
To compare.
This standard refers to other international standards in which a method for determining the common characteristics of various medical devices can be found.
There was no provision for determining the number of microbubbles and the number of unformed components in bovine blood, which is due to the fact that
The test method has not yet reached a consensus.
This standard does not include requirements for animal and clinical research, which can be used as part of the manufacturer's quality system.
Cardiopulmonary bypass system
Blood gas exchanger (oxygenator)
1 Scope
This standard specifies the use of a blood gas exchanger (oxygenator) (hereinafter referred to as oxygenator) for a sterile, disposable cardiopulmonary bypass system
It is required that the device be used to oxygenate the blood of the human body and to remove carbon dioxide in the blood (auxiliary or alternative to the extracorporeal circulation of the lung
Device).
This standard also applies to heat exchangers as part of the overall oxygenator.
This standard does not apply to.
--- implantable oxygenator;
--- liquid oxygenator;
Extracorporeal circulation
Separate heat exchangers;
Separate accessories.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB 18279 Sterilization and routine control of ethylene oxide for medical devices (GB 18279-2000, idtISO 11135..1994)
GB 18280 Sterilization and routine control of health care products Requirements for radiation sterilization (GB 18280-2000, idtISO 11137.
1995)
General technical conditions for disposable blood use products GB 19335-2003
GB/T 19633-2005 Packaging of final sterilized medical devices (GB/T 19633-2005, ISO 11607..2003, IDT)
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009
(YY/T 0466.1-2009, ISO 15223..2007, IDT)
YY/T 0681.1-2009 Test methods for packaging of sterile medical devices - Part 1. Guidelines for accelerated aging testing (YY/T 0681.1-
2009, ASTM F1980..2002, MOD)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Blood gas exchanger (oxygenator) blood-gasexchanger (oxygenator)
Auxiliary or alternative to the respiratory function of the cardiopulmonary bypass dedicated device.
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