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YY/T 0930-2014 English PDF

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YY/T 0930-2014: Medical endoscopes. Endotherapy device. Cytology brush
Status: Valid
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YY/T 0930-2014English209 Add to Cart 3 days [Need to translate] Medical endoscopes. Endotherapy device. Cytology brush Valid YY/T 0930-2014

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Standard similar to YY/T 0930-2014

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Basic data

Standard ID YY/T 0930-2014 (YY/T0930-2014)
Description (Translated English) Medical endoscopes. Endotherapy device. Cytology brush
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Classification of International Standard 11.040.90
Word Count Estimation 9,985
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard GB/T 14233.1-2008; GB/T 1962.1; GB/T 1962.2; GB/T 14233.2-2005; GB/T 16886.1-2011; YY/T 0149-2006; YY/T 1052-2004
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to endoscopic surgery can be used as a standalone product for cell brush. This Standard specifies the terms and definitions brush cells, requirements, test methods.

YY/T 0930-2014: Medical endoscopes. Endotherapy device. Cytology brush

---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 endoscopes. Endotherapy device. Cytology brush ICS 11.040.90 C40 People's Republic of China pharmaceutical industry standards Medical endoscope endoscopic instrument cell brush Issued on. 2014-06-17 2015-07-01 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. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit Mortem hospital. The main drafters. Zhang Qin Yuan, JIA Xiao Hang, Yan Qing, the Mao Xinxin, Chen Sheng come. Medical endoscope endoscopic instrument cell brush

1 Scope

This standard specifies the terms and definitions brush cells, requirements, test methods. This standard applies to endoscopic surgery can be used as a standalone product brush cells.

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) 6% for syringes, needles and other medical equipment (Luer) conical fitting GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2-2005 Infusion, transfusion, injection equipment - Part 2. Biological test methods GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test YY/T 0149-2006 stainless steel medical equipment corrosion test methods YY/T 1052-2004 mark surgical instruments

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 Cells brush cytologybrush One kind of endoscopic instruments used in conjunction with the designated endoscope in endoscopy procedure used to collect a sample of cells needed for pathology Diagnosis. 3.3 Inserting portion insertionportion Part of the cells of the brush, the portion can be inserted into the body's natural channels or surgical incision, or insertion of the endoscope instrument channel of the endoscope or instrument The instrument channel. 3.4 Maximum insertion portion width maximuminsertionportionwidth The maximum width of the outer portion of the insert. 3.5 Working length workinglength The maximum length of the brush cell insertion portion.

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