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YY 0286.1-2019

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标准号码内文价格(元)第2步交付天数标准名称状态
YY 0286.1-2019 英文版 1539 购买 有增值税发票,[PDF]天数 <=3 专用输液器 第1部分:一次性使用微孔过滤输液器 有效

   
标准详细信息 YY 0286.1-2019; YY0286.1-2019
中文名称: 专用输液器 第1部分:一次性使用微孔过滤输液器
英文名称: Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters
行业: 医药行业标准
中标分类: C31
国际标准分类: 11.040.20
字数估计: 10,110
发布日期: 2019-05-31
实施日期: 2020-12-01
起草单位: 山东省医疗器械产品质量检验中心、武汉智迅创源科技发展股份有限公司、山东新华安得医疗用品有限公司、北京伏尔特技术有限公司、江西三鑫医疗科技股份有限公司、山东威高集团医用高分子制品股份有限公司
归口单位: 全国医用输液器具标准化技术委员会(SAC/TC 106)
提出机构: 国家药品监督管理局
发布机构: 国家药品监督管理局

YY 0286.1-2019
Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters
ICS 11.040.20
C31
中华人民共和国医药行业标准
代替YY0286.1-2007
专用输液器
第1部分:一次性使用微孔过滤输液器
2019-05-31发布
2020-12-01实施
国家药品监督管理局 发 布
前言
YY0286《专用输液器》,由下列部分组成:
---第1部分:一次性使用微孔过滤输液器;
---第2部分:一次性使用滴定管式输液器,重力输液式;
---第3部分:一次性使用避光输液器;
---第4部分:一次性使用压力输液设备用输液器;
---第5部分:一次性使用吊瓶式和袋式输液器;
---第6部分:一次性使用流量设定微调式输液器。
本部分是YY0286的第1部分。
本部分按照GB/T 1.1-2009给出的规则起草。
本部分代替YY0286.1-2007,与YY0286.1-2007相比,除编辑性修改外主要技术变化如下:
---标准名称由“精密输液器”修改为现名称,且范围扩大到除菌级;
---增加了除菌级药液过滤器的要求;
---增加了标称孔径为1.2μm的药液过滤器的要求;
---增加了排气孔的要求。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本部分由国家药品监督管理局提出。
本部分由全国医用输液器具标准化技术委员会(SAC/TC106)归口。
本部分主要起草单位:山东省医疗器械产品质量检验中心、武汉智迅创源科技发展股份有限公司、
山东新华安得医疗用品有限公司、北京伏尔特技术有限公司、江西三鑫医疗科技股份有限公司、山东威
高集团医用高分子制品股份有限公司。
本标准主要起草人:聂佳琪、吴其玉、李松华、杨建鑫、刘晓红、李未扬、王文庆、郭伟、罗勇、高娜、
王亚琴。
本部分所代替标准的历次版本发布情况为:
---YY0286.1-2007。
引 言
随着输液技术的不断发展和临床要求的日益提高,相继出现了一些能适应于特殊临床要求的输液
器。期望在一项标准中把所有有特殊要求的输液器都包括进来是不可能的。因此,YY0286的各部分
都只针对一个临床特殊要求来规范这些专用输液器。有些专用输液器可能兼属于多种专用输液器,应
同时执行YY0286中与其相适用的部分。
YY0286本部分规定的微孔过滤输液器与普通输液器的差异在于前者带有更高过滤性能的药液
过滤器。包括除菌级药液过滤器和微米级药液过滤器。这些输液器适用于临床不同药物的使用要求和
对输液质量有较高要求的患者。
专用输液器
第1部分:一次性使用微孔过滤输液器
1 范围
YY0286的本部分规定了一次性使用微孔过滤输液器(以下简称输液器)的要求。
本部分适用于带有标称孔径为0.22μm1
)、1.2μm、2.0μm~5.0μm的药液过滤器的输液器。
1) 也有标称为0.2μm的。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB 8368 一次性使用输液器 重力输液式
YY/T 0918 药液过滤膜、药液过滤器细菌截留试验方法
3 术语与定义
下列术语和定义适用于本文件。
3.1
微孔过滤输液器 infusionsetswithmicroporefilters
带有标称孔径为0.22μm、1.2μm、2.0μm~5.0μm的药液过滤器的输液器。
3.2
除菌级药液过滤器 sterilizing-gradefilters
标称孔径不超过0.22μm的药液过滤器。
3.3
微米级药液过滤器 micron-gradefilters
标称孔径为1.2μm、2.0μm~5.0μm的药液过滤器。
4 通用要求
同GB 8368通用要求(药液过滤器孔径除外)的规定。
5 标记示例
5.1 输液器
符合YY0286本部分要求、带标称孔径为0.22μm的药液过滤器的输液器应以描述文字加本部分
编号、字母IS、再加字母F和过滤器标称孔径标记,如下。
输液器 YY0286.1-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
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).
5.1 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
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
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 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 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.
---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.
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.
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.
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
   
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