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This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents.
This document replaces YY 0672.1-2008 Endoscopic instruments—Part 1: Trocars for laparoscope use, in addition to editorial changes, the main technical changes are as follows:
——A trocar with skin cutting ability is added (see 4.1.1);
——The requirements for materials are modified (see 4.2; 3.2 of Edition 2008).
——The requirements for trocar appearance are modified (see 5.1; 4.2 of Edition 2008);
——The requirements for surface roughness are modified (see 5.3; 4.7 of Edition 2008);
——The performance of trocar with skin cutting ability is added (see 5.4.2);
——The requirements for gas barrier property and sealing property are modified (see 5.6; 4.5 of Edition 2008);
——The requirements for hardness are modified (see 5.7; 4.6 of Edition 2008).
——The requirements for interface of gas injection valve are added (see 5.8);
——The evaluation requirements of puncture and plugging property are added (see 5.9);
——The requirements for corrosion resistance are modified (see 5.10; 4.8 of Edition 2008);
——The requirements for reuse property are added (see 5.11);
——The requirements for sealing property of converter are added (see 5.12);
——The requirements for connection firmness are added (see 5.13);
——The requirements for packaging identification and instruction are added (see 5.14);
——The test method for property of trocar with skin cutting ability is added (see 6.4.2);
——The test method for fitting property are modified (see 6.5.2; 5.4.2 of Edition 8);
——The test methods for gas barrier property and sealing property are modified (see 6.6; 5.5 of Edition 2008);
——The test methods for puncture and plugging property are added (see 6.9);
——The test method for reuse property is added (see 6.11);
——The test method for sealing property of converter is added (see 6.12);
——The test method for connection firmness is added (see 6.13);
——The test methods for packaging identification and instruction are added (see 6.14);
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 standard shall not be held responsible for identifying any or all such patent rights.
This document was proposed by the National Medical Products Administration of People’s Republic of China.
This document is under the jurisdiction of National Technical Committee on Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94).
Drafting organizations of this document: Shanghai Institute of Medical Device Testing, Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd, Hangzhou Kangji Medical Instrument Co., Ltd, Beijing Institute of Medical Device Testing, Hangzhou Tonglu Medical Optical Instrument Co., Ltd.
Chief drafters of this document: Huang Shuze, Xu Shengyuan, Zhong Ming, Hu Guangyong, Wang Caijuan, Zhang Lihua, Gui Chengkui, Tnag Wenpeng, Geng Xin, Huang Jiajin.
The previous edition of this document is as follows:
——YY 0672.1-2008.
Endoscopic surgical instruments—
Reusable abdominal trocar
1 Scope
This document specifies the structure, materials, requirements, test methods, type inspection, label and instruction, packaging, transportation and storage for reusable abdominal trocar.
This document is applicable to the reusable abdominal trocar (hereinafter referred to as trocar) for establishing artificial pneumoperitoneum and surgical instrument access by puncturing into body abdominal tissue during laparoscopic surgery.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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
For the purposes of this document, the following terms and definitions apply.
3.1
gas barrier property
gas barrier ability of the trocar after pulling the puncture needle out of the puncture sleeve
3.2
sealing property
sealing ability of the trocar after inserting the puncture needle into the puncture sleeve
3.3
puncture force
maximum force required for the trocar to puncture the test material at a certain speed
3.4
insertion force/ pullout force
maximum force required when the puncture needle of the trocar is inserted/pulled out of the puncture sleeve
4 Structure and materials
4.1 Structure and identification
4.1.1 The trocar is mainly composed of a puncture sleeve and a puncture needle, and may be equipped with a converter. The main components of the puncture sleeve are composed of sleeve, gas injection valve, sleeve socket, sheath cap (including sealing element) and gas barrier valve, and the surface of the sleeve may be threaded; the main components of the puncture needle are composed of a needle, a needle bar and a needle handle, and the needle may be equipped with a stab knife that can or cannot cut the skin. The structural types of puncture sleeve, puncture needle and converter are shown in Figure 1, Figure 2 and Figure 3. The specifications and basic dimensions of trocar are shown in Table 1.
Keys of index numbers:
1——Bushing;
2——Gas injection valve;
3——Sleeve socket;
4——Gas barrier valve;
5——Sheath cap (sealing element).
Figure 1 Schematic diagram of puncture sleeve structure
Keys of index numbers:
1——Needle (with stab knife);
2——Needle bar;
3——Needle handle.
Figure 2 Schematic diagram of puncture needle structure
Keys of index numbers:
1——Conversion tube;
2——Handwheel;
3——Sealing cap;
4——Holder;
5——Connecting rod;
6——Conversion seat;
7——Sealing cap.
Figure 3 Schematic diagram of converter structure
Note: The structures of puncture sleeve, puncture needle and converter shown in Figure 1 to Figure 3 are not unique.
Table 1 Basic dimensions of the trocar In: mm
4.1.2 The identification of trocar shall at least include the following elements:
Example of identification:
For the trocar with specification code of 12, inner diameter of puncture sleeve of 12.5mm and working length of puncture sleeve of 100mm, the identification is: 12×100-12.5。
4.2 Materials
Puncture sleeve, needle and needle bar shall be made of stainless steel and other materials specified in YY/T 0294.1-2016.
The trocar may also be made of other materials that are verified as safe and effective.
5 Requirements
5.1 Appearance
5.1.1 The outer surface of the trocar shall be flat and smooth, and the surface shall be free of burrs, bubbles, impurities, cracks, pores, grooves, sinter, rust and other defects.
5.1.2 There shall be no visible lubricant accumulation on the surface of the trocar.
5.1.3 The trocar shall at least have specification code, batch number, manufacturer's name (or trademark), without dislocation or skew, and the marking shall be clearly visible.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Structure and materials
5 Requirements
6 Test methods
7 Type inspection
8 Labels and instructions
9 Packaging, transportation and storage
Annex A (Normative) Test methods for gas barrier and sealing properties
Annex B (Informative) Test method for puncture property evaluation
Annex C (Informative) Test method for pullout property evaluation
