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YY/T 0283-2007

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YY/T 0283-2007 英文版 810 购买 现货,9秒内自动发货PDF,有增值税发票。 纤维大肠内窥镜 有效

   
标准编号: YY/T 0283-2007 (YY/T0283-2007)
中文名称: 纤维大肠内窥镜
英文名称: Large intestine fiber endoscope
行业: 医药行业标准 (推荐)
中标分类: C40
国际标准分类: 11.040.70
字数估计: 19,186
发布日期: 2007-07-02
实施日期: 2008-03-01
旧标准 (被替代): YY/T 0283-1995
引用标准: GB/T 191-2000; GB/T 2829-2002; GB 9706.1-1995; GB 9706.4-1999; GB 9706.19-2000; GB 11244-2005; GB/T 14710-1993; GB/T 16886.1-2001; GB/T 16886.5-2003; GB/T 16886.10-2005; YY 0466-2003; 中华人民共和国药典2005版; 医疗器械说明书\标签和包装标识管理规定(国家食品药品监督管理局第10号令)
起草单位: 上海医疗器械股份有限公司医用光学仪器厂
归口单位: 全国医用光学和仪器标准化分技术委员会
标准依据: 中国行业标准备案公告2007年第9号(总第93号)
提出机构: 全国医用光学和仪器标准化分技术委员会
发布机构: 国家食品药品监督管理局
范围: 本标准规定了纤维大肠内窥镜的分类和标记、要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存。本标准适用于纤维大肠内窥镜(以下简称纤维大肠镜)。该产品用于人体大肠内腔的检查、诊断, 配合相关手术系统可进行治疗。

YY/T 0283-2007
Large intestine fiber endoscope
ICS 11.040.70
C40
中华人民共和国医药行业标准
YY/T0283-2007
代替YY/T 0283-1995
纤 维 大 肠 内 窥 镜
2007-07-02发布
2008-03-01实施
国家食品药品监督管理局 发 布
前言
本标准是对YY/T 0283-1995《纤维大肠镜》的修订。
本标准与YY/T 0283-1995的主要差异:
---对标准名称进行了规范;
---增加了对产品按防水性的分类;
---提高了断丝数指标;
---增加了对照明光源和观察视场的重合要求;
---修改了产品标记要求;
---增加对防水型产品的要求;
---增加生物相容性要求;
---修改了视场角的试验方法;
---取消原标准中密封性能的要求;
---增加了附录A(规范性附录)。
电气连接部分全面贯彻GB 9706.1-1995《医用电气设备 第一部分:安全通用要求》、GB 9706.4-
1999《医用电气设备 第2部分:高频手术设备安全专用要求》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》的要求,具体内容以附录A(规范性附录)形式给出。
本标准的附录A、附录B是规范性附录,附录C是资料性附录。
本标准自实施之日起,代替YY/T 0283-1995。
本标准由国家食品药品监督管理局批准。
本标准由全国医用光学和仪器标准化分技术委员会提出并归口。
本标准起草单位:上海医疗器械股份有限公司医用光学仪器厂。
本标准主要起草人:李雅芬、孙琦、沈天明。
本标准于1995年11月首次发布。
YY/T0283-2007
纤 维 大 肠 内 窥 镜
1 范围
本标准规定了纤维大肠内窥镜的分类和标记、要求、试验方法、检验规则、标志、使用说明书和包装、
运输、贮存。
本标准适用于纤维大肠内窥镜(以下简称纤维大肠镜)。该产品用于人体大肠内腔的检查、诊断,配
合相关手术系统可进行治疗。
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 191-2000 包装储运图示标志
GB/T 2829-2002 周期检验计数抽样程序及表(适用于对过程稳定性的检验)
GB 9706.1-1995 医用电气设备 第一部分:安全通用要求(idt IEC 601-1:1988)
GB 9706.4-1999 医用电气设备 第2部分:高频手术设备安全专用要求(idt IEC 60601-2-2:
1991)
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 11244-2005 医用内窥镜及附件通用要求
GB/T 14710-1993 医用电气设备环境要求及试验方法
GB/T 16886.1-2001 医疗器械生物学评价 第1部分:评价与试验(idt ISO 10993-1:1997)
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)
YY0466-2003 医疗器械 用于医疗器械标签、标记和提供信息的符号(ISO 15223:2000,IDT)
中华人民共和国药典 2005版
医疗器械说明书、标签和包装标识管理规定(国家食品药品监督管理局第10号令)
3 分类
3.1 纤维大肠镜包括乙状结肠镜和结肠镜。
3.2 纤维大肠镜的型式为前视型。
3.3 纤维大肠镜按使用后清洗程度分为:普通型、防水型。
4 要求
4.1 工作条件
纤维大肠镜正常工作条件:
a) 环境温度范围:5℃~40℃;
b) 相对湿度范围:30%~80%;
YY/T0283-2007

YY/T 0283-2007
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Replacing YY/T 0283-1995
Large intestine fiber endoscope
纤维大肠内窥镜
Issued by. China Food and Drug Administration
ISSUED ON. JULY 02, 2007
IMPLEMENTED ON. MARCH 01, 2008
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Classification ... 5 
4  Requirements ... 5 
5  Test methods ... 8 
6  Inspection rules ... 14 
7  Marking and operation instructions ... 15 
8  Package, transportation and storage ... 16 
Annex A ... 18 
Annex B ... 25 
Annex C ... 26 
Foreword
This Standard is the revision of YY/T Q283-1995 “Large Intestine Fiber Endoscope”.
Compared with YY/T 0283-1995, main differences in this Standard are as follows.
— Specify the name of standard;
— Add the classification of waterproof ability of product;
— Increase the quantity index of broken-fiber number;
— Add the coincidence requirements between illumination source and observation
view-field;
— Modify the requirements on product marking;
— Add the requirements on waterproof product;
— Add the requirements on biocompatibility;
— Modify the test method of view-field angle;
— Delete the requirements on sealing property in previous standard;
— Add Annex A (Normative).
For electrical connection part, it shall comply with GB 9706.1-1995 “Medical Electrical
Equipment - Part 1. General Requirements for Safety”, GB 9706.4-1999 “Medical Electrical
Equipment - Part 2. Particular Requirements for the Safety of High Frequency Surgical
Equipment”, and GB 9706.19-2000 “Medical Electrical Equipment - Part 2. Particular
Requirements for the Safety of Endoscopic Equipment”. The details are given in Annex A
(Normative).
Annex A and B of this Standard are normative; Annex C is informative.
This Standard replaces YY/T 0283-1995, since the date of issuance.
This Standard was approved by State Food and Drug Administration.
This Standard shall be under jurisdiction of National Technical Committee on Medical
Optical Instruments of Standardization Administration of China.
Drafting organization of this Standard. Medical Optical Equipment Factory of Shanghai
Medical Instruments Co., Ltd.
Main drafters of this Standard. Li Yafen, Sun Qi, and Shen Tianming.
This Standard was first-time published in November 1995.
Large Intestine Fiber Endoscope
1 Scope
This Standard specifies the classification, marking, requirements, test methods, inspection
rules, identification, operation instructions, packaging, transportation, and storage of large
intestine fiber endoscope.
This Standard is applicable to large intestine fiber endoscope (hereinafter referred as fiber
endoscope). This product is used to the examination and diagnosis of large intestine cavity
and can also be used in the relevant surgical operation.
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
(Apply to inspection of process stability)
GB 9706.1-1995 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.4-1999 Medical electrical equipment - Part 2. Particular requirements for the
safety of high frequency surgical equipment
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for the
safety of endoscopic equipment
GB 11244-2005 General requirements for the medical endoscope and endoscope
accessories
GB/T 14710-1993 The environmental requirements and test methods for medical
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and
testing
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 (ISO 10993-10. 2002, IDT)
YY 0466-2003 Medical devices - Symbols to be used with medical device labels
labelling and information to be supplied (ISO 15223. 2000, IDT)
4.3.5 Light spot at working distance shall fill-cover the whole view-field, without obvious
Clear observation range. 5 mm~100 mm.
4.4 Water supply and suction system
4.4.1 Supplied water can wash the surface of lens. The flow of supplied water shall not be
lower than 45 mL/min.
4.4.2 Suction shall be smooth. There is no liquid ejected backward at the places of button
and forceps channel socket. The suction flow must not be lower than 400 mL/min.
4.4.3 Suction tube shall be able to be washed by mild brush (only applicable to waterproof
type).
4.5 Bend-angle operation system
bend-angle part shall be able to do bend action under locking state. After locking is
released, it shall not affect the operating function of bend-angle hand-wheel. There is no
too-tight, too loose or stuck-up phenomenon during operation.
4.5.2 For upward and downward directions, the bend-angle of fiber endoscope shall be ≥
180°; for left-ward and right-ward directions, it shall be ≥ 160°. When it is bent at any angle,
the entry and exit of matching tools shall be smooth.
4.6 Sealing
4.6.1 Fiber endoscope shall be soaked in water as a whole. Its internal cavity can withstand
pressure of 22 kPa for 3 min; without air leakage (applicable to waterproof type).
shall not generate mist due to temperature variation that affect observation.
4.7 Marking
4.7.1 The inserted flexible tube shall be marked with length marking. The marked line and
words shall be legible.
4.7.2 There shall be direction-mark on top of filed.
4.7.3 Hand-wheel must have operation direction mark. The front bend direction shall be
consistent with the marked sign.
4.8 Dimension
The mechanical dimensions of fiber endoscope shall conform to Table 1.
Β -- View-field angle, unit. degree (°);
D -- Diameter of annulus, unit. mm;
L -- Distance BETWEEN the end-face of the centre of head-end window AND the centre
of measuring target, unit. mm.
5.2.5 Coincidence of illumination source and observation view-field
Visual inspection shall be conducted under the maximum illumination of the provided lamp
in accordance with Article 4.3.5.
5.2.6 Clear observation range
Fix the endoscope; adjust the distance between objective lens and the observed object.
shall be able to clearly see 1.0mm-wide strip; it shall conform to Article 4.3.6.
5.3 Water supply and suction performance test
5.3.1 Water supply performance
Turn on the air pump according to the usage requirements (pressure is not greater than
50kPa; flow rate is not greater than 500 L/h) to conduct water supper operation. Use the
measuring glass of which the minimum scale value is not greater 5mL and stopwatch to
measure the volume of the supplied water within 1min in accordance with Article 4.4.1.
GB/T 16886.5-2003. Cytotoxicity shall conform to the requirements in Article 4.9.1.
5.8.2 Sensitization shall be tested in accordance with the method specified in Chapter 6 of
5.8.3 Stimulus response shall be tested in accordance with the method specified in
Chapter 5 of GB/T 16886.10-2005. It shall conform to the requirements in Article 4.9.3.
5.9 Dissolved precipitate
For the test methods of dissolved precipitate, adopt the method specified in Annex C
(Informative) or the equivalent method. It shall conform to the requirements in Article 4.10.
5.10 Environmental test
Environmental test shall be conducted in accordance with the relevant requirements in
GB/T 14710-1993 and Article 4.11 of this Standard.
5.11 Safety test
9706.1-1995, GB 9706.4-1999, and GB 9706.19-2000. It shall conform to the requirements
in Artic...
   
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