YY/T 1760-2021 English PDF

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YY/T 1760-2021: (Use an abdominal muscle drain)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1760-2021	219	Add to Cart	3 days	(Use an abdominal muscle drain)	Valid

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Basic data

Standard ID: YY/T 1760-2021 (YY/T1760-2021)
Description (Translated English): (Use an abdominal muscle drain)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Word Count Estimation: 10,180
Issuing agency(ies): State Drug Administration

YY/T 1760-2021: (Use an abdominal muscle drain)

---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.
(Use an abdominal muscle drain) ICS 11.040 C45 People's Republic of China Pharmaceutical Industry Standard Disposable peritoneal dialysis drain Published on 2021-09-06 2023-03-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Structural 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 content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute. The main drafters of this standard. Xu Suhua, Yan Lin, Ye Xiaoyan, Liang Zexin. Disposable peritoneal dialysis drain

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 article pieces. 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. ......

Image     

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