YY/T 1773-2021 English PDF

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YY/T 1773-2021: Disposable transfer line for peritoneal dialysis
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1773-2021	169	Add to Cart	3 days	Disposable transfer line for peritoneal dialysis	Valid

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Basic data

Standard ID: YY/T 1773-2021 (YY/T1773-2021)
Description (Translated English): Disposable transfer line for peritoneal dialysis
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Word Count Estimation: 9,910
Issuing agency(ies): State Drug Administration

YY/T 1773-2021: Disposable transfer line for peritoneal dialysis

---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 transfer line for peritoneal dialysis ICS 11.040 C45 People's Republic of China Pharmaceutical Industry Standards One-time use of peritoneal dialysis external tubing Released on 2021-03-09 2022-10-01 implementation Issued by the National Medical Products Administration

Table of contents

Foreword Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Structure composition 1 5 Requirements 2 6 Test method 4

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing agency of this document 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). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute. The main drafters of this standard. Ye Xiaoyan, He Xiaofan, Zhuang Ming, Dang Xiyun, Li Shengxia. One-time use of peritoneal dialysis external tubing

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 article Pieces. 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. ......

Image     

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