YY/T 0611-2020 English PDF

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YY/T 0611-2020: Parenteral nutrient containers for single use
Status: Valid

YY/T 0611: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0611-2020	259	Add to Cart	3 days	Parenteral nutrient containers for single use	Valid
YY 0611-2007	519	Add to Cart	3 days	Parenteral nutrient containers for single use	Obsolete

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YY 0585.4   YY/T 0614   YY/T 0586   YY/T 0612   

Basic data

Standard ID: YY/T 0611-2020 (YY/T0611-2020)
Description (Translated English): Parenteral nutrient containers for single use
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.20
Word Count Estimation: 14,169
Date of Issue: 2020-09-27
Date of Implementation: 2021-09-01
Older Standard (superseded by this standard): YY 0611-2007
Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies): State Drug Administration

YY/T 0611-2020: Parenteral nutrient containers for single use

---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 intravenous nutrition infusion bag) ICS 11:040:20 C31 People's Republic of China Pharmaceutical Industry Standard Replace YY 0611-2007 Disposable intravenous nutrition infusion bag 2020-09-27 release 2021-09-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY 0611-2007 "One-time use intravenous nutrition infusion bag", compared with YY 0611-2007, except for editorial corrections The main technical changes of the external change are as follows: ---Modified the "example of intravenous nutrition bag" (see Figure 1, Figure 1 of the:2007 edition); --- Deleted the "schematic diagram of nutrition bag with infusion line" (see 3:1 and Figure 2 in:2007 edition); --- Deleted the "mark" (see Chapter 4 of the:2007 edition); ---Modified "materials" (see Chapter 4, Chapter 5 of the:2007 edition); --- Modified "Particulate Pollution" (see 5:1:1, 6:1:1 of the:2007 edition); ---Modified the "leakage" (see 5:1:2, 6:1:2 of the:2007 edition); ---Modified the "stop liquid clamp" (see 5:1:4, 6:2:2:1 of the:2007 edition); ---Added "intake device" (see 5:2:2); ---Modified the "capacity scale" (see 5:3:2, 6:3:2 of the:2007 edition); ---Modified "hanging and falling" (see 5:3:3, 6:3:3 of the:2007 edition); ---Modified the "anti-reopening shutoff device" (see 5:3:4, 6:2:2:2 of the:2007 edition); ---Modified the "injection parts" (see 5:3:6, 6:3:4 of the:2007 edition); --- Deleted "alcohol extractables" (see 7:7 of the:2007 edition); --- Revised the "sign" (see Chapter 8, Chapter 9 of the:2007 edition); ---Modified "Packaging" (see Chapter 9, Chapter 10 of the:2007 edition); --- Added "Disposal" (see Chapter 10); --- Added "Design and Material Guide" (see Appendix A); --- Modified the "Particulate Pollution Test Method" (see Appendix B, Appendix A of the:2007 edition): Please note that certain 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 Infusion Devices (SAC/TC106): Drafting organizations of this standard: Shandong Weigao Group Medical Polymer Products Co:, Ltd:, Shandong Medical Device Product Quality Inspection Xin, Jiangsu Kangjin Medical Equipment Co:, Ltd:, Wuhan Zhixun Chuangyuan Technology Development Co:, Ltd:, Shanghai Caoyang Medical Supplies Factory, Dalian JMS Medical Appliance Co:, Ltd:, Suzhou Baxter Medical Products Co:, Ltd: The main drafters of this standard: Gao Na, Liu Xinglin, Zhang Yilei, Qin Yang, Wu Qiyu, Guo Wei, Sun Xingmei, Zhang Xiang, Zhao Penghai, Li Xingfa: The previous versions of the standard replaced by this standard are as follows: ---YY 0611-2007:

Introduction

Parenteral nutrition (also known as intravenous nutrition) refers to patients who cannot be ingested through the gastrointestinal tract or cannot meet their own metabolic needs by taking in nutrients: The provider provides water, amino acids, fat milk, carbohydrates, electrolytes, vitamins and trace elements: The disposable intravenous nutrition infusion bag is a medical device used for parenteral nutrition therapy: In the intravenous drug compounding center of a medical institution, The intravenous nutrition bag is used for the preparation of parenteral nutrition solution: After storage, transportation, etc:, connect with infusion sets and intravenous devices (such as central venous catheters): The tube) is connected to form an infusion pathway, thereby completing the intravenous infusion of parenteral nutrition to the patient: The time required for parenteral nutrition infusion is often longer Long, it should be used within 24 hours after adding the intravenous nutrition bag: After the disposable intravenous nutrition infusion bag connected with the infusion line is used in the intravenous drug compounding center, the infusion line part is There is the possibility of microbes, pyrogens, particles, etc:, in the links of storage and transportation, and the operation is inconvenient: Therefore, this standard cancels this structure The form of disposable intravenous nutrition infusion bag: Polyvinyl chloride materials are not suitable for storing parenteral nutrition solutions containing fat emulsion: See Appendix A for design and material guidelines: The relevant content of Appendix D in GB 8368-2018 is applicable to this standard: Disposable intravenous nutrition infusion bag

1 Scope

This standard specifies the requirements for sterile supplied disposable intravenous nutrition infusion bags ("intravenous nutrition bags"): This standard applies to disposable intravenous nutrition bags used in conjunction with intravenous infusion devices:

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 references, the latest version (including all amendments) applies to this document: GB/T 6682 Analytical laboratory water specifications and test methods GB 8368-2018 Gravity infusion type disposable infusion set GB/T 14233:1 Medical infusion, blood transfusion, and injection equipment inspection methods Part 1: Chemical analysis methods GB 15811 Sterile injection needle for single use YY/T 0466:1 Medical devices are used for medical device labeling, marking and information symbols: Part 1: General requirements

3 General requirements

3:1 Figure 1 shows an example of the basic structure of an intravenous nutrition bag: As long as the same effect can be achieved, other structural types can also be used: 3:2 The cork puncture of the intravenous nutrition bag should have a protective cover to keep its inside sterile before use: ......

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