YY/T 1710-2020 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1710-2020 | English | 245 |
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YY/T 1710-2020: Disposable Abdominal Trocars---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1710-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.30
C 31
Disposable Abdominal Trocars
Issued on. FEBRUARY 26, 2020
Implemented on. MARCH 1, 2021
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Structure and Materials... 5
4 Requirements... 7
5 Test Methods... 10
6 Type Inspection... 13
7 Labeling and Instruction Manual... 13
8 Packaging... 14
Appendix A (normative) Test Method for Air Chocking and Sealing Performance
... 15
Appendix B (informative) Evaluation and Test Method for Puncturing
Performance... 17
Appendix C (informative) Evaluation and Test Method for Plugging / Unplugging
Performance... 19
Foreword
This Standard was drafted in accordance with the rules provided in GB/T 1.1-2009.
Please be noted that certain content of this document might involve patents. The
institution issuing this document shall not undertake the responsibility of identifying
these patents.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical Committee 94 on
Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94).
The drafting organizations of this Standard. Jiangsu Sinolinks Medical Device Co., Ltd.;
Shanghai Medical Device Testing Institute; Anhui Aofo Medical Equipment Tech
Corporation; Beijing Institute of Medical Device Testing; Shandong Weray Surgical
Products Co., Ltd.; Jiangsu Institute of Medical Device Testing.
The main drafters of this Standard. Yang Kaiming, Wang Zewei, Duan Yu, Hu
Guangyong, Yao Daqiang, Shi Zhigang, Chen Li, Weng Binghao, Yang Zhiyuan, Geng
Xin, Ma Bo, Wang Yue.
Disposable Abdominal Trocars
1 Scope
This Standard specifies the structure, materials, requirements, test methods, type
inspection, labeling, instruction manual and packaging of disposable abdominal trocars.
This Standard is applicable to disposable abdominal trocars (hereinafter referred to as
trocars) that puncture human abdominal wall tissues during laparoscopic surgery to
establish artificial pneumoperitoneum and operate surgical instrument channel.
2 Normative References
The following documents are indispensable to the application of this document. In
terms of references with a specified date, only versions with a specified date are
applicable to this document. In terms of references without a specified date, the latest
version (including all the modifications) is applicable to this document.
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 Equipment 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
3 Structure and Materials
3.1 Structure and Marking
3.1.2 The marking of the trocars shall at least include the following elements. See the
marking below.
Example of marking.
Trocars with specification code. 12; inner diameter of puncturing sleeve casing. 12.5 mm;
working length of puncturing sleeve casing. 100 mm, shall be marked as. 12 100-12.5.
3.2 Materials
The main components of the trocars are made of the following materials.
4 Requirements
4.1 Appearance
4.1.1 The outer surface of the trocars shall be smooth and clean. There shall be no
defects, such as. burrs, bubbles, impurities, cracks and sintered substances, etc.
4.1.2 The surface of the trocars shall not have visible accumulation of lubricant.
4.1.3 The specification marking on the body of the trocars shall be clearly visible.
4.2 Dimensions
The inner diameter and working length L of the puncturing sleeve casing of the
trocars shall comply with the stipulations of Table 1.
4.3 Surface Roughness
If there is a puncturing knife at the tip of the puncturing lever, then, the surface
roughness of the cutting edge surface of the puncturing knife Ra ≤ 0.8 μm.
4.5 Flexibility
4.5.1 The air injection valve of the trocars shall be able to be flexibly opened and closed;
there shall be no obstruction or jamming.
4.6 Coordination Performance
4.6.1 The puncturing sleeve and the puncturing lever shall properly coordinate with
each other. There shall be no jamming when plugging or unplugging.
4.7 Firmness of Connection
4.8 Air Chocking and Sealing Performance
4.8.1 The trocars shall have good air chocking performance. Through 4 kPa air
pressure, the number of outcoming bubbles shall be less than 20.
4.8.2 The trocars shall have good sealing performance. Through 4 kPa air pressure,
there shall be no leakage.
4.12 Sterility
The trocars shall be sterilized by an already confirmed sterilization process. After
sterilization, the trocars shall be sterile.
4.13 Residual Ethylene Oxide
If the trocars are sterilized with ethylene oxide, the residual amount of ethylene oxide
shall be not greater than 10 μg/g.
4.14 Dissolved Precipitates of Polymer Materials of Parts in Contact with
Patient
4.14.1 Appearance (turbidity and color)
The dissolution liquid shall be colorless and transparent, and there shall be no visible
foreign objects.
4.14.5 Evaporation residue
The total dry residue of the dissolution liquid shall be ≤ 2.0 mg.
4.15 Package Marking and Instruction Manual
4.15.1 The single package of the trocars shall have a marking that complies with the
stipulations of 3.1.2.
4.16 Biological Evaluation
The trocars shall receive biological evaluation in accordance with the stipulations of
the series standards of GB/T 16886, and there shall be no biocompatibility hazards.
5 Test Methods
5.1 Appearance
Adopt normal or corrected vision observation and hand touching to conduct the
inspection. It shall comply with the stipulations of 4.1.
5.4 Hardness
In accordance with the method specified in GB/T 4340.1, conduct the test. On the
puncturing knife, test 3 points; take the arithmetic mean value. It shall comply with the
stipulations of 4.4.
5.5 Flexibility Test
5.5.1 Imitate the action of use; check by hand feeling. It shall comply with the
stipulations of 4.5.1 and 4.5.2.
5.6 Coordination Test
5.6.1 Imitate the action of use. Plug and unplug the puncturing lever in the puncturing
sleeve for 3 times. It shall comply with the stipulations of 4.6.1.
5.6.2 Use a 0.30 mm cleansing pin to detect along the port of the casing of the
puncturing sleeve for one circle, so as to observe whether the cleansing pin can be
inserted into the fit clearance. It shall comply with the stipulations of 4.6.2.
5.7 Connection Firmness Test
5.7.1 At the junction of the detachable sheath cap and the puncturing sleeve, apply an
axial static tensile force of 50 N to any component consecutively for 10 s. It shall comply
with the stipulations of 4.7.1.
5.8 Air Chocking and Sealing Performance Test
The test method is shown in Appendix A. It shall comply with the stipulations of 4.8.
5.9 Connector of Air Injection Valve
The Luer locking connecting of the air injection valve shall be tested in accordance
with GB/T 1962.2.It shall comply with the stipulations of 4.9.
5.14 Test Method for Dissolved Precipitates of Polymer Materials of Parts
in Contact with Patient
5.14.1 Preparation of test solution
Take the sample. In accordance with the ratio of 0.2 g of sample with 1 mL of test water
(Grade-2 water that complies with the stipulations of GB/T 6682-2008), prepare it.
Then, place it in a glass container. At 37 °C ± 1 °C, conduct constant-temperature
extraction for 24 h. Separate the sample and the liquid; cool it down to room
temperature; use it as the test solution.
Take the same volume of test water, place it in a glass container. Use the same method
to prepare the blank control solution.
5.15 Package Marking and Instruction Manual
Conduct visual observation. It shall comply with the stipulations of 4.15.
5.16 Biological Evaluation
The trocars shall receive biological evaluation in accordance with the stipulations of
the series standards of GB/T 16886.It shall comply with the stipulations of 4.16.
6 Type Inspection
The type inspection items and determination principles of the trocars are shown in
Table 2.
7 Labeling and Instruction Manual
7.1 Labeling
The labeling of the trocars shall at least have the following contents or symbols.
7.2 Instruction Manual
The instruction manual of the trocars shall at least include the following contents.
8 Packaging
8.1 The minimum sales package of the trocars shall be accompanied by an instruction
manual, a quality certificate or product certificate.
8.2 The product shall be packed in a package compatible with the sterilization method.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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