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YY 0286.4-2006

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YY 0286.4-2006 英文版 580 购买 现货,9秒内自动发货PDF,有增值税发票。 专用输液器 第4部分:一次性使用压力输液设备用输液器 有效

   
标准详细信息 YY 0286.4-2006; YY0286.4-2006
中文名称: 专用输液器 第4部分:一次性使用压力输液设备用输液器
英文名称: Special infusion sets - Part 4: Single-use infusion equipment for use with pressure infusion apparatus
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: 13,000
发布日期: 2006-04-19
实施日期: 2007-04-01
引用标准: GB/T 1962.2; GB 8368; YY 0466; GB 9706.27
采用标准: ISO 8536-8-2004, IDT
起草单位: 山东省医疗器械产品质量检验中心、山东威高集团股份有限公司
归口单位: 国家药品监督管理局济南医疗器械质量监督检验中心
标准依据: 国食药监械[2006]157号
提出机构: 全国医用输液器具标准化技术委员会
发布机构: 国家食品药品监督管理局
范围: YY 0286本部分规定了无菌供应的用于200kPa以下压力的输液设备的一次性使用输液器(以下简称:输液器)的要求。


YY 0286.4-2006
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0286.4-2006 / ISO 8536-8.2004
Special infusion sets - Part 4. Single-use
infusion equipment for use with pressure
infusion apparatus
专用输液器 第 4部分.
一次性使用压力输液设备用输液器
(ISO 8536-8.2004, Infusion equipment for medical use –
Part 8. Infusion equipment for use with pressure infusion apparatus, IDT)
ISSUED ON. APRIL 19, 2006
IMPLEMENTED ON. APRIL 1, 2007
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 4 
1  Scope ... 5 
2  Normative references ... 5 
5  Materials ... 9 
6  Physical requirements ... 9 
7  Chemical requirements ... 10 
Annex A (Normative) Physical tests ... 13 
Annex B (Normative) Chemical tests ... 15 
Annex C (Normative) Biological tests ... 16 
Annex NA (Informative) Test Method for Storage Volume ... 17 
Bibliography ... 19 
Introduction
With the ever developing infusion techniques and increasingly improved clinical
requirements, some dedicated infusion sets applicable to special clinical requirements
have appeared in succession. The YY 0286 standard is specifically devised to standardize
these dedicated infusion sets. As the development of infusion sets is endless, it is
impossible to expect to have every dedicated infusion set having special requirements
covered in one standard alone. Therefore, every part of YY 0286 works for only one
special clinical requirement to standardize these dedicated infusion sets. In case one
infusion set falls into these having various special purposes as well, it shall conform to the
applicable parts in YY 0286.
The storage volume involved in this Part of YY 0286 is an index to investigate the
compliance of an infusion set. When used with pressure infusion equipment, if the infusion
switch (if any) at the end is opened, the infusion set will, because of the action of the
pressure supplied by the infusion equipment, deliver excess liquid to the patient on the
instant the switch is opened. This may have an adverse effect on the patient.
The determination of storage volume shall undergo a test together with the suitable
pressure infusion equipment. This is a job that both infusion set manufacturers and
pressure infusion equipment shall do jointly.
The term “storage volume” in this Part of YY 0286 is “bolus volume” in English in GB
9706.27-2005. Such explanation is helpful to further learn the related contents in GB
9706.27-2005 (see also Annex NA).
The Annex NA in GB 8368 is applicable to this Part of YY0286.
Special infusion sets - Part 4. Single-use infusion equipment
for use with pressure infusion apparatus
1 Scope
This Part of YY 0286 gives users information on sterilized infusion sets for single use with
pressure infusion equipment (hereinafter referred to as infusion set) up to a maximum of
200 kPa.
2 Normative references
The articles contained in the following documents have become part of this Part of YY
0286 when they are quoted herein. For the dated documents so quoted, all the
modifications (excluding corrections) or revisions made thereafter shall not be applicable
to this Part. For the undated documents so quoted, the latest editions shall be applicable
to this Part.
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, idt ISO 594-2.1994)
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, GB 8368-2005, ISO
8536-4.2004, MOD)
YY 0466 Medical devices - Symbols to be used with medical device labels labelling and
information to be supplied (YY 0466-2003, ISO 15223.2000, IDT)
safety of infusion pumps and controllers (GB 9706.27-2005, IEC 60601-2-24.1998, IDT)
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate
air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the
configuration of infusion sets and air-inlet devices; other configurations may be used
provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only
be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in
Figure 1 shall be used for rigid containers.
NA.4 The switch is opened to gather the storage volume generated because of switch
closing before the pressure reduces to atmospheric pressure.
If the equipment instructions offer the methods of eliminating storage volume before the
infusion set is opened, the storage volume shall be first eliminated according to the
methods described in the instructions before the residual storage volume is measured.
Bibliography
[1] ISO 31-3 Quantities and units - Part 3. Mechanics
[2] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
sterilization (idt ISO 11135.1994)
[4] GB 18280-2000 Sterilization of health care products - Requirements for validation
and routine (idt ISO 11137.1995)
[5] GB/T 6682-1992 Water for analytical laboratory use - Specification and test methods
(neq ISO 3696.1997)
[6] YY 0451 Portable infusion devices for single use
[7] Chinese Pharmacopoeia
   
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