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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 methods specified by the
manufacturer, test the trocar repeatedly for 20 times.
6.12 Converter sealing property
Assemble the converter with the trocar; use the puncture needle of the converter’s
matching specifications; follow the test method for sealing property in Appendix A.
b) name and domicile, production address, contact information and production
license number of the product manufacturer;
c) number of the medical device registration certificate, and name, address and
contact information of the medical device registrant;
d) serial number of the technical requirements of the product;
e) production date and service life or expiry date;
f) words or symbols such as “refer to the instructions for other contents”.
Note: The graphic symbols given in YY/T 0466.1 can be used to meet the above
corresponding requirements.
8.2 Instructions
The instructions for trocar shall at least include the following:
a) product name, model and specification;
b) name and domicile, production address, contact information and production
license number of the product manufacturer;
c) number of the medical device registration certificate, and name, address and
contact information of the medical device registrant;
d) serial number of the technical requirements of the product;
e) production date and service life or expiry date;
f) treatment process for reuse, including cleaning, disinfection, packaging and
sterilization methods and the number of times of reuse or other restrictions;
g) product performance, main structure and scope of application;
h) contraindications, precautions and other contents that need to be warned or
prompted;
i) instructions for use or illustrations;
j) storage conditions and methods;
k) explanation of graphics, symbols, abbreviations, etc. used in medical device labels;
l) date of preparation or modification of the manual;
m) description of the skin-cutting function of the trocar (if applicable).
Appendix A
(Normative)
Test methods for gas barrier property and sealing property
A.1 Test equipment
A.1.1 Pressurization device, including gas source, pressure gauge (accuracy 0.1 kPa)
and connecting pipeline.
A.1.2 Water container, with a flat bottom.
A.2 Test procedure
A.2.1 Test procedure for gas barrier property:
a) Connect the head end of the trocar inserted with the puncture needle to the
pressurizing device, ensuring that there is no leakage at the connection;
b) Close the gas injection valve of the trocar; block the side hole of the puncture
sleeve and the air hole at the end of the puncture needle;
c) Place the trocar flat on the water container, making the highest point on the outer
surface of the trocar about 5 cm from the water surface; inject 4 kPa pressure gas
from the head of the trocar;
d) Pull out the puncture needle; keep the pressure at 4 kPa for 1 min; record the
number of air bubbles.
A.2.2 Test procedure for sealing property:
a) Connect the head end of the trocar inserted with the puncture needle to the
pressurizing device, ensuring that there is no leakage at the connection;
b) Close the gas injection valve of the trocar; block the side hole of the puncture
sleeve and the air hole at the end of the puncture needle;
c) Place the trocar flat on the water container, making the highest point on the outer
surface of the trocar about 5 cm from the water surface; inject 4 kPa pressure gas
from the tip of the trocar for 1 min; observe whether there is any leakage.
Appendix B
(Informative)
Test method for puncture property evaluation
B.1 Test equipment and test materials
B.1.1 Material testing machine
Accuracy: 0.1 N.
Test conditions: puncture speed 100 mm/min.
B.1.2 Fixture
Make sure that the trocar and test material are firmly fixed. Use a ring-shaped block to
support the lower part of the puncture part. Under the condition of providing sufficient
support for the test material, the space in the middle of the ring-shaped block ensures
that the puncture needle can completely penetrate the test material.
B.1.3 Test materials
Abdominal tissue of pigs, with skin on, shall be kept fresh for no more than 48 hours.
The size of one side shall be at least 10 times the outer diameter of the puncture sleeve.
B.2 Test procedure
B.2.1 Test procedure for the trocar with the function of skin cutting:
a) Mount the trocar and test material (B.1.3) on the fixture (B.1.2).
b) Start the testing machine (B.1.1); puncture the test material (B.1.3) until the
puncture sleeve completely enters the test material (B.1.3), and stop. Record the
maximum force value, which is the puncture force.
B.2.2 Test procedure for the trocar without the function of skin cutting:
a) Mount the trocar and test material (B.1.3) on the fixture (B.1.2).
b) Make a notch of the sleeve diameter on the epidermis of the test material (B.1.3),
and the notch shall completely cut through the dermis.
c) Adjust the position of the upper fixture, and confirm that the tip of the trocar is in
contact with the notch of the test material (B.1.3) but without force.
Appendix C
(Informative)
Test method for insertion/pullout property evaluation
C.1 Test equipment
C.1.1 Material testing machine
Accuracy: 0.1 N.
Test conditions: puncture/pullout speed 100 mm/min, puncture stroke L 10 mm (if the
structure of the trocar cannot meet the puncture stroke 10 mm, it is allowed to modify
the stroke, which needs to be indicated in the test report).
C.1.2 Fixture
Make sure that the puncture sleeve is not subjected to force in the radial direction and
is firmly fixed in the axial direction.
C.2 Test procedure
C.2.1 Clamp the puncture sleeve and the puncture needle on the fixture (C.1.2), and
ensure that the axis of the puncture needle coincides with the axis of the puncture sleeve.
C.2.2 Adjust the position of the upper fixture, and confirm that the needle head of the
puncture needle is in contact with the sealing ring on the puncture sleeve without force,
as shown in Figure C.1.
Note: If the puncture needle and the cannula have corresponding positions, make sure
that the relative position of the puncture needle and the cannula is correct.
C.2.3 Start the testing machine (C.1.1); insert the puncture needle into the puncture
sleeve to the set stroke position, and then stop; record the maximum force value, which
is the insertion force of the puncture needle, as shown in Figure C.2.
C.2.4 At the position where the test in C.2.3 ends, continue to pull out the puncture
needle at the set speed until it breaks...