YY/T 1760-2021Disposable drainage system for peritoneal dialysis (English PDF)
一次性使用腹膜透析引流器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
March 1, 2023
Scope
YY/T 1760-2021 is the English-translated version of 一次性使用腹膜透析引流器.
YY/T 1760-2021 is the Chinese pharmaceutical industry standard for the single-use peritoneal dialysis drainage system, the set that joins the bag of dialysis fluid to the patient's catheter to run fluid into the abdomen and drain the spent fluid out.
It gives the terms and definitions, the structural composition, the requirements and the test methods, covering the protective caps, the connectors, the Y-piece, the inflow and outflow lines and the waste bag, their tightness and strength, the flow they allow, the materials and their biological evaluation, and sterility.
It does not cover the dialysis fluid itself, the peritoneal catheter or the transfer set. Issued on 6 September 2021, it has applied since 1 March 2023.
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Document preview — YY/T 1760-2021
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
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Structural 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, structural composition, requirements and tests of disposable peritoneal dialysis drainage devices (hereinafter referred to as drainage devices) method. The drainage device is connected with the peritoneal dialysis solution bag to form a complete set of peritoneal dialysis products, which are used for abdominal dialysis during peritoneal dialysis treatment.
Perfusion of membrane dialysate and drainage collection of dialysis waste. Usually composed of protective caps, connection interfaces, tee, perfusion pipeline, drainage pipeline and waste liquid collection It consists of a collection bag, excluding peritoneal dialysis fluid, dialysis catheter, outer tube and its packaging materials.
This standard applies to drainage devices in peritoneal dialysis.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.1 Syringes, injection needles and other medical devices - 6% (Luer) conical joints - Part 1: General requirements
GB/T 1962.2 Syringes, needles and other medical devices - 6% (Luer) conical connectors - Part 2: Locking connectors
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB/T 13074 Terms of Blood Purification
GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment - 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 Risk Management Process
YY 0267 Blood circuit for extracorporeal circulation of blood purification devices for hemodialysis and related treatments
YY/T 1556 Test method for particle contamination of medical infusion, blood transfusion and injection equipment YBB00122003 Determination of heat sealing strength Pharmacopoeia of the People's Republic of China
3 Terms and Definitions
Terms and definitions defined in GB/T 13074 apply to this document.
4 Structural composition
A typical schematic diagram of a single-use peritoneal dialysis drain is shown in Figure 1.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 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 1760-2021
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