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YY/T 0286.5-2021: Special infusion sets - Part 5: Bottle-type and bag-type infusion sets for single use
Status: Valid YY/T 0286.5: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0286.5-2021 | English | 169 |
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Special infusion sets - Part 5: Bottle-type and bag-type infusion sets for single use
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YY/T 0286.5-2021
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| YY 0286.5-2008 | English | 359 |
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Special infusion sets. Part 5: Bottle-type and bag-type infusion sets for single use
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YY 0286.5-2008
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Basic data | Standard ID | YY/T 0286.5-2021 (YY/T0286.5-2021) | | Description (Translated English) | Special infusion sets - Part 5: Bottle-type and bag-type infusion sets for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Word Count Estimation | 9,923 | | Issuing agency(ies) | State Drug Administration | YY/T 0286.5-2021: Special infusion sets - Part 5: Bottle-type and bag-type infusion sets 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.
Special infusion sets - Part 5.Bottle-type and bag-type infusion sets for single use
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standards
Replace YY 0286.5-2008
Dedicated infusion set
Part 5.Disposable bottle type and bag type infusion set
Released on 2021-03-09
2022-04-01 implementation
Issued by the National Medical Products Administration
Foreword
YY/T 0286 "Special Infusion Set" is divided into the following parts.
Part 1.Single-use microporous filter infusion set;
Part 2.Gravity infusion of disposable burette infusion set;
Part 3.One-time use light-proof infusion set;
Part 4.Infusion set for disposable pressure infusion equipment;
Part 5.Disposable bottle type and bag type infusion set;
Part 6.One-time use scaled flow-regulated infusion set.
This part is part 5 of YY/T 0286.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0286.5-2008 "Special Infusion Sets Part 5.Disposable Bottle and Bag Infusion Sets", this part
Compared with YY 0286.5-2008, the main technical changes except for editorial changes are as follows.
---The maximum size of the liquid storage container was increased to 500mL (see Chapter 1, Chapter 1 of the.2008 edition);
---Updated normative reference documents (see Chapter 2, Chapter 2 of the.2008 edition);
--- Deleted the requirement for the pore size of the liquid chemical filter (see footnote d in Figure 1 of the.2008 edition);
--- Modified the leakage (see 6.4, 6.1 of the.2008 edition);
---Modified the requirements of the logo (see Chapter 9, Chapter 9 of the.2008 edition);
---Added disposal requirements (see Chapter 11);
---Added the test method for the tolerance of the liquid bag capacity (see Appendix A);
--- Modified the preparation of the chemical test solution (see Appendix B, Appendix B of the.2008 edition).
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 part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
Drafting organizations of this section. Shandong Weigao Group Medical Polymer Products Co., Ltd., Shandong Medical Device Product Quality Inspection
Xin, Chengdu Xinjinshifeng Medical Equipment Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd.
The main drafters of this section. Li Weiyang, Jia Yufei, Tian Xinglong, Nie Jiaqi, Li Wenchao.
The previous releases of the standards replaced by this part are as follows.
---YY 0286.5-2008.
Introduction
With the continuous development of infusion technology and the increasing clinical requirements, a number of special applications that can adapt to special clinical requirements have appeared one after another.
Infusion set. Since the development of infusion sets is endless, it is expected that all infusion sets with special requirements will be included in a standard.
Impossible, so each part of "Special Infusion Sets" only regulates these special infusion sets for a certain clinical special requirement. Some lose
The infusion set also belongs to a variety of special infusion sets, and the parts applicable to it in the "Special Infusion Set" should be implemented at the same time.
The bottle-type and bag-type infusion sets described in this section are mainly used for the infusion of certain large-volume liquid medicines and the precision of the infusion dosage.
Occasions where the degree of demand is not high.
Appendix D in GB 8368-2018 is applicable to this part.
Dedicated infusion set
Part 5.Disposable bottle type and bag type infusion set
1 Scope
This part of YY/T 0286 stipulates that the liquid storage container is not larger than 500mL, and the disposable bottle is mainly used for liquid infusion.
Type and bag type infusion set (hereinafter referred to as bottle type and bag type infusion set) to ensure that it is compatible with infusion containers and intravenous devices.
This section applies to bottle-type and bag-type infusion sets whose liquid storage container is not larger than 500mL and whose main purpose is to divide liquid infusion.
This section does not apply to burette infusion sets that require precise control of the infusion dose.
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 6682 Analytical laboratory water specifications and test methods
GB 8368 Gravity infusion type disposable infusion set
GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods
GB 15811 Sterile injection needle for single use
3 General requirements
3.1 Typical hanging bottle and bag type infusion set components and their terms are shown in Figure 1.
Note. Figure 1 shows the configuration of a typical bottle/bag infusion set, if it can play the same role, other configurations can also be used.
3.2 Bottle-type and bag-type infusion sets should have a protective cover to keep their interior sterile before use.
3.3 If a separate intake device is used, the intake device should comply with GB 8368.
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