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YY/T 1297-2015 English PDF

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YY/T 1297-2015: Medical endoscope. Endotherapy device. Curette
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1297-2015189 Add to Cart 3 days Medical endoscope. Endotherapy device. Curette Valid

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Basic data

Standard ID: 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: 9,922
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
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State 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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical endoscope. Endotherapy device. Curette ICS 11.040.99 C40 People's Republic of China pharmaceutical industry standards Medical endoscope endoscopic instrument 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.
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