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YY/T 1730-2020: (Disposable hemodialysis catheter)
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| YY/T 1730-2020 | English | 209 |
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(Disposable hemodialysis catheter)
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YY/T 1730-2020
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Basic data | Standard ID | YY/T 1730-2020 (YY/T1730-2020) | | Description (Translated English) | (Disposable hemodialysis catheter) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 11,152 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1730-2020: (Disposable hemodialysis catheter)---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.
(Disposable hemodialysis catheter)
ICS 11:040
C45
People's Republic of China Pharmaceutical Industry Standard
Disposable hemodialysis catheter
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that certain contents of this document may involve patents: Publication of this document
The agency is not responsible for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Standardization Technical Committee for Medical Extracorporeal Circulation Equipment (SAC/TC158):
Drafting organizations of this standard: Guangdong Medical Device Quality Supervision and Inspection Institute, Guangzhou Jianen Medical Equipment Co:, Ltd:, Guangdong Baihe Medical Branch
Technology Co:, Ltd:
The main drafters of this standard: He Xiaofan, Hu Xianghua, Liang Cuifang, Li Shi, Pan Muqiu, Xu Suhua:
Disposable hemodialysis catheter
1 Scope
This standard specifies the use of single-use hemodialysis catheters (hereinafter referred to as dialysis catheters) used in conjunction with blood purification and related treatments:
Terms and definitions, classification, requirements and test methods:
This standard applies to dialysis catheters used in conjunction with blood purification and related treatments, including non-tunnel and polyester-free catheters and tunnel belts
Polyester sleeve catheter: This standard does not include requirements for other accessories used with dialysis catheters:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 1962:2 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2: Locking joints
GB/T 6682 Analytical laboratory water specifications and test methods
GB 8368 Gravity infusion type disposable infusion set
GB/T 13074 Terminology for blood purification
GB/T 14233:1 Medical infusion, blood transfusion, and injection equipment inspection methods Part 1: Chemical analysis methods
GB/T 16886:1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management
YY 0030-2004 Peritoneal Dialysis Tube
YY 0267 Extracorporeal blood circuit of hemodialysis and related therapeutic blood purification device
YY 0285:1-2017 Sterile catheters for single use intravascular catheters Part 1: General requirements
YY/T 0586 Test method for X-ray opacity of medical polymer products
"The Pharmacopoeia of the People's Republic of China" (2015 edition) four volumes
3 Terms and definitions
The following terms and definitions defined in GB/T 13074 apply to this document:
3:1
Cuff
A section of ring (often made of polyester material) fixed on the dialysis catheter to facilitate tissue climbing, which helps the dialysis catheter to be implanted in the human body
After fixation, the tissue in the subcutaneous tunnel climbs to seal the collar, reducing the risk of in vitro microorganisms entering the patient's body through the outer wall of the catheter:
3:2
Effectivelength
The maximum length of the dialysis catheter (hydration catheter including pre-hydration and post-hydration) that can be inserted into the patient's body:
4 categories
Dialysis catheters are classified according to different structures of the catheters: Dialysis catheters can be divided into catheters without tunnels without polyester sleeves and catheters with tunnels with polyester sleeves:
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