YY/T 1797-2021Endoscopic surgical instruments-Endoscopic cutter stapler and reload (English PDF)

4.1 Staple materials

4.2 Appearance

4.2.1 The stapler shall be smooth in appearance, clear in outline, free from defects such as burrs and scratches; the metal outer surface of the weld shall be free from defects such as cracks, welding slags, and weld tumors. Specifications of the staple line (nominal value) Staple original height (nominal value)

4.2.2 The shape and structure of the stapler head end shall be blunt, without sharp edges or corners.

4.2.3 The surface of the stapler (assemblies and stapler rod parts) shall be matt.

4.3 Corrosion resistance

The corrosion resistance of the metal parts on the outer surface of the stapler head end shall not be lower than that specified in 5.4b) of YY/T 0149-2006.

4.4 Surface roughness

The roughness Ra of the metal outer surface of the stapler assemblies and the stapler rod parts shall not be greater than 1.6 µm.

4.5 Dimensions

The basic dimensions of the stapler shall meet the requirements of Table 1.

4.6 Hardness

The hardness of the cutter knife shall not be less than 377HV0.2.

4.7 Assembly

4.8 Flexibility

4.8.1 The opening and closing of the stapler jaws shall be flexible, and there shall be no blocking phenomenon.

4.8.2 The joint structure and rotational structure of the stapler shall be flexible and free of obstacles.

4.9 Performance

4.9.1 The connection between the stapler body and the assemblies shall be firm and reliable.

4.9.5 The stapler shall be available for one-hand operability.

4.9.6 The stapler shall be provided with good stapling and cutting performance. When the assemblies are replaced, the cutting edge after each anastomosis shall be neat and free of burrs, and the distal-end length of the staple line shall be at least 1.5 times longer than the cutting line. The staples after each anastomosis shall be shaped like "B".

4.12 Protective device

4.12.1 The stapler shall have an empty staple cartridge protective device, so that it cannot be fired when the empty staple cartridge is installed by mistake.

Note: Empty cartridge refers to fired assemblies.

4.13 Matching performance with trocar

The stapler shall be smoothly inserted into the matched trocar specified in the manual, and pulled out smoothly.

4.14 Sterility

The stapler shall be sterilized by a validated sterilization process and the product shall be sterile.

4.15 Bacterial endotoxin

The bacterial endotoxin content of the stapler used for blood vessels shall be less than or equal to 20 EU/piece.

4.17.4 Reducing substances

The difference of the consumption of potassium permanganate solution [c(1/5KMnO4)

= 0.01 mol/L], compared with the same volume of blank control solution in the same batch, shall be less than or equal to 2.0 mL.

4.17.5 Evaporation residue

The total dry residue of the dissolution solution shall be less than or equal to 2.0 mg.

4.18 Biological evaluation

The stapler shall be biologically evaluated according to the provisions of the GB/T 16886 series standards, and there shall be no biocompatibility hazards.

4.19 Instruction manual

5.1 Staple materials

5.2 Appearance

Under the illumination of 300 lx ~ 750 lx, observe by normal or corrected visual acuity, and rub with hands, which shall meet the requirements of 4.2.

5.3 Corrosion resistance

Carry out the test according to the boiling water test method in YY/T 0149-2006, which shall meet the requirements of 4.3.

5.4 Surface roughness

The surface roughness shall be tested by the sample block comparison method or the profile method specified in GB/T 10610, which shall meet the requirements of 4.4. Use the profile method during arbitration.

5.7 Assembly

5.7.1 Imitate the use action to load and replace assemblies, which shall comply with the provisions of 4.7.1.

5.8 Flexibility

After correctly loading the assemblies, imitate the use action to check the flexibility, which shall meet the provisions of 4.8.

5.9 Performance

5.9.3 Use the instrument to clamp the EVA low-foamed plate sample whose total thickness is 1/2 ~ 2/3 the original height of the staples; fix the stapler body on the fixture; apply a push-pull device to clamp the EVA low-foamed plate sample; then, measure the clamping force in axial direction, which shall comply with the provisions of 4.9.3.

5.9.6 Imitate the use action to match the EVA low-foamed plate sample whose total thickness is 1/2 ~ 2/3 the original height of the staples, where the cutter knife is assembled to the assembly,

5.9.7 Carry out the test according to the method specified in Appendix B, which shall meet the requirements of 4.9.7.

5.9.8 Imitate the use action to fire the stapler, which shall comply with the provisions of 4.9.8.

5.10 Cutter knife sharpness

Carry out the test according to the method specified in Appendix C, which shall comply with the provisions of 4.10.

5.17.1 Test liquid preparation

Take the sample; put it in a glass container according to the ratio of 0.2 g of sample to 1 mL of test water (grade-2 water in accordance with GB/T 6682-2008); leach at the constant temperature of 37 °C ± 1 °C for 24 h; separate the sample from the liquid; cool to room temperature; use it as a test solution.

Take the same volume of test water and place it in a glass container; prepare a blank control solution in the same way.

5.17.2 Appearance

Take the test solution and observe the solution visually, which shall meet the requirements of 4.17.1.

5.17.3 pH value

5.18 Biological evaluation

The stapler shall be biologically evaluated in accordance with the provisions of the GB/T 16886 series standards, which shall comply with the provisions of 4.18.

5.19 Instruction manual

Observe visually, which shall meet the provisions of 4.19.

7.1 Label

The label of the stapler shall have at least the following contents or symbols.

7.2 Instruction manual

The instruction manual for the stapler shall contain at least the following. […]