YY/T 0286.4-2020 PDF English
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| YY/T 0286.4-2020 | English | 260 |
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Special infusion sets - Part 4: Infusion sets for single use with pressure infusion apparatus
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| YY 0286.4-2006 | English | 150 |
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Special infusion sets - Part 4: Single-use infusion equipment for use with pressure infusion apparatus
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YY/T 0286.4-2020: Special infusion sets - Part 4: Infusion sets for single use with pressure infusion apparatus
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0286.4-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
C 31
Replacing YY 0286.4-2006
Special infusion sets - Part 4.Infusion sets for single use with
pressure infusion apparatus
(ISO 8536-8.2015, Infusion equipment for medical use - Part 8.Infusion sets for
single use with pressure infusion apparatus, MOD)
Issued on. JUNE 30, 2020
Implemented on. JUNE 01, 2021
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 General requirements... 7
5 Materials... 11
6 Physical requirements... 11
7 Chemical requirements... 13
8 Biological requirements... 13
9 Packaging... 13
10 Labels... 13
11 Disposal... 14
Appendix A (Normative) Physical test... 16
Appendix B (Normative) Storage volume... 17
Appendix C (Informative) Technical differences between this Part and ISO 8536-
8.2015 and reasons... 20
References... 22
Foreword
The “Special infusion sets” standard series is composed of the following parts.
- YY 0286.1 Special infusion sets - Part 1.Infusion sets with precision filters for
single use
- YY 0286.2 Fluid lines for use with pressure infusion equipment and accessories for
single use - Part 1.Fluid lines
- YY 0286.3 Special infusion sets - Part 3.Light-resistant infusion sets for single use
- YY/T 0286.4 Special infusion sets - Part 4.Infusion sets for single use with
pressure infusion apparatus
- YY/T 0286.5 Special infusion sets - Part 5.Bottle-type and bag-type infusion sets
for single use
- YY/T 0286.6 Special infusion sets - Part 6.Infusion sets for single use with
graduated flow regulator
This Part is Part 4 of YY/T 0286.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY/T 0286.4-2006.Compared with YY/T 0286.4-2006, the main
changes in this Part are as follows.
- CHANGE the nature of the standard, from mandatory to recommended;
- MODIFY the degree of standard adoption, "IDT" (identical adoption) to "MOD"
(modified adoption);
- UPDATE the normative references (see Chapter 2; Chapter 2 of the 2006 edition);
- ADD Chapter 3 Terms and definitions (see Chapter 3);
- DELETE the original Chapter 4 Marking (Chapter 4 of the 2006 edition);
- MODIFY the pipeline requirements, which identically adopt the pipeline length
requirements of ISO 8536-8 (see 6.11; 6.11 of the 2006 edition);
- MODIFY the storage volume requirements; ADD the Appendix B. Test method for
storage volume (see 6.14; 6.14 of the 2006 edition);
- MODIFY the Chapter 10 Requirements for labeling (see Chapter 10; Chapter 10
of the 2006 edition);
- ADD the Chapter 11 Disposal requirements (see Chapter 11);
- DELETE the test method A.4 of the original Appendix A (see A.4 of the 2006
edition);
- MODIFY A.3 Leakage test method (see A.3; A.3 of the 2006 edition).
- UPDATE references.
This Part uses the redrafting method, to modifies and adopts ISO 8536-8.2015 "Infusion
equipment for medical use - Part 8.Infusion sets for single use with pressure infusion
apparatus".
There are technical differences between this Part and ISO 8536-8.2015.Appendix C is
added after Appendix A and Appendix B, giving a list of corresponding technical
differences and their causes.
This Part has also made the following editorial changes.
- ADD the informative Appendix C, giving a list of the corresponding technical
differences and their reasons compared with ISO 8536-8.2015.
Please note that some content in this document may be subject to patents. The publisher
of this document assumes no responsibility for identifying these patents.
This Part was proposed by the National Medical Products Administration.
This Part shall be under the jurisdiction of the National Medical Infusion Equipment
Standardization Technical Committee (SAC/TC 106).
Drafting organizations of this Part. Shandong Provincial Medical Device Product
Quality Inspection Center, Terumo Medical Products (Hangzhou) Co., Ltd., Wuhan
Zhixun Chuangyuan Technology Development Co., Ltd., Jiangsu Yakai Medical
Technology Co., Ltd., Shandong Xinhua Ande Medical Supplies Ltd.
The main drafters of this Part. Yao Xiujun, Wu Liqun, Liu Weijun, Wu Qiyu, Zhang
Xianshun, Li Kanyuan.
This standard replaces the standard previously issued as follows.
- YY 0286.4-2006.
1 Scope
This Part of the "Specialized infusion sets" series of standards specifies the
requirements for sterile supplied disposable infusion sets (hereinafter referred to as
"infusion sets"), for infusion equipment which has a pressure of 200 kPa and below.
This Part applies to disposable infusion sets of infusion equipment, which has a pressure
of 200 kPa and below.
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
3 Terms and definitions
The following terms and definitions apply to this document.
The volume of the pipeline under pressure, which is the sum of the filling volume
(VF) and the bolus volume (VB).
4 General requirements
The infusion set shall have a protective sheath, to keep the inside of the infusion set
sterile before use. The cork piercer or needle of the gas inlet device shall have a
protective sheath.
5 Materials
The materials, which are used in manufacturing the infusion set and its components
given in Chapter 4, shall meet the requirements of Chapter 6.The materials of the
components of the infusion set, that are in contact with the solution, shall also comply
with the requirements specified in Chapters 7 and 8.
6 Physical requirements
When testing according to A.3.2 and A.3.4, there shall be no air or water leakage. When
testing according to A.3.3, no air shall enter.
The injection piece shall be able to inject into the pipeline. When testing according to
A.4, water leakage shall not exceed one drop. The injection piece shall be located at the
accessory of male conical joint.
7 Chemical requirements
GB 8368 is applicable.
8 Biological requirements
GB 8368 is applicable.
9 Packaging
GB 8368 is applicable.
10 Labels
Single packaging shall have at least the following information.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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