Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by and is under the jurisdiction of National Medical Products Administration.
This standard is under the jurisdiction of SAC/TC 94 National Technical Committee on Surgical Instruments of Standardization Administration of China.
Disposable abdominal trocars
1 Scope
This standard specifies the structure, materials, requirements, test methods, type inspection, labels, instructions and packaging of disposable abdominal trocars.
This standard is applicable to the disposable abdominal trocars (hereinafter referred to as “trocars”) for puncturing human abdominal wall tissue to establish artificial pneumoperitoneum and operating surgical instrument channel during laparoscopic surgery.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1220 Stainless steel bars
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 3280 Cold rolled stainless steel plate sheet and strip
GB/T 4340.1 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 12672 Acrylonitrile-butadiene-styrene (ABS) resin
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use—Part 1: Chemical analysis methods
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 0466.1 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0806 Polycarbonate material for manufacture of infusion,transfusion and injection equipments for medical use and other medical devices
Pharmacopoeia of the People’s Republic of China (2015 Edition)
3 Structure and materials
3.1 Structure and identification
3.1.1 Trocar mainly consists of puncture set and puncture rod. The main parts of puncture set are sleeve, air injection valve, sheath cap (including seal) and air choke valve, and the surface of sleeve can be threaded; the piercing rod head end can be provided with a skin cutting/non-skin-cutting puncture bistoury. See Figure 1 and Table 1 for the structural type, specifications and basic dimensions of the trocar.
Keys:
1——(puncture set) sleeve;
2——(puncture set) air injection valve;
3——(puncture set) sleeve seat;
4——(puncture set) choke valve;
5——(puncture set) sheath cap (including seal);
6——puncture rod;
7——head end of puncture rod (with puncture bayonet).
Note: The trocar structure shown here is not the only one.
Figure 1 Schematic diagram of trocar
Table 1 Specification and basic dimension of trocar
In mm
Specification Inner diameter of puncture sleeve (φ) Working length of puncture sleeve (L)
Nominal value Limit deviation Nominal value Limit deviation
Code <5 +0.15
0 50≤L≤200 ±2
≥5 +0.3
0
3.1.2 The identification of the trocar shall contain at least the following elements and be as follows:
Example of identification:
The trocar with specification code 12, inner diameter of puncture sleeve 12.5 mm and working length of puncture sleeve 100mm is identified as 12×100-12.5.
3.2 Materials
The manufacturing materials of the main components of the trocars are as follows:
a) The puncture rod shall be made of polymer material or stainless steel material conforming to YY/T 0806 or GB/T 12672 (conforming to GB/T 1220);
b) The sleeve is made of polymer material conforming to YY/T 0806;
c) The puncture bistoury shall be made of stainless steel material conforming to GB/T 3280.
Note: Other materials that have been verified and evaluated as safe and meet the requirements of Clause 4 of this standard may also be used.
4 Requirements
4.1 Appearance
4.1.1 The external surface of the trocar shall be smooth and free from burrs, bubbles, impurities, cracks, sintered substances and other defects.
4.1.2 The outer surface of the trocar shall be free from visible accumulation of lubricant.
4.1.3 The specification mark on the trocar shall be clearly visible.
4.1.4 If the puncture rod head is equipped with a puncture bistoury, the bistoury shall be flat and free from rust, sharp edges, burrs and obvious pits; the cutting edge of the bistoury shall be free of notch, white mouth, roll mouth, crack, etc.
4.2 Dimension
The inner diameter φ of the sleeve of the trocar and the working length L of the puncture sleeve shall conform to the provisions in Table 1.
4.3 Surface roughness
If there is a puncture bistoury at the head end of the puncture rod, the surface roughness Ra of the cutting edge surface of the bistoury is less than or equal to 0.8 μm.
4.4 Hardness
If the puncture rod is provided with a skin-cutting bistoury, the bistoury shall be heat treated with a hardness of not less than 650HV10.
4.5 Flexibility
4.5.1 The opening and closing of the air injection valve of the trocar shall be flexible, and there shall be no blocking or sticking phenomenon.
4.5.2 If the sheath cap is detachable, its assembly and disassembly shall be flexible and convenient, and there shall be no blocking or sticking phenomenon.
4.5.3 If the puncture rod is equipped with a puncture bistoury at the head end, the puncture bistoury shall be able to retract flexibly without blocking or sticking.
4.6 Compatibility
4.6.1 The puncture sleeve should be well matched with the puncture rod, and there shall be no sticking phenomenon when inserting and pulling.
4.6.2 The maximum fit gap between the puncture sleeve port and the puncture rod shall not be greater than 0.3 mm.
4.6.3 When the puncture rod is fully inserted into the puncture sleeve, the tapered part at the head end of the puncture rod shall be completely exposed.
4.7 Fastness of connections
4.7.1 If the sheath cap is detachable, it shall be firmly connected with the puncture sleeve without disconnection at the joint.
4.7.2 The puncture sleeve is firmly connected, and the sleeve shall not be separated from sleeve seat.
4.7.3 The puncture rod is firmly connected and shall not be separated.
Foreword i
1 Scope
2 Normative references
3 Structure and materials
4 Requirements
5 Test method
6 Type inspection
7 Labels and instructions
8 Packaging
Annex A (Normative) Test method for air barrier and sealing performance
Annex B (Informative) Test method for puncture performance evaluation
Annex C (Informative) Test method for inserting and drawing performance evaluation
