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YY 0286.1-2019

Chinese Standard: 'YY 0286.1-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0286.1-2019English209 Add to Cart Days<=3 Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters Valid YY 0286.1-2019
YY 0286.1-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
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 10,156
Date of Issue 2019-05-31
Date of Implementation 2020-12-01
Drafting Organization 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 Weigao Group Medical Polymer Products Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC 106)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

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
Related standard:   YY/T 0286.6-2020
Related PDF sample:   YY 0286.3-2017  YY/T 0282-2009
   
 
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