Search result: YY 0286.1-2019 (YY 0286.1-2007 Older version)
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| YY 0286.1-2019 | English | 199 |
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Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters
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YY 0286.1-2019
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| YY 0286.1-2007 | English | 359 |
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Special infusion sets. Part 1: Infusion sets with precision filters for single use
| Obsolete |
YY 0286.1-2007
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| YY 0286-1996 | English | 519 |
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(Disposable burette type infusion)
| Obsolete |
YY 0286-1996
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| Standard ID | YY 0286.1-2019 (YY0286.1-2019) | | Description (Translated English) | Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,185 | | Date of Issue | 2019 | | Date of Implementation | 2020-12-01 | | Summary | This standard specifies the requirements for single-use microporous filter infusion sets. This standard is applicable to infusion sets with medicinal liquid filters with nominal pore diameters of 0.22 ��m, 1.2 ��m, 2.0 ��m to 5.0 ��m. |
YY 0286.1-2019
Infusion sets for special purpose - Part 1. Infusion sets for single use with micropore filters
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0286.1-2007
Special infusion set
Part 1. Single-use microfiltration infusion set
Infusionsetsforspecialpurpose-
Part 1. Infusionsetsforsingleusewithmicroporefilters
Published on.2019-05-31
2020-12-01 implementation
State Drug Administration issued
Foreword
YY 0286 "Special Infusion Set" consists of the following parts.
--- Part 1. Single-use microfiltration filtration infusion set;
--- Part 2. Single-use burette infusion set, gravity infusion;
--- Part 3. One-time use of light infusion sets;
--- Part 4. Infusion sets for single use pressure infusion equipment;
---Part 5. Disposable bottle and bag infusion sets;
--- Part 6. Single-use flow setting fine-tuning infusion set.
This part is the first part of YY 0286.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0286.1-2007. Compared with YY 0286.1-2007, the main technical changes except editorial changes are as follows.
---The standard name was changed from the "precision infusion set" to the current name, and the scope was expanded to the sterilization level;
--- Increased the requirements for the sterilization grade liquid filter;
--- Increased the requirement of a liquid filter with a nominal pore size of 1.2 μm;
--- Increased venting requirements.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section is mainly drafted by. Shandong Medical Device Product Quality Inspection Center, Wuhan Zhixun Chuangyuan Technology Development Co., Ltd.
Shandong Xinhua Ande Medical Products Co., Ltd., Beijing Volt Technology Co., Ltd., Jiangxi Sanxin Medical Technology Co., Ltd., Shandong Wei
Gao Group Medical Polymer Products Co., Ltd.
The main drafters of this standard. Nie Jiaqi, Wu Qiyu, Li Songhua, Yang Jianxin, Liu Xiaohong, Li Weiyang, Wang Wenqing, Guo Wei, Luo Yong, Gao Na,
Wang Yaqin.
The previous versions of the standards replaced by this section are.
---YY 0286.1-2007.
introduction
With the continuous development of infusion technology and the increasing clinical requirements, there have been some infusions that can be adapted to special clinical requirements.
Device. It is not expected to include all infusion sets with special requirements in one standard. Therefore, the various parts of YY 0286
These dedicated infusion sets are only specified for a specific clinical requirement. Some special infusion sets may belong to a variety of special infusion sets, should
At the same time, the part corresponding to YY 0286 is executed.
The difference between the micro-filtered infusion set specified in this section of YY 0286 and the ordinary infusion set is that the former has a higher filtration performance.
filter. Includes sterilizing grade liquid filter and micron level liquid filter. These infusion sets are suitable for clinical use of different drugs and
Patients with high requirements for infusion quality.
Special infusion set
Part 1. Single-use microfiltration infusion set
1 Scope
This part of YY 0286 specifies the requirements for a single-use microfiltration filter infusion set (hereinafter referred to as an infusion set).
This section applies to a nominal aperture of 0.22μm1
), an infusion set of a 1.2 μm, 2.0 μm to 5.0 μm medical solution filter.
1) Also marked as 0.2μm.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 8368 Disposable Infusion Set Gravity Infusion
YY/T 0918 liquid filtration membrane, liquid filtration filter method for bacterial retention
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Microporous filtration infusion set infusionsetswithmicroporefilters
An infusion set with a medical fluid filter having a nominal pore size of 0.22 μm, 1.2 μm, and 2.0 μm to 5.0 μm.
3.2
Sterilization-grade liquid filter sterilizing-gradefilters
A liquid filter with a nominal pore size of no more than 0.22 μm.
3.3
Micron grade filter micron-gradefilters
A chemical liquid filter having a nominal pore size of 1.2 μm and 2.0 μm to 5.0 μm.
4 General requirements
With the general requirements of GB 8368 (except for the pore size of the liquid filter).
5 tag example
5.1 Infusion set
The infusion set that meets the requirements of this part of YY 0286 and has a nominal liquid crystal filter with a pore size of 0.22 μm shall be described in the text of the text.
The number, the letter IS, plus the letter F and the filter nominal aperture mark are as follows.
Infusion set YY 0286.1-IS-F0.22
YY 0286.1-2019
Infusion sets for special purpose - Part 1. Infusion sets for single use with micropore filters
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0286.1-2007
Special infusion set
Part 1. Single-use microfiltration infusion set
Infusionsetsforspecialpurpose-
Part 1. Infusionsetsforsingleusewithmicroporefilters
Published on.2019-05-31
2020-12-01 implementation
State Drug Administration issued
Foreword
YY 0286 "Special Infusion Set" consists of the following parts.
--- Part 1. Single-use microfiltration filtration infusion set;
--- Part 2. Single-use burette infusion set, gravity infusion;
--- Part 3. One-time use of light infusion sets;
--- Part 4. Infusion sets for single use pressure infusion equipment;
---Part 5. Disposable bottle and bag infusion sets;
--- Part 6. Single-use flow setting fine-tuning infusion set.
This part is the first part of YY 0286.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0286.1-2007. Compared with YY 0286.1-2007, the main technical changes except editorial changes are as follows.
---The standard name was changed from the "precision infusion set" to the current name, and the scope was expanded to the sterilization level;
--- Increased the requirements for the sterilization grade liquid filter;
--- Increased the requirement of a liquid filter with a nominal pore size of 1.2 μm;
--- Increased venting requirements.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section is mainly drafted by. Shandong Medical Device Product Quality Inspection Center, Wuhan Zhixun Chuangyuan Technology Development Co., Ltd.
Shandong Xinhua Ande Medical Products Co., Ltd., Beijing Volt Technology Co., Ltd., Jiangxi Sanxin Medical Technology Co., Ltd., Shandong Wei
Gao Group Medical Polymer Products Co., Ltd.
The main drafters of this standard. Nie Jiaqi, Wu Qiyu, Li Songhua, Yang Jianxin, Liu Xiaohong, Li Weiyang, Wang Wenqing, Guo Wei, Luo Yong, Gao Na,
Wang Yaqin.
The previous versions of the standards replaced by this section are.
---YY 0286.1-2007.
introduction
With the continuous development of infusion technology and the increasing clinical requirements, there have been some infusions that can be adapted to special clinical requirements.
Device. It is not expected to include all infusion sets with special requirements in one standard. Therefore, the various parts of YY 0286
These dedicated infusion sets are only specified for a specific clinical requirement. Some special infusion sets may belong to a variety of special infusion sets, should
At the same time, the part corresponding to YY 0286 is executed.
The difference between the micro-filtered infusion set specified in this section of YY 0286 and the ordinary infusion set is that the former has a higher filtration performance.
filter. Includes sterilizing grade liquid filter and micron level liquid filter. These infusion sets are suitable for clinical use of different drugs and
Patients with high requirements for infusion quality.
Special infusion set
Part 1. Single-use microfiltration infusion set
1 Scope
This part of YY 0286 specifies the requirements for a single-use microfiltration filter infusion set (hereinafter referred to as an infusion set).
This section applies to a nominal aperture of 0.22μm1
), an infusion set of a 1.2 μm, 2.0 μm to 5.0 μm medical solution filter.
1) Also marked as 0.2μm.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 8368 Disposable Infusion Set Gravity Infusion
YY/T 0918 liquid filtration membrane, liquid filtration filter method for bacterial retention
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Microporous filtration infusion set infusionsetswithmicroporefilters
An infusion set with a medical fluid filter having a nominal pore size of 0.22 μm, 1.2 μm, and 2.0 μm to 5.0 μm.
3.2
Sterilization-grade liquid filter sterilizing-gradefilters
A liquid filter with a nominal pore size of no more than 0.22 μm.
3.3
Micron grade filter micron-gradefilters
A chemical liquid filter having a nominal pore size of 1.2 μm and 2.0 μm to 5.0 μm.
4 General requirements
With the general requirements of GB 8368 (except for the pore size of the liquid filter).
5 tag example
5.1 Infusion set
The infusion set that meets the requirements of this part of YY 0286 and has a nominal liquid crystal filter with a pore size of 0.22 μm shall be described in the text of the text.
The number, the letter IS, plus the letter F and the filter nominal aperture mark are as follows.
Infusion set YY 0286.1-IS-F0.22
......
YY 0286.1-2007
Special infusion sets.Part 1. Infusion sets with precision filters for single use
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Special infusion - Part 1.
Single use sophisticated filters infusion
Posted 2007-08-14
2008-04-01 implementation
State Food and Drug Administration issued
Foreword
YY 0286 "Special infusion" includes the following components.
--- Part 1. Single-use sophisticated filters infusion;
--- Part 2. Burette infusion sets for single use gravity infusion formula;
--- Part 3. dark disposable infusion device;
--- Part 4. disposable infusion pressure infusion equipment;
--- Part 5. disposable infusion bag and bottle of formula.
This is Part 1 YY 0286 of.
This section compared with GB 18458.1-2001, the main technical difference is.
--- Increased fluid filter design requirements;
--- Revised test methods for liquid filter efficiency.
This section of the Appendices A and B are normative appendix.
This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) and focal points.
This section drafted by. V Stuart Technology Co., Ltd. Beijing, Wuhan-Xun a source of Science and Technology Development Company Limited.
The main drafters of this section. Guoshi Lun, Zhu double, Rayong, Zhang Guohui.
introduction
With the continuous development of technology infusion and increasing clinical requirements, it has produced some can be adapted to the special requirements of clinical transfusion
Device. Since the development of products is endless, it is desirable in a standard in all the special requirements of the infusion is not possible to include all
of. Thus, each part of YY 0286 only for a specific clinical requirements to regulate these special infusion. Some Special infusion may
Also you can belong to a variety of special infusion should be performed YY 0286 applicable thereto in part simultaneously.
Infusion YY 0286 the provisions of this Part of the liquid in the liquid filter can 2.0μm, 3.0μm or 5.0μm above particles
Filtered. This infusion for special patients with higher requirements for the quality of the infusion.
GB 8368 Appendix NA applies YY 0286 this section.
Special infusion - Part 1.
Single use sophisticated filters infusion
1 Scope
YY 0286 This section specifies the liquid filter medium nominal pore size 1) is 2.0μm ~ 5.0μm disposable precision
Filters infusion (hereinafter referred to as infusion) requirements.
This section applies to single use sophisticated filters infusion.
1) for describing a nominal pore size filter to filter out the particle diameter of the aperture is not the actual filter medium.
2 Normative references
The following documents contain provisions which, through reference YY 0286 present, constitute provisions of this section. For dated references,
All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section
Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
GB 8368 disposable infusion gravity infusion of formula (GB 8368-2005, ISO 8536-4.2004, MOD)
3 General requirements
With GB 8368 regulations.
4 tag example
4.1 Infusion
Comply with the requirements of this YY 0286 filter media pore size of 5.0μm nominal infusion should be descriptive text, add this part number,
Letters IS, precision filter media labeled PF plus nominal pore size.
Infusion YY 0286.1-IS-PF-5.0
4.2 intake device
With GB 8368 regulations.
5 material
Production infusion materials and components shall meet the requirements of Chapter 6. Parts in contact with the solution should be in line with Chapter 7 and Chapter 8
Claim.
6 Physical Requirements
6.1 General
In addition to the physical requirements of infusion should be consistent with 6.2 to 6.3, it should also comply with the requirements of GB 8368 (except for the infusion flow rate).
6.2 liquid filter
6.2.1 Design
Liquid filter structure design should make it easy to exclude outside air infusion process, should be able to observe the internal fluid filter
No bubbles.
6.2.2 particulate pollution
Filter particulate pollution measured in accordance with Appendix A or other equivalent method, 60mL eluent, 5.0μm particles should not exceed more than
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