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YY/T 0487-2010

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YY/T 0487-2010 英文版 530 购买 现货,9秒内自动发货PDF,有增值税发票。 一次性使用无菌脑积水分流器及其组件 有效

   
标准编号: YY/T 0487-2010 (YY/T0487-2010)
中文名称: 一次性使用无菌脑积水分流器及其组件
英文名称: Sterile, single-use hydrocephalus shunts and components
行业: 医药行业标准 (推荐)
中标分类: C48
国际标准分类: 11.040.40
字数估计: 11,121
发布日期: 2010-12-27
实施日期: 2012-06-01
旧标准 (被替代): YY 0487-2004
引用标准: YY 0334; YY/T 0640-2008; ASTM F2503-2005
采用标准: ISO 7197-2006, MOD
起草单位: 山东省医疗器械产品质量检验中心
归口单位: 国家食品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: 国家食品药品监督管理局公告2010年第97号
发布机构: 国家食品药品监督管理局
范围: 本标准规定了一次性使用无菌脑积水分流器及其组件的安全性和性能要求。包括分流器所用的组件, 如阀、管路和储液器。本标准为生产规定了机械和技术要求, 并给出了制造商提供的阀的技术信息。制造商需根据各类阀的工作原理, 给出各类阀的专用特性。本标准不适用于治疗脑积水的有源植入器械。

YY/T 0487-2010
Sterile, single-use hydrocephalus shunts and components
ICS 11.040.40
C48
中华人民共和国医药行业标准
代替YY0487-2004
一次性使用无菌脑积水分流器及其组件
(ISO 7197:2006Neurosurgicalimplants-Sterile,
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YY0487-2004《一次性使用无菌脑积水分流器及其组件》。
本标准与YY0487-2004无论在技术内容上还是在编辑方面均有较大差异。
本标准修改采用ISO 7197:2006《神经外科植入物 一次性使用无菌脑积水分流器及其组件》,与
被采用的国际标准的差异见附录NA。
本标准由国家食品药品监督管理局济南医疗器械质量监督检验中心归口。
本标准主要起草单位:山东省医疗器械产品质量检验中心。
本标准主要起草人:吴平、王金红、宋金子。
引 言
分流器被定义为体内两腔室间的人工连接。对于脑积水的治疗,早期多采用脑室-心房分流器来控
制病人脑室内的压力,现在则更多的是植入脑室-腹腔分流器。在特殊情况下,植入腰-腹腔分流器。脑
积水分流器一般都含有一个用以调节病人脑室压力和控制系统流量的阀。
目前,市售的阀有以下几种型式:
a) 传统的压差阀(differential-pressurevalves,DP-valves)设计成锥形腔中球阀(bal-incone
valves)、隔膜阀(membranevalves)或有机硅裂隙阀(siliconeslitvalves)
这些阀都有一个特定开启压力。如果进口和出口的压差超过该开启压力,则系统打开。开启
后,不同型式压差阀的流量特性差别范围较大。因病人体位改变所产生的差异预期不会对装
置功能带来影响。
b) 与传统压差阀作用相同的可调节压差阀(adjustableDP-valves)
与不可调节装置相比,可调节阀可以在植入后采用体外方式重新调节开启特性。这些装置不
用考虑病人体位变化产生的影响。
c) 为病人体位改变产生的物理变化而专门设计的重力阀(gravitationvalves)或静压装置(hydro-
staticdevices)
这类装置用于避免病人在站立体位时产生不符合生理规律的心室内负压,这种负压可能是带
(或不带)可调节DP-阀分流器内的静压引起的。目前有三种不同的市售静压装置:流量降低
装置(flow-reducingdevices)、带称之为“防虹吸装置(anti-siphon-devices)”或“虹吸控制装置
(siphon-controldevices)”的阀和重力辅助装置(gravity-assisteddevices)。
d) 其他可调节阀,如:
---重力阀:静压装置可调节,还可在体外重新调节其开启性能(第4组);
---可调节防虹吸装置阀(adjustableanti-siphon-devicesvalves);
---可调节流量降低阀(adjustableflow-reducingvalves)。
尽管这些装置的技术和表观性能有很大差异,但仍然没有哪种设计被科学证明更为优良。因为存
在重大的技术差异,必需对不同的阀采用不同的试验程序进行研究。
一次性使用无菌脑积水分流器及其组件
1 范围
本标准规定了一次性使用无菌脑积水分流器及其组件的安全性和性能要求。包括分流器所用的组
件,如阀、管路和储液器。
本标准不给出哪种阀更优越的建议。
本标准为生产规定了机械和技术要求,并给出了制造商提供的阀的技术信息。制造商需根据各类
阀的工作原理,给出各类阀的专用特性。
本标准带给医生和病人的好处在于,可根据本标准理解制造商所提供的信息,从而获取具有设计创
新产品的有关正常使用性能的标准化的信息。本标准带给制造商的好处在于,使他们明确分流器在开
发研究和生产质量控制中的基本的重要要求。
本标准不适用于治疗脑积水的有源植入器械。
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。
YY0334 硅橡胶外科植入物通用要求
YY/T 0640-2008 无源外科植入器械 通用要求(ISO 14630:2005,IDT)
ASTMF2503-05 磁共振环境中医疗器械和其他项目安全性标志的规范
3 术语和定义
下列术语和定义适用于本文件。
3.1
随附文件 accompanyingdocuments
医疗器械或辅助装置附带的文件,包含为器械的使用者、操作者、安装或装配者提供的重要信息,尤
其是制造商提供的安全性方面的信息。
注:出自ISO 14971:2000。
3.2
脑积水 hydrocephalus
头部脑室系统中由于分泌、流动或吸收紊乱引起的过分聚集的脑脊髓液(CSF)状态。
3.3
脑积水分流器 hydrocephalusshunt
典型的是由一根进液管路、一个压力控制装置和一根预期用于调节脑脊髓液(CSF)压力的出液管
路组成的一次性使用器械。
3.4
使用说明书 instructionforuse
由制造商提供的随附文件中的一部分,提供必要的安全和正确使用的信息。

YY/T 0487-2010
                                      Page 1 of 14 
YY
ICS 11.040.40
C 48
Pharmaceutical Industry Standard
of the People’s Republic of China
Replacing YY/T 0487-2004
Sterile, single-use hydrocephalus shunts and
components
一次性使用无菌脑积水分流器及其组件
(ISO 7197.2006 Neurosurgical implants - Sterile,
single-use hydrocephalus shunts and components, MOD)
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
                                      Page 2 of 14 
Table of Contents
Foreword ... 3 
Introduction ... 4 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and Definitions ... 7 
4 General requirements for shunts ... 8 
5 Specific requirements for components ... 10 
6 Marking and labelling of shunts... 11 
7 Packaging ... 11 
8 Information supplied by the manufacturer ... 11 
Appendix NA ... 13 
Bibliography ... 14 
                                      Page 3 of 14 
Foreword
This Standard was drafted in accordance with rules given in GB/T 1.1-2009.
This Standard replaces YY 0487-2004 “Sterile, single-use hydrocephalus shunts and
components”.
Compared with YY 0487 2004, there are significant differences in terms of the technical
contents and editorial aspect.
This Standard modifies and adopts ISO 7197.2006 "Neurosurgical implants - Sterile,
single-use hydrocephalus shunts and components". The differences with the adopted
international standard are listed in Appendix NA.
This Standard shall be under the jurisdiction of Jinan Medical Device Quality
Supervision and Inspection Center of China Food and Drug Administration.
Drafting organization of this Standard. Shandong Medical Devices Product Quality
Inspection Center.
The main drafters of this Standard. Wu Ping, Wang Jinhong and Song Jinzi.
                                      Page 4 of 14 
Introduction
A shunt is defined as an artificial connection of two compartments inside the body. For the
treatment of hydrocephalus, the ventriculo-atrial shunt has been introduced initially to
control the intraventricular pressure in the brain of the patients. Today ventriculo-peritoneal
shunts are preferably implanted. In special cases, a Jumbo-peritoneal shunt is implanted.
Normally a hydrocephalus shunt includes a valve which determines the resulting
intraventricular pressure in the brain of the patients and influences the flow rate through
the shunt.
The following types of valve are currently commercially available.
a) Conventional differential-pressure valves (DP-valves) are designed as ball-in-cone
valves, membrane valves or silicone slit valves.
They have one characteristic opening pressure. If the difference pressure between
inlet and outlet exceeds this opening pressure the device opens. After opening, the
different types of DP-valve show a wide range of different flow characteristics.
Differences due to a changed posture of the patient have no intended impact on the
function of the devices.
b) Adjustable DP-valves act like conventional DP-valves.
In contrast to non-adjustable devices they introduce the possibility of a non-invasive
readjustment of the opening characteristic after implantation. They do not take into
account changes due to a changed posture of the patient.
c) Gravitation valves or hydrostatic devices take into account the changed physics in
a shunt due to a changed posture of the patient.
These devices aim to avoid an unphysiological negative intraventricular pressure in
the upright position of the patient, which might be the consequence of the
are three different hydrostatic devices commercially available. flow-reducing
devices, valves with a so-called "anti-siphon-device" or "siphon-control-device" and
gravity-assisted devices.
d) Other adjustable valves, e.g..
- gravitation valves. adjustable hydrostatic devices present in addition to the
characteristics of hydrostatic devices (group 4) with the possibility of a non-
invasive readjustment of the opening performance of the device;
- adjustable anti-siphon-device valves;
- adjustable flow-reducing valves.
Sterile, single-use hydrocephalus shunts and
components
1 Scope
This Standard specifies safety and performance requirements for sterile, single-use
non-active hydrocephalus shunts and components. This includes the components
used in shunts, like valves, tubes and reservoirs.
This Standard gives no recommendation concerning the superiority of a certain type
of valve.
For manufacturing, it defines the mechanical and technical requirements. This
In respect to the different principles of the valve types, specific characteristics are
defined for each group as declared by the manufacturer.
The benefit of this Standard for the surgeon and the patient is to understand the
information given by the manufacturer and to obtain standardized information about
the performance of a well working product with new design characteristics. The benefit
for the manufacturer is to define the important requirements for shunts as a basis for
investigations during development as well as for quality control during manufacture.
This Standard does not apply to active implants for the treatment of hydrocephalus.
2 Normative references
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this Standard.
YY 0334 General specification for surgical implants made of silicone elastomer
YY/T 0640-2008 Non-active surgical implants-General requirements (ISO
14630.2005, IDT)
ASTM F 2503-05 Standard Practice for Marking Medical Devices and Other Items
for Safety in the Magnetic Resonance Environment
                                      Page 7 of 14 
For the purposes of this document, the following terms and definitions apply.
3.1
accompanying documents
Document accompanying a medical device, or an accessory, and containing important
information for the user, operator, installer or assembler of the medical device,
particularly regarding safety supplied by the manufacturer.
NOTE. Adapted from ISO 14971.2000.
3.2
hydrocephalus
of the head due to a disturbance of secretion, flow or absorption.
3.3
hydrocephalus shunt
Single-use device(s) typically consisting of an inflow catheter, a pressure-controlling
device, and an outflow catheter intended to regulate the pressure of cerebro-spinal
fluid CSF.
3.4
instructions for use
Parts of accompanying documents provided by the manufacturer, giving the necessary
3.5
lumbo-peritoneal drainage
Drainage of cerebro-spinal fluid CSF from the lumbar sub-arachnoid spaces into the
peritoneum.
3.6
patient identification card
Card identifying its holder and issuer, which carries data on the hydrocephalus shunt
                                      Page 9 of 14 
and the accompanying documents.
assembled shunt
The pressure-flow characteristics of the valve shall be tested and monitored in the
relevant flow range of (5 to 50) ml/h. A graph showing the pressure/flow characteristics
shall be included in the accompanying documents.
The manufacturer shall state if the complete system (catheter, reservoir and other
devices) causes fundamental changes in the pressure/flow characteristics. In this case,
graphs showing the pressure/flow characteristics of the complete shunt and the
components shall be included.
NOTE. Fundamental change would be additional resistance due to an inner diameter of the
If the device shows a posture-dependent function, the basic characteristic for the most
important positions should be shown (see 5.1.3).
If the characteristic of the device depends on the subcutaneous pressure, the effects
on the valve performance should be shown in the relevant ranges [see 8.2 g)].
4. 7 Identification of shunts in vivo
The type of the valve as well as the direction of flow shall be detectable non-invasively.
A method for the identification of the valve shall be given In the instructions for use and
In the patient identification card. For adjustable devices, an X-ray image related to the
basic understanding of the pressure settings shall be included in this information.
   
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