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YY 0645-2018: Continuous blood purification equipment
Status: Valid YY 0645: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0645-2018 | English | 199 |
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3 days [Need to translate]
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Continuous blood purification equipment
| Valid |
YY 0645-2018
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| YY 0645-2008 | English | 359 |
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3 days [Need to translate]
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Continuous blood purification equipment
| Obsolete |
YY 0645-2008
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PDF similar to YY 0645-2018
Standard similar to YY 0645-2018 YY/T 0663.2 YY/T 0640 YY 0948 YY 0267 Basic data | Standard ID | YY 0645-2018 (YY0645-2018) | | Description (Translated English) | Continuous blood purification equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,140 | | Date of Issue | 2018-01-19 | | Date of Implementation | 2019-01-01 | | Older Standard (superseded by this standard) | YY 0645-2008 | | Quoted Standard | GB/T 191; GB 9706.1; GB 9706.2; GB/T 9969-2008; GB/T 13074; GB/T 14710-2009; YY/T 0466.1; YY 0054-2010; YY 0709 | | Regulation (derived from) | China Food and Drug Administration announced No. 8 of 2018 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions, classifications and markings, requirements, test methods, signs, instructions for use and packaging, transportation, and storage of continuous blood purification equipment. This standard applies to continuous blood purification equipment (hereinafter referred to as equipment). The device does not have replacement fluid or dialysate preparation function, and can be used for continuous blood purification treatment such as hemofiltration over 24 hours. This standard does not apply to: water treatment devices; peritoneal dialysis devices; devices with only blood perfusion mode; devices with only plasma treatment modes; hemodialysis devices; other devices with replacement fluid or dialysate preparation capabilities. | YY 0645-2018: Continuous blood purification equipment---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.
Continuous blood purification equipment
ICS 11.040.30
C45
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0645-2008
Continuous blood purification equipment
Published on.2018-01-19
2019-01-01 implementation
State Food and Drug Administration issued
Foreword
The full technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0645-2008 "continuous blood purification equipment", compared with YY 0645-2008, the main technical changes are as follows.
--- Further clarified the scope of application of the standard;
--- Normative references added YY 0709 and YY 0054-2010;
--- Redefine the terms of dehydration and equipment liquid balance error to make the definition more accurate;
--- Modified the description of the classification and marking;
--- Appropriate adjustments to the restrictions on normal working conditions;
---Modified blood pump flow accuracy, air entry protection system requirements and test methods;
---Modified dialysate pump flow, replacement fluid pump flow, equipment dehydration error alarm, transmembrane pressure protection system, network power supply interruption,
The expression of air entering the protection system requirements;
--- Fixed the requirements and test methods for heparin pumps;
--- Increased blood leakage protection system, weighing scale, prevention or prevention of replacement fluid bag/dialysate bag evacuation requirements and test methods;
--- Added the requirement of YY 0709 in the security requirements;
--- Revised the requirements for signs, instructions, packaging, transportation and storage.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158).
This standard was drafted. Guangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration, Chongqing Shanwaishan Technology Co., Ltd.
the company.
The main drafters of this standard. Wu Shaohai, Wang Peilian, Chen Jialu, Fan Xiang, Gao Guangyong, Yu Qinghong.
The previous versions of the standards replaced by this standard are.
---YY 0645-2008.
Continuous blood purification equipment
1 Scope
This standard specifies the terms and definitions, classification and marking, requirements, test methods, signs, instructions for use of continuous blood purification equipment.
And packaging, transportation, storage.
This standard applies to continuous blood purification equipment (hereinafter referred to as equipment). The device does not have a replacement fluid or dialysate preparation function, and
It can be used for blood purification treatment such as hemofiltration for 24 hours or more.
This standard does not apply to.
---Water treatment device;
---Peritoneal dialysis equipment;
--- Equipment with only blood perfusion mode;
--- Equipment with only plasma therapy mode;
---hemodialysis equipment;
--- Other equipment with replacement fluid or dialysate preparation function.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation pictorial signs (GB/T 191-2008, ISO 780.1997, MOD)
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1.1988, IDT)
GB 9706.2 Medical electrical equipment - Part 2-16. Safety specific to hemodialysis, hemodiafiltration and hemofiltration equipment
Seeking (GB 9706.2-2003, IEC 60601-2-16..1998, IDT)
GB/T 9969-2008 General instructions for the use of industrial products
GB/T 13074 blood purification terminology
GB/T 14710-2009 Environmental requirements and test methods for medical appliances
YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1 . General requirements
(YY/T 0466.1-2016, ISO 15223-1.2012, IDT)
YY 0054-2010 Hemodialysis equipment
YY 0709 Medical electrical equipment - Part 1-8. Safety general requirements Parallel standard. General requirements, medical electrical equipment and medical
Testing and guidance for alarm systems in electrical systems (YY 0709-2009, IEC 60601-1-8.2003, IDT)
3 Terms and definitions
The following terms and definitions as defined in GB 9706.2 and GB/T 13074 apply to this document.
3.1
Dehydration amount fluidremoval
The difference between the total fluid output and the total liquid intake at a given time.
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