YY/T 1773-2021Disposable transfer line for peritoneal dialysis (English PDF)
一次性使用腹膜透析外接管
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
October 1, 2022
Scope
YY/T 1773-2021 is the English-translated version of 一次性使用腹膜透析外接管.
YY/T 1773-2021 is the Chinese pharmaceutical industry standard for the single-use transfer line used in peritoneal dialysis, the short tube that joins the patient's peritoneal catheter to the dialysis fluid line or to its protective cap and controls the flow in and out.
It gives the terms and definitions, the structure and composition, the requirements and the test methods, covering the connectors and their aseptic joining and separation, the clamp and the flow it controls, the tightness and the strength of the assembly, the materials and their biological evaluation, and sterility. Issued on 9 March 2021, it has applied since 1 October 2022.
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Document preview — YY/T 1773-2021
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 Structure composition
- 5 Requirements
- 6 Test method
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions, structure and composition of the disposable peritoneal dialysis external tube (hereinafter referred to as the peritoneal dialysis external tube).
Requirements and test methods. The peritoneal dialysis external tube is used to connect to the end of the peritoneal dialysis catheter and the peritoneal dialysis fluid end line (or iodine solution protection Cap) perform aseptic connection and separation, and control the in and out of liquid.
This standard applies to peritoneal dialysis external tubing in peritoneal dialysis (including disposable external peritoneal dialysis tubing and external tubing for peritoneal dialysis). Connect the hose, etc.).
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 reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1: General requirements
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/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 15812.1-2005 Non-intravascular catheters Part 1: General performance test methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management
YY 0267 Extracorporeal circulation blood circuit of hemodialysis and related treatment blood purification devices
YY/T 1556 Inspection method for particulate contamination of medical infusion, blood transfusion and injection equipment Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The terms and definitions defined in GB/T 13074 are applicable to this document.
4 Structural composition
Figure 1 is a schematic diagram of a disposable peritoneal dialysis external tube.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
- 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/T 13074Blood purification terminology
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 15812.1-2005Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
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Related Standards
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
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
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YY/T 1773-2021
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