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YY 1028-2008

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YY 1028-2008 英文版 430 购买 现货,9秒内自动发货PDF,有增值税发票。 纤维上消化道内窥镜 有效

   
标准编号: YY 1028-2008 (YY1028-2008)
中文名称: 纤维上消化道内窥镜
英文名称: Upper gastro intestinal fiberscope
行业: 医药行业标准
中标分类: C40
国际标准分类: 11.040
字数估计: 13,120
发布日期: 2008-10-17
实施日期: 2010-06-01
旧标准 (被替代): YY 91028-1999
引用标准: GB/T 191-2008; GB 9706.1-2007; GB 9706.19-2000; GB/T 16886.5-2003; GB/T 16886.10-2005; GB/T 14233.1-1998; GB/T 14710-1993
起草单位: 国家药品监督管理局杭州医疗器械质量监督检验中心
归口单位: 全国光学和光学仪器标准化技术委员会医用光学和仪器分技术委员会(SAC/TC 103/SC 1)
标准依据: 国食药监械[2008]605号
提出机构: 全国光学和光学仪器标准化技术委员会医用光学和仪器分技术委员会(SAC/TC 103/SC 1)
发布机构: 国家食品药品监督管理局
范围: 本标准规定了纤维上消化道内窥镜的分类、基本参数、技术要求、试验方法、检验规则、标志、包装、运输和贮存的要求。本标准适用于纤维上消化道内窥镜系列产品, 该系列产品供食道、胃、十二指肠检查、诊断或诊疗用。

YY 1028-2008
Upper gastro intestinal fiberscope
ICS 11.040
C40
中华人民共和国医药行业标准
YY1028-2008
代替YY91028-1999
纤维上消化道内窥镜
2008-10-17发布
2010-06-01实施
国家食品药品监督管理局 发 布
前言
本标准是根据GB 11244-2005《医用内窥镜及附件通用要求》对YY91028-1999《纤维上消化道
镜》进行的修订。
本标准代替YY91028-1999《纤维上消化道镜》。
本标准与YY91028-1999的主要差异为:增加了接触人体部分的生物相容性要求。
本标准的电气安全强制执行 GB 9706.1-2007《医用电气设备 第1部分:通用安全要求》及
GB 9706.19-2000《医用电气设备 第2部分:内窥镜设备安全专用要求》。
本标准的环境试验执行GB/T 14710-1993《医用电气设备环境要求和试验方法》。
本标准的附录A为规范性附录。
本标准 由 全 国 光 学 和 光 学 仪 器 标 准 化 技 术 委 员 会 医 用 光 学 和 仪 器 分 技 术 委 员 会
(SAC/TC103/SC1)提出并归口。
本标准由国家药品监督管理局杭州医疗器械质量监督检验中心负责起草。
本部分主要起草人:毛欣欣、何涛、颜青来、贾晓航、马骏。
YY1028-2008
纤维上消化道内窥镜
1 范围
本标准规定了纤维上消化道内窥镜的分类、基本参数、技术要求、试验方法、检验规则、标志、包装、
运输和贮存的要求。
本标准适用于纤维上消化道内窥镜系列产品,该系列产品供食道、胃、十二指肠检查、诊断或诊
疗用。
2 规范性引用文件
下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有
的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究
是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。
GB/T 191-2008 包装储运图示标志(ISO 780:1997,MOD)
GB 9706.1-2007 医用电气设备 第1部分:通用安全要求(IEC 60601-1:1988,IDT)
GB 9706.19-2000 医用电气设备 第2部分:内窥镜设备安全专用要求(idt IEC 60601-2-18:
1996)
GB/T 16886.5-2003 医疗器械生物学评价 第5部分:体外细胞毒性试验(ISO 10993-5:1999,
IDT)
GB/T 16886.10-2005 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验
(ISO 10993-10:2002,IDT)
GB/T 14233.1-1998  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 14710-1993 医用电气设备环境要求及试验方法
3 产品分类
3.1 纤维上消化道内窥镜型式为前视型、斜视型和侧视型三种。
3.2 纤维上消化道内窥镜主要参数及外形尺寸应符合表1规定。
表1
项 目 参 数
工作长度/mm 600~1300
头端、硬部外径a/mm ≤11
主软管外径a/mm ≤11
钳道孔径/mm ≥2
最大插入部外径/mm ≤11
弯角/(°) 上:≥150;下、左、右:≥90
视场角/(°) ≥80
a双钳孔、大钳孔等特殊用途的纤维上消化道内窥镜其头端硬部外径、主软管外径应不大于14mm。
YY1028-2008

YY 1028-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 40
YYY 1028-2008
Replacing YY 91028-1999
Upper gastro intestinal fiberscope
纤维上消化道内窥镜
Issued by. China Food and Drug Administration
ISSUED ON. OCTOBER 17, 2008
IMPLEMENTED ON. JUNE 01, 2010
Table of Contents
Foreword ... 3 
Upper Gastro Intestinal Fiberscope ... 4 
1  Scope ... 4 
2  Normative References ... 4 
3  Product classification ... 5 
4  Requirements ... 5 
5  Test methods ... 10 
6  Inspection rules ... 17 
7  Labels, marks and operation instructions ... 19 
8  Packaging, transportation and storage ... 20 
Foreword 
This Standard is the revision of YY 91028-1999 “Upper gastro intestinal fiberscope”
according to GB 11244-2005 “General requirements for the medical endoscope and
endoscope accessories”.
This Standard replaces YY 91028-1999 “Upper gastro intestinal fiberscope”.
The main difference between this Standard and YY 91028-1999 is. it adds the
requirements of biological compatibility of touching body parts.
The electrical safety test of this Standard mandatorily executes GB 9706.1-2007 “Medical
electrical equipment - Part 1. General requirements for safety” and GB 9706.19-2000
“Medical electrical equipment - Part 2. Particular requirements for the safety of
endoscopic equipment”.
The environmental test of this Standard excites GB/T 14710-1993 “The environmental
requirements and test methods for medical electrical equipment”.
The Appendix A of this Standard is normative.
This Standard was proposed by and shall be under the jurisdiction of National Technical
Committee on Optics and Optical Instruments Standardization Administration
Subcommittee on Medical Optics and Instrument (SAC/TC 103/SC 1).
This Standard is drafted by Hangzhou Medical Equipment Quality Supervision &
Inspection Centre of State Drug Administration.
Main drafters of this Standard. Mao Xinxin, He Tao, Yan Qinglai, Jia Xiaohang, and Ma
Jun.
Upper Gastro Intestinal Fiberscope
1  Scope 
This Standard specifies upper gastro intestinal fiberscope’s classification, basic
parameters, technical requirements, test method, inspection rules, marking, packaging,
transportation and storage requirements.
This Standard applies to upper gastro intestinal fiberscope series products, which are
used for diagnosis or treatment of oesophagus, stomach and duodenum.
2  Normative References 
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments (excluding
corrections) or revisions do not apply to this Standard, 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 191-2008 Packaging - Pictorial marking for handling of goods
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for
safety
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for
the safety of endoscopic equipment
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test for in vitro
cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Tests for
irritation and delayed-type hypersensitivity
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use - Part
1. Chemical analysis methods
electrical equipment
4.3 Water and air carrying system
4.3.1 Water and air carrying shall be unobstructed; objective lens window surface shall be
able to be washed during water carrying; water carrying volume shall not be less than 40
mL/min; air carrying amount shall not be less than 800 mL/min.
4.3.2 Water and air carrying buttons shall be tilted freely without jamming.
4.3.3 Junctions of water and air carrying system shall match properly, be well-sealed and
have no leak phenomenon.
4.4 Suction and forceps channel system
human body. During imbibition operation, there shall be no fluid back-spray phenomenon
at blowout preventer and suction button.
4.4.2 Suction volume must not be less than 400 mL/min.
4.4.3 Suction button shall be tilted freely without jamming.
4.5 Bending-angle operating system
4.5.1 During corner handwheel is in operation, it shall be handy and flexible, and have no
intermittent-tightness or intermittent-looseness or jamming phenomenon.
4.5.2 Bending-angle locking mechanism shall be able to lock the handwheel; Unlocking of
fixed bending-angle does not affect the operation function of bending-angle handwheel.
snare, etc. can smoothly enter and exit from forceps channel of head-end.
4.5.4 Limit deviation of bending-angle dimension is — 10% (excluding upper limit).
4.6 Sealing performance
4.6.1 Upper gastro intestinal fiberscope is put into water in whole; its inner cavity can
withstand 22 kPa intensity of pressure for 3 min without leakage (applicable to waterproof
type).
4.6.2 Upper gastro intestinal fiberscope is used at a temperature range of 10 °C ~ 40°C.
Surface of optical element shall not have fog layer due to changes of temperature that
may affect observation.
4.7.1 When upper gastro intestinal fiberscope is connected with corresponding accessory
connector, there shall be good matching and free handling, without too tight or too lose
into water, until lens-body is fully immersed in water. Turn the corner handwheel upward
and downward to bend; bend for 3 times in each direction; there shall be no air bubbles
from lens-body within 3 min after stabilization; it shall conform to the requirements of
4.6.1.
Note. Due to the air in external gap, some bubbles may emerge at the beginning of immersion,
which is a normal phenomenon.
5.3.10 Haze test
out; immediately insert into water at 40°C. Observe with eyepiece after taking out; it shall
conform to the provisions of 4.6.2.
5.3.11 Water and air carrying performance test
Water and gas carrying performance test shall be conducted as follows.
a) Turn on the electromagnetic air pump to perform water and air carrying operation;
b) Use measuring cup of which the division value is 5mL and stopwatch to measure
water carrying volume; use air flow meter of which the precision is grade 2.5 to
measure air flow; it shall conform to the provisions of 4.3.1;
c) During water and air carrying test, sealing performance of system junctions shall
d) Repeatedly press-release the water-air button; the mechanical properties shall
conform to the provisions of 4.3.2.
5.3.12 Suction test
Suction test shall be conducted as follows.
a) Immerse the head-end of upper gastro intestinal fiberscope into water; set intensity
of pressure of suction pump to not greater than 70kPa;
b) Use measuring cup of having a division value of 5mL and stopwatch to measure
suction amount; it shall conform to the provisions of 4.4.2;
c) Repeatedly press-release the suction button; its mechanical properties shall
d) During the above operation, there shall be no water sprayed from forceps channel
opening, which shall conform to the provisions of 4.4.1.
5.3.13 Cooperating performance with surgical instruments
Insert the matched biopsy forceps into forceps hole; biopsy forceps shall be within the
view-field of upper gastro intestinal fiberscope, move freely and have no stuck-sluggish
phenomenon, which shall conform to the provisions of 4.7.1 and 4.7.2.
5.4 Use common-use measuring tool or dedicated measuring equipment to measure,
which shall conform to the provisions of 4.9.
5.5 Conduct according to the method specified in GB 9706.1-2007 and GB 9706.19-2000,
5.6 Conduct according to the method specified in GB/T 14710-1993, which shall conform
to the provisions of 4.11.
6  Inspection rules 
6.1 General rules
Upper gastro intestinal fiberscope shall pass the inspection by quality inspection
department of the manufacturer, and be accompanied with product quality inspection
certificate before delivery.
6.2 Group-batch rules
Products of the same-model, produced through one-time material feeding are deemed as
6.3 Inspection classification and inspection items
6.3.1 Inspection is divided into exit-factory inspection and type inspection.
6.3.2 Exit-factory inspection must be carried out when the products are delivered.
6.3.3 Periodical inspection must be carried out under following circumstances.
a) Before new products are launched into...
   
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