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YY 0451-2010

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YY 0451-2010 英文版 810 购买 现货,9秒内自动发货PDF,有增值税发票。 一次性使用便携式输注泵 非电驱动 有效

   
标准详细信息 YY 0451-2010; YY0451-2010
中文名称: 一次性使用便携式输注泵 非电驱动
英文名称: Portable infusion devices for single use - Non electrically driven
行业: 医药行业标准
中标分类: C46
国际标准分类: 11.120.30
字数估计: 14,000
发布日期: 2010-12-27
实施日期: 2012-06-01
旧标准 (被替代): YY 0451-2003
引用标准: GB/T 1962.1; GB/T 1962.2; GB 8368; GB/T 14233.1; GB/T 14233.2; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 1688
起草单位: 山东省医疗器械产品质量检验中心、上海怡新医疗设备有限责任公司
归口单位: 全国输液器具标准化技术委员会(SAC/TC 106)
标准依据: 国家食品药品监督管理局公告2010年第97号
提出机构: 全国输液器具标准化技术委员会(SAC/TC 106)
发布机构: 国家食品药品监督管理局
范围: 本标准规定了非电驱动一次性使用便携式输注泵基本要求和相应的试验方法。适用于可持续给液(固定的或可调节)和(或)自控给液的输注泵。本标准不适用于:IEC 60601-2-24所包括的电驱动或电控制的输液泵;植入式装置;肠给养泵;经皮给液装置;输液动力不是装置自身提供动力, 而是通过患者主动干预来获得动力(如:只靠重力作为动力的装置)。

YY 0451-2010
Portable infusion devices for single use - Non electrically driven
ICS 11.120.30
C46
中华人民共和国医药行业标准
代替YY0451-2003
一次性使用便携式输注泵 非电驱动
Portableinfusiondevicesforsingleuse-Nonelectricalydriven
2010-12-27发布
2012-06-01实施
国家食品药品监督管理局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本标准代替YY0451-2003《一次性使用输注泵》。
本标准中的技术内容参考了ISO/DIS28620:2009《非电驱动便携式输注泵》。
本标准与YY0451-2003主要技术内容差异如下:
---修改了标称容量、标称容量的定义,增加了残留量的定义,取消了有效输注量的定义;
---修改了流量的要求和试验方法;
---修改了自控给液量的要求和试验方法;
---修改了设计和特性的要求和试验;
---修改了化学性能的要求和试验方法。
本标准由全国输液器具标准化技术委员会(SAC/TC106)提出并归口。
本标准起草单位:山东省医疗器械产品质量检验中心、上海怡新医疗设备有限责任公司。
本标准起草人:吴平、姚秀军、沈永、贾彧飞、李克芳。
一次性使用便携式输注泵 非电驱动
1 范围
本标准规定了非电驱动一次性使用便携式输注泵(以下简称输注泵)基本要求和相应的试验方法。
适用于可持续给液(固定的或可调节)和(或)自控给液的输注泵。
本标准不适用于:
---IEC 60601-2-24所包括的电驱动或电控制的输液泵;
---植入式装置;
---肠给养泵;
---经皮给液装置;
---输液动力不是装置自身提供动力,而是通过患者主动干预来获得动力(如:只靠重力作为动力
的装置)。
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/T 1962.1 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 第1部分:通用要求
(GB/T 1962.1-2001,ISO 594-1:1986,IDT)
GB/T 1962.2 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 第2部分:锁定接头
(GB/T 1962.2-2001,ISO 594-2:1998,IDT)
GB 8368 一次性使用输液器 重力输液式(GB 8368-2005,ISO 8536-4:2004,MOD)
GB/T 14233.1 医用输液、输血、注射器具检验方法 第1部分:化学分析方法
GB/T 14233.2 医用输液、输血、注射器具检验方法 第2部分:生物学试验方法
GB/T 16886(所有部分) 医疗器械生物学评价
GB/T 6682 分析实验室用水规格和试验方法(GB/T 6682-2008,ISO 3696:1987,MOD)
YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求
(YY/T 0466.1-2009,ISO 15223-1:2007,IDT)
3 术语和定义
下列术语和定义适用于本文件。
3.1
自控给液 bolus
由患者操作在短时间内输入一定体积的药液。
3.2
自控给液再充装时间 bolusrefiltime
将空的自控给液装置再次充装至自控给液容量所需的时间。

YY 0451-2010
YY
NATIONAL PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.120.30
C 46
Replacing YY 0451-2003
Portable infusion devices for single use –
Non electrically driven
一次性使用便携式输注泵
非电驱动
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 5 
4 General requirements ... 6 
5 Operation requirements ... 10 
6 Test methods ... 10 
7 Information that shall be contained in the package and(or) on the product
... 15 
8 Accompanied documents ... 16 
Appendix A ... 17 
References ... 20 
Foreword
This Standard was drafted according to rules of GB/T 1.1-2009.
This Standard replaces YY 0451-2003 "Single-use injectors for continuous
ambulatory administration of medicinal products by parenteral route".
Technical contents of this Standard references to ISO/DIS 28620.2009
"Portable infusion devices for single use - Non electrically driven".
The main technical differences between this Standard and YY 0451-2003 are.
- Modify nominal capacity and the definition of nominal capacity; add the
definition of residue; delete the definition of effective infusion;
- Modify the requirements and test methods for flow rate; modify the
requirements and test methods for bolus;
- Modify the requirements and tests for design and characteristics;
- Modify the requirements and test methods for chemical performance.
This Standard was proposed by and shall be under the jurisdiction of National
Standardization Technical Committee of Infusion Appliances (SAC/TC 106).
Drafting organizations of this Standard. Shandong Provincial Quality Inspection
Center for Medical Devices and Shanghai Yixin Medical Treatment Equipment
Co., Ltd.
Drafters of this Standard. Wu Ping, Yao Xiujun, Shen Yong, Jia Yufei and Li
Kefang.
Portable infusion devices for single use –
Non electrically driven
1 Scope
This Standard specifies the basic requirements and appropriate test methods
for non electrically driven portable infusion devices (hereinafter referred to as
"infusion device"). It is applicable to sustainable infusion device (fixed or
adjustable) and (or) automatic bolus infusion device.
This Standard is not applicable to.
- Electrically driven or electrically controlled infusion devices included by
IEC 60601-2-24;
- Implantable devices;
- Enteral supply pump;
- Transdermal infusion device;
- Device of which the infusion power is not provided by the device but by
the active intervention of patient (e.g. the device which only takes gravity
as power).
2 Normative references
The following referenced documents are indispensable for the application of
this Standard. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1. General requirement (GB/T 1962.1-
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2. Lock fittings (GB/T 1962.2-2001,
ISO 594-2.1998, IDT);
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-
4.2004, MOD);
GB/T 14233.1 Test methods for infusion transfusion injection equipment for
medical use - Part 1. Chemical analysis methods;
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for
medical use - Part 2. Biological test methods;
GB/T 6682 Water for analytical laboratory use - Specification and test
methods (GB/T 6682-2008,ISO 3696.1987, MOD);
YY/T 0466.1 Medical devices - Symbols to be used with medical device
labels labelling and information to be supplied (YY/T 0466.1-2009, ISO
15223-1.2007, IDT).
3 Terms and definitions
The following terms and definitions are applicable to this Standard.
3.1 Bolus
A certain volume of medicinal liquid infused by the patient in a short time.
The required time of refilling empty bolus device to bolus capacity.
3.3 Nominal bolus refill time
The bolus refill time marked on the infusion device or its package.
3.4 Filling volume
The nominal capacity plus the residual capacity.
3.5 Residual volume
The volume of residual liquid in infusion device as well as in its components.
3.6 Instantaneous flow rate
The ratio between the volume of some infusion and the time required by filling
3.7 Mean flow rate
The ratio between the nominal capacity and the actual time required by infusing
this solution, represented by mL/h.
3.8 Nominal time
The ratio between the nominal capacity and the nominal flow rate.
3.9 Nominal flow rate
The flow rate marked on the infusion device, represented by mL/h.
3.10 Nominal volume
The expected maximum output capacity marked on the infusion device.
The bolus volume marked on the infusion device or its package.
3.12 Portable infusion device
The device that a patience is expected to be infused with medical liquid in
controlled way, and it is expected to be carried by the patient.
3.13 Protective packing
The material structure that is designed to prevent sterile barrier system and its
contents from damage, from assembly to end-use. [ISO 11607-1.2006]
3.14 Sterile barrier system
The minimum package which can prevent the microorganism and make the
4 General requirements
4.1 Composition
The infusion device shall contain the following components.
- Components of supplying power (non battery driven);
- Flow rate-limiting device;
- Reservoir bag for containing the infusion of liquid;
- Liquid medicine filter on the infusion passage of the liquid medicine.
5 Operation requirements
5.1 Accuracy of infusion device
The nominal flow rate of infusion device shall be calibrated by control solution
under given temperature. The nominal flow rate, control solution as well as the
temperature shall be specially specified in the instructions for use that is
accompanied with the infusion device [see 8c and g)].
When doing the test according to 6.2, the mean flow rate shall be within ±15%
deviation range of the nominal flow rate. The adjustable flow rate shall be within
±20% deviation range of the nominal flow rate. The instantaneous flow rate of
at least 80% of nominal flow rate shall be infused within ±50% deviation range
of the nominal flow rate.
When doing the test according to 6.7, the amount of bolus shall not exceed
115% of nominal bolus.
When doing Test 1 according to 6.8, activate the bolus device while refilling the
nominal bolus. The bolus shall be within 50%~115% of nominal bolus.
When doing Test 2 according to 6.8, activate the bolus device while refilling the
nominal bolus till 50%. The bolus shall be less than 75% of nominal bolus.
6 Test methods
6.1 General test conditions
Note. Unless otherwise specified, the following provisions are applicable to all the tests.
6.1.1.1 Control solution
It shall use the control solution recommended by the manufacturer and listed in
the attached documents [see 8.c)].
6.1.1.2 Needle
The specification of needle is specified by the manufacturer. When there is no
specification by the manufacturer, it shall use the needle of which the minimum
inner diameter is 1.2 mm.
After the pressure resistance test of 6.3 and the tensile strength test of 6.6 are
completed, carry out the flow rate determination test under 0 back pressure or
When time t = 0, activate the flow rate.
Note. Reactivate the flow rate after the required stable time recommended by the
manufacturer.
Measure according to the time interval specified in 6.1.3.2 till all the solution in
the infusion device is outputted2).
6.3 Pressure resistance test
Respectively fill the solution of nominal capacity and the dyeing solution of
nominal capacity into the infusion device. Apply 150 N of pressure for 5 s in the
direction perpendicular to the major axis of the infusion device via two suitable
the pressure, respectively carry out the flow rate test of 6.2 and the anti-leak
test of 6.5.
6.4 Dropping test
Fill the dyeing solution of nominal capacity into the infusion device. After the
pressure resistance test of 6.3 and the tensile strength test of 6.6 are completed,
drop it twice f...
   
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