YY/T 1797-2021 English PDF (YYT1797-2021)

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YY/T 1797-2021: Endoscopic surgical instruments - Endoscopic cutter stapler and reload
YY/T 1797-2021
(Endoscopic surgical instruments Endoscopic surgical instruments and components)
ICS 11.040.30
C36
People's Republic of China Pharmaceutical Industry Standard
Endoscopic surgical instruments Laparoscopic cutting stapler and components
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Surgical Instrument Standardization Technical Committee (SAC/TC94).
This standard was drafted by. Shanghai Medical Device Testing Institute, Changzhou Weike Medical Device Co., Ltd., Shandong Weirui Surgical Medical Products Co., Ltd.
Co., Ltd. and Shanghai Yisi Medical Technology Co., Ltd.
The main drafters of this standard. Huang Shuze, Jiang Shihua, Yao Daqiang, Liu Qingfeng, Zou Fengping, Wang Wei, Zhang Qijin, Wang Lei, Yao Yao, Wang Hailong,
Chen Zhaowei and Bao Minghui.
Endoscopic surgical instruments Laparoscopic cutting stapler and components
1 Scope
This standard specifies the structure, material, requirements,
Test methods, type inspection, labels, instructions and packaging.
This standard applies to single-use endoscopic cutting staplers and components in endoscopic surgery.
Note. This stapler is suitable for anastomotic creation and stump or incision closure in digestive tract reconstruction and organ resection.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 228.1 Tensile Test of Metallic Materials Part 1.Test Method at Room Temperature
GB/T 1220 stainless steel rod
GB/T 3280 Stainless Steel Cold Rolled Steel Plate and Strip
GB/T 4237 Stainless steel hot-rolled steel sheet and strip
GB/T 4340.1 Vickers Hardness Test for Metal Materials Part 1.Test Method
GB/T 6682-2008 Specifications and test methods for water used in analytical laboratories
GB/T 10610 Product Geometric Specifications (GPS) Surface Structure Profile Method for Evaluation of Surface Structure Rules and Methods
GB/T 13810 Titanium and titanium alloy processing materials for surgical implants
GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods
GB/T 16886 (all parts) Biological evaluation of medical devices
YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices
YY 0167-2005 Non-absorbable surgical sutures
Pharmacopoeia of the People's Republic of China
3 Structure and materials
3.1 The stapler consists of a body and components. According to the design of the cutting blade, the stapler is divided into the cutting blade assembly type and the cutting blade assembly type.
Body type. According to the joint structure, it is divided into bending type and non-bending type.
The cutting knife is assembled on the component type endoscopic cutting stapler, and the body is generally composed of a firing rod, a rod, a knob of the joint head, a rotating collar, a firing button, and a return.
The assembly is generally composed of an anvil seat, a staple cartridge, a staple cartridge seat, a cutting knife and an anastomotic staple.
The cutting knife is assembled on the body type endoscopic cutting stapler. The body generally consists of an anvil seat, joint head, rod, rotary knob, adjustment paddle, and blade direction.
Switch button, firing indicator window, blade direction indicator window, release button, handle, closing handle, firing handle, cutting knife, staple cartridge seat, etc., components
It is generally composed of staple cartridges and staples.
3.2 See Figure 1, Figure 2, Figure 3, Figure 4 and Table 1 for the structure and basic dimensions of the stapler.
Note. The structure of the stapler shown is not the only type.