YY/T 1730-2020Hemodialysis catheter for single use (English PDF)
一次性使用血液透析导管
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
June 1, 2021
Scope
YY/T 1730-2020 is the English-translated version of 一次性使用血液透析导管.
YY/T 1730-2020 is the Chinese pharmaceutical industry standard for the single-use haemodialysis catheter used in blood purification and related treatments.
It gives the terms and definitions, the classification, the requirements and the test methods, covering non-tunnelled catheters without a cuff and tunnelled catheters with one: the dimensions and the lumens and their flow and recirculation, the strength of the catheter and of its hub and extension lines, the clamps and caps, the radiopacity, the materials and their biological evaluation, and sterility. Issued on 30 June 2020, it has applied since 1 June 2021.
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Document preview — YY/T 1730-2020
National Standard of the People's Republic of China
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Categories
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.
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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.2Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB 8368Infusion sets for single use -- Gravity feed
- GB/T 13074Blood purification terminology
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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Related Standards
GB 8368-2018 — Infusion sets for single use -- Gravity feed
GB/T 13074-2024 — Blood purification terminology
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
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YY/T 1730-2020
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