YY 0876-2013Linear cutter stapler and cartridge (English PDF)

4.3 Assembly

4.3.1 The replacement of stapler components shall be convenient and reliable.

4.3.2 After the assembly is shaken, the staples shall not be exposed on the surface of the staple cartridge.

4.4 Sharpness

The cutting edge shall be sharp. The cutting force shall not be greater than 0.80N.

4.5 Anastomotic and cutting performance

4.5.1 The stapler shall have good anastomotic and cutting performance, replaceable components. Make no less than 5 cutting anastomosis. The staples after each anastomosis shall be shaped like a "B".

4.5.2 At the same time, the cutting edge after each anastomosis shall be neat. There shall be no burrs.

4.5.3 The length of each staple line is at least 1.5 times longer than the length of the cutting line.

4.6 Pressure resistance

The anastomotic stoma after anastomosis shall be able to withstand a pressure of not less than 3.6 x 10^3Pa. Leak no more than 10 drops within 15s.

4.7 Safety device

The stapler shall have an empty cartridge safety device. Maintain its reliability.

NOTE: Empty cartridges refer to fired components.

4.8 Surface roughness

The roughness Ra of the metal outer surface of the stapler shall not be greater than 0.8µm.

4.9 Package seal

4.9.1 The stapler and cartridge shall be packaged in good condition. The adhesive seal area shall be free of channels or perforations.

4.9.2 The packaging and sealing peel strength of the stapler and cartridge shall not be less than 0.10N/mm. After peeling off, the two contact surfaces shall be smooth and continuous. There is no delamination or tearing.

4.10 Appearance

4.10.1 The stapler has a smooth shape, clear outline, no burrs, scratches and other defects.

4.10.2 The handwriting and signs on the outer surface of the stapler shall be clear. There shall be no defects such as dislocation and skew.

4.10.3 There shall be no burrs, dents and other defects on the surface of the staples.

4.11 Size

The size of the stapler and cartridge shall meet the requirements of Table 1.

4.12 Sterilization

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

4.12.2 If ethylene oxide is used for sterilization, the residual amount of ethylene oxide in the stapler and cartridge shall not exceed 10µg/g.

4.13 Biological evaluation

4.13.1 Staples, when they use pure titanium, titanium alloy materials and pure tantalum materials whose surface is modified, or other materials not specified in Table 2, shall be biologically evaluated according to the provisions of GB/T 16886.1. The evaluation results shall be free of biocompatibility hazards.

4.13.2 The cytotoxicity score of the anti-staple seat and the staple cartridge shall not be greater than 1.

4.13.3 The level of delayed type hypersensitivity reaction of the anti-staple seat and the staple cartridge shall not be greater than 1.

4.13.4 The score of the intradermal reaction of the anti-staple seat and the staple cartridge shall not be greater than 1.

5.1 Material inspection

The chemical composition inspection of pure titanium and titanium alloy materials made of staples is carried out according to the method specified in GB/T 13810.

The chemical composition test of the tantalum wire material made of staples is carried out according to the method specified in ISO 13782.

The tensile strength of staple material is carried out according to the method specified Carry out the test according to the method specified in Annex D, which shall meet the requirements of 4.9.1.

5.9.2 Peel strength test

Carry out the test according to the method of Annex E, which shall meet the requirements of 4.9.2.

5.10 Appearance inspection

Visually inspect and touch with hands, which shall meet the requirements of 4.10.

5.11 Size inspection

Measure with a general-purpose measuring tool or a special measuring tool, which shall comply with the provisions of 4.11.

5.12 Sterility and ethylene oxide residue inspection

5.12.1 Carry out according to the method in Pharmacopoeia of the People's Republic of China (2010 Edition) Part II, which shall comply with the provisions of 4.12.1.

5.12.2 The determination of the residual amount of ethylene oxide shall be carried out according to the method specified in GB/T 16886.7, which shall meet the requirements of 4.12.2.

5.13 Biological evaluation

5.13.1 Staples made of pure titanium, titanium alloy materials and pure tantalum materials with modified surfaces or other materials not specified in Table 2 shall be biologically evaluated according to the items specified in GB/T 16886.1. It shall comply with the provisions of 4.13.1.

5.13.2 Carry out according to the method specified in 8.2 (extract test) of GB/T 16886.5-2003, which shall meet the requirements of 4.13.2.

5.13.3 Carry out according to the method specified in 7.4 (maximum dose test) in GB/T 16886.10-2005, which shall meet the requirements of 4.13.3.

5.13.4 Intradermal reaction test

Carry out according to the method specified in GB/T 16886.10-2005. (intradermal reaction test in Annex B.2), which shall meet the requirements of 4.13.4.

6.1 Marks, instructions for use

6.1.1 The body of each stapler shall have the manufacturer's code or trademark.

6.1.2 Packaging marks for the stapler and cartridge:

a) The single package mark shall comply with the provisions of 4.1.3 in YY/T 0171-2008;

b) The outer packaging mark shall comply with the provisions of 4.2.3 in YY/T 0171-2008.

6.1.3 The mark on the certificate shall comply with the provisions of 4.3 in YY/T 0171-2008.

6.2 Instructions for use

The preparation of the instructions for use shall comply with the provisions of Chapter 5 in YY/T 0171-2008.

7.1 Packaging

7.1.1 Stapler packaging

7.1.1.1 The stapler shall be packaged in a single unit. Sterility shall be maintained during the storage period.

7.1.1.2 The single package shall leave traces of opening after opening.

7.1.1.3 Put the single package into the packaging box. The instructions for use and certificate of conformity shall be attached.

7.1.2 Cartridge packaging

7.1.2.1 The cartridge shall be packaged in a single unit. Sterility shall be maintained during the storage period.

7.1.2.2 The single package shall leave traces of opening after opening.

7.1.2.3 Put several single packages into the packaging box. The instructions for use and certificate of conformity shall be attached.

7.2 Transportation and storage

7.2.1 The outer packaging of the stapler and cartridge shall ensure that they will not be damaged under normal transportation and storage conditions.

7.2.2 The words or signs on the outer packaging shall be guaranteed not to be blurred for a long time.

C.1 Definition

C.1.1 Anastomosis (suture) pressure resistance: It refers to the pressure that the anastomosis (suture) can withstand after the tissue or organ is anastomosed (sutured) with a stapler.

C.1.2 Anastomosis: The incision of the tissue or organ is butted and completely anastomosed and unobstructed. C.1.3 Suture: Closure of the stump incision.

C.2 Instrument requirements

C.2.1 The instrument shall be manufactured according to the drawings and documents approved by the prescribed procedures.

C.2.2 The power supply voltage required by the instrument: 220V+22V. The power supply frequency: 50Hz±0.5Hz. C.2.3 Measurement unit of the instrument: kPa (kilopa). C.2.4 The instrument's indication range: 0~6kPa. Indication error: ±0.12kPa. C.2.5 The instrument has water inlet, drain and stop actions. C.2.6 The instrument's pressure gauge is checked every other year.

C.2.7 The water inlet and drainage pipes of the instrument shall be unobstructed. The control device shall be reliable.

C.3 Test material

C.3.1 The test material is fresh pig intestines. In vitro time is less than 24h. Store in the range of 5°C~15°C. No ice crystals are formed.

C.3.2 The intestinal cavity shall be cleaned before the test. Remove the intestinal fat and mesentery at the commissure to be anastomosed (sutured).

C.4 Test methods

C.4.1 Choose two bowels for side-to-side anastomosis.

D.1 Overview

This appendix uses the dye penetration test method to test the sealing performance of packaging seals.

D.2 Instrument and reagent preparation

D.2.1 1L beaker. D.2.2 25mL graduated cylinder. D.2.3 0.0005g balance.

D.3 Permeate formula

D.3.1 Add 5g of surfactant TritonX-100 to 100mL of grade three test water in compliance with GB/T 6682. Stir well.

D.3.2 Add grade three test water to 1000mL in C.3.1. Stir well again.

D.3.3 Take 0.5g of toluidine blue and add it to C.3.2. Stir well.

D.4 Test steps

D.4.1 During the test, the test personnel shall check that the test environment temperature is within the range of 23°C ± 2°C, and the relative humidity is within the range of 50% ± 2%.

D.4.2 Aspirate enough permeate with a syringe. Inject it into the sterilized primary package at the center of the package. Make the liquid cover the height of the sealing edge to 5mm.

Attention: Avoid splashing liquids on the skin. If necessary, wash hands with soap immediately to avoid damage to the skin.

D.4.3 The time for the permeation to cover the sealing edge shall be controlled within the range of 5s~20s. […]