YY/T 0943-2014Medical endoscopes - Endotherapy device - Needle forceps (English PDF)

3.1 Needle forceps

An endoscopic instrument for use with a designated endoscope. It is mainly composed of handle, forceps rod, forceps head. It is used to hold suture needles.

3.2 Insertion portion

A part of needle forceps. This portion can be inserted into the natural orifice of the human body or the surgical incision, or into the instrument channel of the endoscope, or the instrument channel of the endoscope accessory, or the instrument channel of the endoscope instrument.

3.5 Endotherapy device

In endoscopic surgery, for the purpose of examination, diagnosis or treatment, a medical device that enters the natural orifice or surgical incision of the human body through the same or different channel as the endoscope.

4.1 Materials used in patient contact parts

4.1.1 Requirements for chemical composition

The material used in the parts in contact with the patient shall be indicated by the manufacturer in any possible form. Among them, the metal material shall be marked with the designation and (or) code and the chemical composition requirements of the material. The chemical composition of metallic materials shall be verified by tests.

4.1.3 Dissolution extracts of polymeric materials in patient contact parts

4.1.3.1 Appearance (turbidity, color). Colorless and transparent. No foreign matter can be seen by visual inspection.

4.1.3.2 pH. Compared with the blank control solution of the same batch, the pH difference shall be less than 2.0.

4.1.4 Hardness

The forceps head shall meet the hardness requirements specified by the manufacturer.

4.1.5 Surface and internal material consistency

The manufacturer shall claim that the surface of the part of the device made of metal material is consistent with the internal material. If it is really necessary to coat the surface of the device, the manufacturer shall give the corresponding coating requirements and test methods.

4.2 Appearance

4.2.1 Under the endoscopic field of view, the visible tip portion of the surgical instrument shall be treated, so as to eliminate possible directional reflections.

4.2.2 Except for special purposes, the outer surface shall not have burrs and other defects that may cause injury.

4.2.3 The locking teeth on the locking mechanism of the needle forceps shall be complete.

4.3 Size

4.3.1 Maximum insertion portion width

The manufacturer shall give the nominal value of the maximum insertion portion width in the instructions for use.

4.4.1 Opening-closing performance

The forceps heads shall open and close smoothly. When the forceps rods are opened and closed, there shall be no shaking that interferes with the user's use.

4.4.2 Clamping force

There shall be a certain clamping force.

4.4.5 Rotation performance (for needle forceps with rotation function)

Rotation shall be smooth. When the forceps rods are rotated, there must be no shaking that interferes with the user's use.

4.5 Resistance (for non-single-use products)

4.5.1 High-temperature and high-pressure resistance

After 20 high-temperature and high-pressure tests of needle forceps marked as high- temperature and high-pressure resistance, they shall still meet the requirements of 4.4.

4.6 Sterilization requirements (for single-use products)

4.6.1 Needle forceps shall be sterile.

4.6.2 Residual amount of ethylene oxide (applicable to products sterilized by ethylene oxide) Residual concentration of ethylene oxide. 10µg/g or less.

4.7 Luer connector (for needle forceps with injection port)

It shall meet the relevant requirements of GB/T 1962.

4.8 Instructions for use

4.8.1 It shall contain clear instructions for the suture needles, endoscopes and 4.8.3 Product specifications shall be included.

4.8.4 A statement of the intended use of the product shall be included.

4.8.5 Instructions for preparation, inspection and operation when using the product shall be included.

4.8.7 If the needle forceps are not single-use products, the instructions for use shall include details on the methods of cleaning, disinfection or sterilization that can be used.

Prescribe suitable disinfectants when necessary. List the temperature, pressure, humidity, and time limits to which these equipment components can withstand.

4.8.8 Operation, transportation and storage environmental restrictions. The allowable environmental conditions for operation, transportation and storage shall be specified.

4.9 Labelling

There shall be clearly legible and permanently affixed formal marks, the name and/or trademark of the manufacturer or supplier on the product.

5.1 Material test

5.1.1 Chemical composition test

The chemical composition analysis test of metal materials shall be carried out by a method whose accuracy is equal to or better than 1/3 of the tolerance or limit value.

5.1.4 Hardness test

Carry out the test according to the method specified in GB/T 4340.1-2009.Measure 3 points on each of the 2 pieces of the forceps head. Take the arithmetic mean of every 3 points.

5.1.5 Consistency inspection of surface and interior materials

Visually inspect. For products with a coating on the surface of the device, follow the corresponding test method provided by the manufacturer.

5.2 Appearance

5.2.1 Imitate the actual operation. Visually inspect.

5.3 Size

5.3.1 Inspection of maximum insertion portion width

Use a universal measuring tool to inspect.

5.3.2 Inspection of working length

Use a universal measuring tool to inspect.

5.3.3 Inspection of maximum opening range of forceps head

Use a universal measuring tool to inspect.

5.4.1 Opening-closing test

Imitate the actual operation. Visually inspect.

5.4.6 Anti-deformation test

Lock the needle forceps in the maximum lock state. Hold a straight round needle that complies with YY 0043-2005.Keep this state for 10min. The temperature is room temperature. Check whether the suture needle is damaged or deformed.

5.4.7 Forceps head tooth test

Use a 10x magnifying glass to observe the alignment.

5.5 Resistance tests

5.5.1 High-temperature and high-pressure resistance test

After repeating the test for 20 times according to the high-temperature and high- pressure resistance test method specified by the manufacturer, carry out the test according to the method of 5.4.

5.5.2 Corrosion resistance test

The martensitic and austenitic stainless-steel materials are partly tested according to the boiling water test method in YY/T 0149-2006.The rest materials are sterilized once as specified by the manufacturer in the instructions for use.

5.6 Sterilization requirements test

5.6.1 Sterilization test

Carry out according to the method specified in GB/T 14233.2.The test solution preparation method may be specified by the manufacturer if not applicable.

5.7 Luer joint test

Carry out according to the relevant test in GB/T 1962.

5.8 Inspection of instructions for use

Check the contents of the instructions for use provided by the manufacturer.

5.9 Inspection of marks and labels

Visually inspect the mark and label on the product.

5.10 Water/ventilation performance

Carry out according to the test method specified by the manufacturer.