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YY/T 1472.1-2016 English PDF (YYT1472.1-2016)

YY/T 1472.1-2016 English PDF (YYT1472.1-2016)

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YY/T 1472.1-2016: Thoracic minimally invasive instruments. Part 1: Dual pivot surgical clamps

This part of YY/T 1472 specifies the product classification, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation, and storage requirements for dual pivot surgical clamps. This part applies to dual pivot surgical clamps (hereinafter referred to as clamps) for use in thoracic minimally invasive surgery: -- minimally invasive tissue clamps, used to clamp tissues and organs, such as lung lobes and lymph nodes; -- minimally invasive separating and ligation clamps, used to separate target organs, such as blood vessels and tissues; -- minimally invasive vascular clamps, used to clamp and block blood vessels; -- minimally invasive needle-holding pliers, used to hold suture needles.
YY/T 1472.1-2016
YY
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.040.30
C 36
Thoracic minimally invasive instruments - Part 1: Dual
pivot surgical clamps
ISSUED ON: JANUARY 26, 2016
IMPLEMENTED ON: JANUARY 1, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 6
2 Normative references ... 6
3 Product categories ... 7
4 Requirements ... 12
5 Test methods ... 14
6 Marking and instructions for use ... 17
7 Packaging, transportation, and storage ... 17
Appendix A (Normative) Clamping performance test for vascular clamps ... 19 Appendix B (Normative) Clamping and blocking performance test for vascular clamps ... 20
Thoracic minimally invasive instruments - Part 1: Dual
pivot surgical clamps
1 Scope
This part of YY/T 1472 specifies the product classification, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation, and storage requirements for dual pivot surgical clamps.
This part applies to dual pivot surgical clamps (hereinafter referred to as clamps) for use in thoracic minimally invasive surgery:
-- minimally invasive tissue clamps, used to clamp tissues and organs, such as lung lobes and lymph nodes;
-- minimally invasive separating and ligation clamps, used to separate target organs, such as blood vessels and tissues;
-- minimally invasive vascular clamps, used to clamp and block blood vessels; -- minimally invasive needle-holding pliers, used to hold suture needles. 2 Normative references
The following documents are essential to the application of this document. For the dated referenced documents, only the versions with the indicated dates are applicable to this document; for the undated referenced documents, only the latest version (including all the amendments) is applicable to this document.
GB/T 4237-2015 Hot rolled stainless steel plate, sheet and strip
GB/T 4240-2009 Stainless steel wires
GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method GB 7543-2006 Single-use sterile rubber surgical gloves
GB/T 8938-2008 Typewriting paper
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB 19790.2-2005 Disposable chopsticks - Part 2: Bamboo chopsticks
BB/T 0014-2011 Grip bag
YY/T 0031-2008 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance
YY 0167-2005 Non-absorbable surgical suture
YY/T 0173.4-2005 Surgical instruments - Teeth, serration, ratchet and elliptoid ring
YY/T 1052-2004 Marking requirements for surgical instrument
3 Product categories
3.1 Structural type
3.1.1 Clamps include minimally invasive tissue clamps, minimally invasive separating and ligation clamps, minimally invasive vascular clamps, and minimally invasive needle-holding pliers (hereinafter referred to as tissue clamps, separating and ligation clamps, vascular clamps, and needle-holding pliers).
3.1.2 An example of a clamp structure mainly consists of a clamp head, a sliding rod, a fixed rod, a handle, a gill shaft of the handle joint, and a gill shaft of the clamp head joint. The handles have two types: the ring handle (with or without locking teeth) and the spring handle (with locking teeth), see Figure 1. The clamp heads can be made into straight, curved, or 90?? bent shapes, see Figure 2. The working surface of the clamps can be made in the form of toothless, toothed, or reticulated teeth, see Table 1. The structure of clamps can also be designed and formulated by the manufacturer. 4 Requirements
4.1 Hardness
4.1.1 For clamps made of stainless steel and heat-treated material, the hardness shall be 376 HV0.2~480 HV0.2, and the difference in hardness between the two pieces shall not be greater than 40 HV0.2.
4.1.2 If clamp heads of needle-holding pliers are equipped with carbide inserts, the hardness shall not be less than 923 HV0.5, and the difference in hardness between the two pieces shall not be greater than 50 HV0.5.
4.2 Matching performance
Clamps shall have good matching performance:
a) The working surfaces without teeth shall match, and the working surfaces with 60?? teeth shall engage (occlude).
b) After working surfaces with the single-tooth, double teeth, (1??2) teeth, and (2??3) teeth engage (occlude), the test material shall have clear marks and no damage.
c) When the locking teeth of the clamps with reticulated teeth come into contact, the front ends of the working surfaces shall touch; when the locking teeth are all locked, the working surfaces shall match.
4.3 Clamping performance
4.3.1 Tissue clamps, separating and ligation clamps, and needle-holding pliers shall have good clamping performance, and there shall be no slippage when test materials are clamped.
4.3.2 The vascular clamps shall have good clamping performance, and the clamping force shall be ???250 g.
4.3.3 The vascular clamps shall have good blocking performance and shall be able to block the flow of water at a pressure of 26 kPa.
4.4 Sliding performance
The sliding rod and fixed rod of the clamps shall slide smoothly without any obstruction. 4.5 Opening and closing flexibility
4.5.1 The clamps shall be opened and closed easily and flexibly, and there shall be no lag or jamming in movement transmission.
4.5.2 The gill shaft of the handle joint and the gill shaft of the clamp head joint shall be firm, and the gill shaft shall not move when the clamp is opened or closed. 4.6 Strength and robustness
4.6.1 Clamps shall have good strength properties:
a) The body of the clamps has no cracks or permanent deformation;
b) There is no breakage in the gill shaft of the handle joint and the gill shaft of the clamp head joint.
4.6.2 The matching and clamping performance of the clamps shall remain unchanged after the strength test and shall comply with the requirements of 4.2 and 4.3. 4.6.3 If the clamp heads of the needle-holding pliers are equipped with carbide inserts, the connection between the inserts and the base body shall be firm.
4.7 Dimensions
The maximum opening ?? of the clamp head, the working length l, and the rod width b shall comply with the nominal values specified by the manufacturer, and their tolerances shall comply with the provisions of Table 2.
4.8 Appearance
4.8.1 The head end of the clamps shall be rounded, and the appearance shall be flat and smooth, without sharp edges, burrs, or cracks; the working surface shall comply with the requirements of Table 1 and Table 2, and its form and locking teeth shall be clear and complete.
4.8.2 The handles of needle-holding pliers with carbide inserts shall be golden yellow. The handles of needle-holding pliers without carbide inserts shall not be golden yellow. 4.9 Surface roughness
The outer surface roughness Ra of the clamps shall not be greater than 0.8 ??m. 4.10 Corrosion resistance
The corrosion resistance of the outer surface of the clamps shall not be lower than the requirements of level 5.4b in YY/T 0149-2006.
4.11 Biocompatibility
According to the regulations of GB/T 16886.1-2011, the manufacturer shall formulate 5.3.1 Clamps are tested as follows and shall comply with the provisions of 4.3.1: a) For tissue clamps, use the front end of the clamp to clamp the edge of the 32 cm??20 cm snap-type grip bag specified in BB/T 0014-2011, rotate the clamp to flip the grip bag placed horizontally on the operating platform side to side, repeat 3 times:
1) if the clamp is toothed, fill the grip bag with 1000 mL of water;
2) if the clamp is toothless, fill the grip bag with 500 mL of water.
b) For separating the ligation clamps, clamp a No. 8 natural rubber latex glove specified in GB 7543-2006 with a 500 g weight in it at 1/3 position from the front end of the clamp head, and let the glove hang down naturally for 10 seconds.
c) For needle-holding clamps, clamp a 3-0 Class I uncoated surgical suture specified in YY 0167-2005 at 1/3 position from the front end of the clamp head, pull the suture broken, and observe the clamped suture.
5.3.2 The clamping performance of the vascular clamps shall be tested according to the test method in Appendix A and shall comply with the provisions of 4.3.2. 5.3.3 The blocking performance of the vascular clamps shall be tested according to the test method in Appendix B and shall comply with the provisions of 4.3.3. 5.4 Sliding performance
Imitate the working operation, feel it, and check the clamp with normal or corrected vision; it shall comply with the provisions of 4.4.
5.5 Opening and closing flexibility
Imitate the working operation, feel it, and check the clamp with normal or corrected vision; it shall comply with the provisions of 4.5.1 and 4.5.2.
5.6 Strength performance and robustness
5.6.1 According to the provisions of Table 4, place the selected test material at the specified placement position, close the clamp (for 10 seconds), and then release it; repeat three times; the test result shall comply with the provisions of 4.6.1. 6 Marking and instructions for use
6.1 Marking
6.1.1 Each clamp shall have at least the following markings according to the provisions of YY/T 1052-2004:
a) Manufacturer's code or trademark;
b) Material marking.
6.1.2 The packaging (minimum sales unit) shall have at least the following markings: a) Manufacturer's name or trademark, and factory address;
b) Product name (marked according to 3.4);
c) Specifications and models (marked according to 3.4);
d) Quantity;
e) Production date and expiration time;
f) Production license number (production filing certificate number);
g) Number of the Registration Certificate for Medical Device (filing certificate number).
6.2 Instructions for use
Instructions for use shall be prepared in accordance with medical device instructions and label management regulations, and shall also include a description of the material surface treatment method.
7 Packaging, transportation, and storage
7.1 Packaging
The clamps are packaged after anti-rust treatment (multiple clamps shall be separated), and the packaging (minimum sales unit) shall be accompanied by instructions for use and certification documents.
7.2 Transportation and storage
7.2.1 Under the conditions specified by the manufacturer, the outer packaging of the clamps shall not be damaged during transportation.

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