YY/T 1783-2021 English PDF (YYT1783-2021)

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YY/T 1783-2021: Endoscopic surgical instruments -- Reusable abdominal trocar
YY/T 1783-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
CCS C 36
Replacing YY 0672.1-2008
Endoscopic surgical instruments - Reusable abdominal
trocar
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: APRIL 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Structure and materials ... 6
5 Requirements ... 9
6 Test methods ... 11
7 Type inspection ... 13
8 Label, instructions... 13
9 Packaging, transportation and storage ... 15
Appendix A (Normative) Test methods for gas barrier property and sealing property16
Appendix B (Informative) Test method for puncture property evaluation ... 17
Appendix C (Informative) Test method for insertion/pullout property evaluation ... 19
Endoscopic surgical instruments - Reusable abdominal
trocar
1 Scope
This document specifies the structure, materials, requirements, test methods, type
inspection, labels, instructions, packaging, transportation and storage of reusable
abdominal trocar.
This document applies to the reusable abdominal trocar (hereinafter referred to as trocar)
for puncturing human abdominal tissue to establish artificial pneumoperitoneum and
operating surgical instrument channels during endoscopic surgery.
2 Normative references
The following documents are normatively referenced in this document and are
indispensable for its application. For dated references, only the version corresponding
to that date is applicable to this document; for undated references, the latest version
(including all amendments) is applicable to this document.
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings
GB/T 4340.1-2009, Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 16886 (all parts), Biological evaluation of medical devices
YY/T 0149-2006, Medical instruments of stainless steel - Test methods of corrosion
resistance
YY/T 0294.1-2016, Surgical instruments - Metallic materials - Part 1: Stainless steel
3 Terms and definitions
The following terms and definitions are applicable to this document.
3.1 Gas barrier property
The gas resistance of the trocar after the puncture needle is pulled out of the puncture
sleeve.
3.2 Sealing property
The trocar can also be made of other materials that have been verified and evaluated as
safe and effective.
5 Requirements
5.1 Appearance
5.1.1 The outer surface of the trocar shall be smooth and clean, and there shall be no
defects such as burrs, air bubbles, impurities, cracks, pores, grooves, sintered objects,
and rust on the surface.
5.1.2 There shall be no visible accumulation of lubricant on the trocar surface.
5.1.3 The body of the trocar shall at least have the specification code, batch number,
manufacturer’s name (or trademark), without dislocation or skew, and the marks shall
be clearly visible.
5.1.4 If the needle head of the puncture needle is equipped with a puncture knife, the
puncture knife shall be flat and free from rust, sharp edges, burrs and obvious pits; the
cutting edge of the puncture knife shall be free of gaps, white edges, curls, cracks, etc.
5.2 Dimensions
The inner diameter ϕ of the puncture sleeve and the working length L of the puncture
sleeve shall meet the requirements in Table 1.
5.3 Surface roughness
The surface of the trocar can be treated to be bright or dull, and the maximum surface
roughness Ra of the metal parts shall not be greater than 0.4 μm for bright and not
greater than 0.8 μm for dull.
5.4 Flexibility
5.4.1 The gas injection valve of the trocar shall be opened and closed flexibly, and there
shall be no blockage or stagnation.
5.4.2 If the needle head of the puncture needle is equipped with a puncture knife, the
puncture knife shall be able to retract flexibly, and there shall be no blockage or
stagnation.
5.5 Fitting performance
5.5.1 The puncture sleeve and the puncture needle shall fit well, and there shall be no
stagnation during insertion or pullout.
5.5.2 The maximum fit clearance between the puncture sleeve and the puncture needle
shall not be greater than 0.3 mm.
5.5.3 When the puncture needle is fully inserted into the puncture sleeve, the tapered
part of the puncture needle head shall be fully exposed.
5.6 Gas barrier property and sealing property
5.6.1 The trocar shall have a good gas barrier property, and the number of air bubbles
shall be less than 20 under the pressure of 4 kPa.
5.6.2 The trocar shall have a good sealing property, and there shall be no leakage under
the pressure of 4 kPa.
5.7 Hardness
The hardness of the puncture needle head shall be ≥210 HV0.2.
5.8 Gas injection valve interface
The gas injection valve shall be equipped with a Luer lock connector, in line with the
provisions of GB/T 1962.2.
5.9 Puncture, insertion and pullout properties
The puncture property and insertion/pullout property of the trocar shall be evaluated,
which shall comply with the manufacturer’s regulations.
5.10 Corrosion resistance
The corrosion resistance of trocar parts made of stainless steel shall not be lower than
the requirements of grade b in 5.4 of YY/T 0149-2006.
5.11 Reusability
The trocar shall be easy to disassemble and clean. After repeated cleaning, disinfection
and sterilization 20 times according to the method specified in the instruction manual,
there shall be no damage or corrosion marks that cannot be removed by wiping, and the
regulations in 5.1.3, 5.4, 5.5, 5.6 and 5.9 shall be met.
Note: If the manufacturer claims that the service life exceeds 20 times, the manufacturer
shall provide verification information.
5.12 Converter sealing property
A converter, if equipped and used with the trocar, shall have good sealing property, and
there shall be no leakage when subjected to 4 kPa air pressure.
5.13 Connection firmness
5.13.1 If the sheath cap is detachable, it shall be firmly connected with the puncture
cannula seat, and there shall be no disengagement at the connection.
b) Hardness: 0 HA ~ 30 HA;
c) Thickness: 25 mm ~ 30 mm.
6.5 Fitting performance
6.5.1 Imitate the operation, insert and pull out the puncture needle in the puncture sleeve
3 times.
6.5.2 Use a 0.30 mm through needle to detect a circle along the port of the puncture
cannula, and observe whether the through needle can be inserted into the fit clearance.
6.5.3 Imitate the operation and observe visually.
6.6 Gas barrier and sealing property
Follow the method specified in Appendix A.
6.7 Hardness
According to the method specified in GB/T 4340.1-2009, calculate the average value
of the three measurement points.
6.8 Gas injection valve interface
The Luer lock joint of the gas injection valve shall be tested according to the method
specified in GB/T 1962.2.
6.9 Puncture, insertion and pullout properties
See Appendix B and Appendix C for the test methods for the evaluation of puncture
property and insertion/pullout property.
Note: The method in the appendix is only a test method for uniformly evaluating the
puncture property and insertion/pullout property of the trocar.
6.10 Corrosion resistance
Follow the boiling water test method in YY/T 0149-2006.
6.11 Reusability
According to the cleaning, disinfection and sterilization method...