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YY 0585.4-2009

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YY 0585.4-2009 英文版 470 购买 现货,9秒内自动发货PDF,有增值税发票。 压力输液设备用一次性使用液路及附件 第4部分:防回流阀 有效

   
标准详细信息 YY 0585.4-2009; YY0585.4-2009
中文名称: 压力输液设备用一次性使用液路及附件 第4部分:防回流阀
英文名称: Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4: Check valves
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: 9,000
发布日期: 2009-12-30
实施日期: 2011-06-01
引用标准: GB/T 1962.2; GB 8368; GB/T 16886.1; YY 0466; ISO 8871-1; ISO 8871-2
采用标准: ISO 8536-12-2007, MOD
起草单位: 山东省医疗器械产品质量检验中心
归口单位: 全国医用输液器具标准化技术委员会
范围: YY 0585.4本部分适用于一次性使用重力输液和/或压力输液式输液器具用无菌防回流阀。


YY 0585.4-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Fluid lines for use with pressure infusion
equipment and accessories for single use -
Part 4. Check valves
压力输液装置用一次性使用液路及其附件
第 4 部分. 防回流阀
(ISO 8536-12.2007 Infusion equipment for medical use
Part 12. Check valves, MOD)
ISSUED ON. DECEMBER 27, 2009
IMPLEMENTED ON. JUNE 01, 2009
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Marks ... 5 
5 Materials ... 5 
6 Physical requirements ... 5 
7 Chemical requirements ... 6 
8 Biological requirements ... 6 
9 Packaging... 7 
10 Labels ... 7 
Annex A ... 9 
Annex NA ... 13 
Foreword
The Part modified and adopted ISO 8536 12.2007 “Infusion equipment for medical use
- Part 12. Check valves”.
The general title of YY 0585 is “Fluid lines for use with pressure infusion equipment
and accessories for single use”, including the following parts.
Part 1. Fluid lines;
Part 2. Accessories;
Part 3. Filters;
Part 4. Check valves.
In this Part, Annex A is normative, Annex NA is informative.
This Part was proposed by China Food and Drug Administration.
This Part shall be under jurisdiction of the China National Standards Technical
Committee of Infusion Equipment for Medical Use (SAC/TC106).
Main drafting organization of this Part. Shandong Quality Supervision and Inspection
Center for Medical Devices.
Main drafters of this Part. Wan Min, Song Jinzi, Yao Xiujun, Wu Ping.
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 4. Check valves
1 Scope
This Part of YY 0585.4 applies to sterile check valves for gravity feed infusion sets
and/or pressure feed infusion sets for single use.
Note. The basic requirements in this Part also applies to the built-in check valves.
2 Normative references
The provisions in following documents become the provisions of this Part of YY 0585
through reference in this Part. For dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Part, however, parties who
reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
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 6886.1 Biological evaluation of medical devices - Part 1. Evaluation and
testing (GB/T 16886.1-2001, ISO 10993-1.1997, IDT)
YY 0466 Medical devices - Symbols to be used with medical device labels labeling
and information to be supplied (YY 0466- 2003, ISO 15223.2000, IDT)
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical
ISO 8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical
use - Part 2. Identification and characterization
3 Terms and definitions
8.1 Sterilization
It shall comply with GB 8368.
8.2 Pyrogen
It shall comply with GB 8368.
8.3 Biological compatibility
When evaluating the biological compatibility of check valves, it shall be performed
9 Packaging
It shall comply with GB 8368.
10 Labels
10.1 Single packages
The single package containers shall indicating the following information.
a) Text description of the contents;
b) The graphic symbols given in YY 0466, indicating that the check valve is sterile;
c) The check valve has no pyrogen or the check valve has no bacterial endotoxin;
d) The check valve is for single use only, or equivalent texts, or graphic symbols
e) Instructions for use, including warnings, such as checking whether the
protective cover is off;
f) The lot number starts with the word "batch (LOT)", or adopts the graphic symbols
given in YY 0466;
g) The words of "Safe for pressure infusion devices"1;
h) The identification marks that comply with Chapter 4 (such as YY 0585.4/ ISO
8536-12-CV-P);
i) The letter "P" that represents the pressure, its size shall be bigger than the
        
At (23 ± 2)°C and (40 ± 2)°C respectively, SUBJECT the check valve to a water
pressure of 200kPa in the counterflow direction for 15min. Check for leakage through
the check valve.
A.6 Volumetric flow rate
CONNECT the check valve with the infusion set, according to the specifications of GB
8368.
NOTE. If the requirements of 6.6 are not met, the infusion sets without the check valve shall be
tested.
A.7 Blocking performance
When performing tests, the check valve shall be performed at least three tests under
the states of horizontal position, vertical position and reverse vertical position.
The check valve shall be connected to the test system shown in Figure A.1.
For the check valve that is permanently installed in the fluid line, the pipe shall be cut
off, a three-way switch with the tube shall be installed. It can also decline the liquid
level of the test solution in the pipe, and make a liquid level mark.
FILL the entire system with the required test solution, avoid air bubbles, and then
perform the following steps.
a) Switch position 1
b) Switch position 2
KEEP the switch of the infusion set pipe on, there shall be a flow through the
check valve for 2min.
c) Switch position 3
It shall observe.
- the pressure of the pump and the check valve pipe indicated on the pressure
gauge is rising;
- the water level in the tube is moving toward the outlet end and the fluid drops
        
Standard, and a footnote 1 is added to
explain this modification
used at 10°C. In addition,
the test temperature in all
other provisions is (23 ±
2)°C
A.7a) ADD a footnote, recommending a feed rate of 0.3mL/h
The technical
requirements of
requires to test at this rate.
After verification, it is
considered that it
necessary to recommend
this feed rate, to help
obtain comparable results
A.8.1 MODIFY (23 ± 3)°C in the international standard TO (23 ± 2)°C
Compared with A.5, adjust
the tolerance of the test
reasonable
   
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