YY/T 0943-2014 English PDF (YY/T0943-2014)

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YY/T 0943-2014: Medical endoscopes - Endotherapy device - Needle forceps
YY/T 0943-2014
Medical endoscopes.Endotherapy device.Needle forceps
ICS 11.040.99
C40
People's Republic of China pharmaceutical industry standards
Medical endoscope endoscopic instruments Needle Holders
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 content of this document may involve patents, publication 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 Institute, the State Food and Drug Administration Medical Device Quality Supervision, Inspection and Hangzhou
center.
The main drafters of this standard. JIA Xiao Hang, Zhang Patio, Yan Qing come.
Medical endoscope endoscopic instruments Needle Holders
1 Scope
This standard specifies the scope of the needle holder, the terms and definitions, requirements, test methods.
This standard applies to needle holder used in endoscopic surgery.
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 4340.1-2009 metal materials - Vickers hardness test - Part 1. Test methods
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 0043-2005 medical suture needle
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY 0167-2005 non-absorbable surgical suture
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Needle Holders needleforceps
One kind specified endoscope with endoscopic instruments used mainly by the handle, clamp lever clamp composition, for holding the needle.
3.2
Inserting portion insertionportion
Part of the needle holder, which can be inserted into the body part natural orifice or a surgical incision, or insertion of the endoscope instrument channel, or attached to an endoscope
Member of the instrument channel, instrument channel of the endoscope or instrument.
3.3
Maximum insertion portion width maximuminsertionportionwidth
The maximum width of the outer portion of the insert.
3.4
Working length workinglength
The maximum length of the insertion portion of the holding pin pliers.
3.5
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.