YY/T 0941-2014Medical endoscopes - Endotherapy devices - Punch forceps (English PDF)

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. Zhang Qin Yuan, JIA Xiao Hang, Yen to green. Medical endoscope endoscopic instruments bite cutting pliers

1 Scope

YY/T 0941 is the product standard for endoscopic punch forceps, the biting instrument used to take a bite of tissue or bone through an endoscope, in arthroscopy, sinus surgery and gastrointestinal work. It is the companion to YY/T 0944 on separating forceps in the Chinese endotherapy instrument series. A punch has to cut cleanly and completely with each closure rather than crushing and tearing, which puts the requirement on the cutting edge geometry, the hardness of the jaws and how both survive resterilisation, together with the mechanical integrity that keeps a jaw from separating inside a joint. For a manufacturer or an importer of endoscopic punches and rongeurs for the Chinese market, this is the governing product standard.

This standard specifies the cutting pliers bite the scope, terms and definitions, requirements, test methods. This standard applies to the use of endoscopic surgical cutting pliers bite.

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 4340.1-2009 metal 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 0149-2006 stainless steel medical equipment corrosion test methods

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Bite cutting pliers punchforceps One kind specified endoscope with endoscopic instruments used mainly by the handle, clamp lever clamp composition for bite and cut tissue. NOTE. The organization does not include bone tissue.

3.2 Inserting portion insertionportion Biting part of cutting pliers, 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 Cutting pliers bite the maximum length of the insertion portion.

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