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YY/T 1297-2015

Search Result of Chinese Standard: 'YY/T 1297-2015'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1297-2015English169 Add to Cart Days<=3 Medical endoscope. Endotherapy device. Curette Valid YY/T 1297-2015
YY/T 1297-2015Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY/T 1297-2015; YY/T1297-2015
Description (Translated English): Medical endoscope. Endotherapy device. Curette
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.99
Word Count Estimation: 8,813
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Quoted Standard: GB/T 1962.1; GB/T 1962.2; GB/T 4340.1; GB 9706.4; GB 9706.19; GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.8; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17; GB/T 16886.18; YY/T 0149
Drafting Organization: Zhejiang Medical Device Testing
Administrative Organization: National Medical Optics and Instruments Standardization Sub-Technical Committee
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization: China Food and Drug Administration
Issuing agency(ies): China Food and Drug Administration
Summary: This Standard specifies the endoscopic instrument curette scope, terms and definitions, requirements, test methods. This Standard applies to the use of endoscopic surgical curette.


YY/T 1297-2015
Medical endoscope. Endotherapy device. Curette
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical endoscope endoscopic instrument curette
Medicalendoscopes-Endotherapydevice-Curette
Issued on: 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted: Zhejiang Medical Device Testing, the State Food and Drug Administration Medical Device Quality Supervision, Inspection and Hangzhou
center.
The main drafters: Zhang Qin Yuan, Yan Qing, the Qi Weiming, JIA Xiao Hang, Wen Yan.
Medical endoscope endoscopic instrument curette
1 Scope
This standard specifies the endoscopic instrument curette scope, terms and definitions, requirements, test methods.
This standard applies to the use of endoscopic surgical curette.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1962 (all parts) syringes, needles and other medical equipment - 6% (Luer) conical fitting
GB/T 4340.1 metallic materials - Vickers hardness test - Part 1: Test methods
GB 9706.4 Medical electrical equipment - Part 2-2: requirements for the safety of high frequency surgical equipment
GB 9706.19 Medical electrical equipment - Part 2: Safety of endoscopic equipment
GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1: Chemical analysis
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2: Biological test methods
Biological evaluation of GB/T 16886 (all parts) Medical Devices
YY/T 0149 stainless steel medical equipment corrosion test methods
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Endoscopic instruments endotherapydevice
In endoscopic surgery, to check, diagnostic or therapeutic purposes, and the endoscope through the same or different channels to enter the body's natural hole
Tract or surgical incision medical devices.
NOTE: Some endoscopic instruments include an endoscopic instrument to guide the instrument inserted. Some endoscopic instruments are also included in the observation using the endoscope, for safety
Purposes different from the endoscope into the opening of the body of the instrument.
3.2
Curette curette
One kind with the corresponding endoscope with an endoscopic instrument used mainly by the handle, shank, head shaving composition to Sao scrape or cut out scraping way to remove
Target tissue or foreign bodies.
3.3
Inserting portion insertionportion
Part of the curette, which is partially inserted into the human or natural orifice surgical incision, or insertion of the endoscope instrument channel, or endoscopic accessory
Instrument channel, instrument channel of the endoscope or instrument.
3.4
Maximum insertion portion width maximuminsertionportionwidth
The maximum width of the outer portion of the insert.
Related standard:   YY 1296-2016  YY 1298-2016
   
 
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