YY 0847-2011Medical endoscopes - Endotherapy device - Stone retrieval baskets (English PDF)

3.1 Wire basket

A mesh basket that is used for taking stone, foreign matter or tissue sample.

3.2 Stone retrieval forceps

An endotherapy device that works with designated endoscope, which is mainly composed of handle, slender guiding-rope and guiding-duct, and wire basket on the head. It traps the stone, foreign matter or tissue sample via wire basket's circle; and firmly catches the stone, foreign matter or tissue sample through contraction of wire basket.

3.3 Insertion portion

A part of stone retrieval forceps which can be inserted into human nature orifice, surgical incision, endoscope's device channel or endotherapy device's channel.

3.4 Maximum insertion portion width

The maximum external width of insertion portion.

3.5 Working length

The maximum length of insertion portion of stone retrieval forceps.

3.6 Endotherapy device

A medical device, which is used in endoscopic surgery, goes into human nature orifice or surgical incision through the same or different channel with endoscope, so as to realize examination, diagnosis or treatment.

Note 1. Endotherapy device includes some devices that lead the endotherapy device to insert.

It also includes some devices that are used under observation of endoscope and go from human opening which is different from the endoscope, for safety purpose.

4.1 Material used in the part of contacting with patients

4.1.1 Requirements for chemical composition

Material used in the part of contacting with patients shall be clearly indicated in any possible form by the manufacturer. Metal material shall be marked with trademark and/or code as well as the material's chemical composition requirements. Metal material's chemical composition shall be verified by experiment.

4.1.2 Biocompatibility

For material used in the part of contacting with patients, it shall conduct biological safety evaluation according to principles and requirements in GB/T 16886.1, so as to prove that it has good biocompatibility.

Biological evaluation shall consider the results of biological test. The selection of test items are conducted according to the guideline of GB/T 16886.1.

Relevant parts of GB/T 16886 are preferred for all the tests.

For material that has previously been proved as applicable, if it can prove that the following manufacturing process is insufficient to produce any biological safety hazards, then it may be exempted from repeated biological test.

Note 1. When device's material in design has demonstrable history of using in specific application OR any obtainable material's and/or device's information from other aspects, it shall be regarded that the material has been proved as applicable.

Note 2. If metal material uses medical metal material that is suitable in application scope of national or industrial standard, it may be exempted from repeated biological test.

4.1.3 Polymeric material's

dissolving precipitates in the part of contacting with patients

4.1.3.3 Heavy metal. leachables are less than 5.0 µg/mL

4.1.3.2 pH. pH difference is less than 2.0

4.1.3.1 Surface / appearance

Colorless and transparent, no foreign matter, inspected by visual inspection.

4.1.3.4 Potassium permanganate reducing substances. consumption

difference with standard test solution is less than 2.0 mL.

4.1.3.5 Evaporation residue. less than 2.0 mg

4.2 Appearance

4.2.1 Except for special purpose, there shall not have any possible safety-harm on the outer surface.

4.2.2 There is no floss, loosing, other obvious abnormalities or damage for wire

5.4 Performance tests

5.4.2 Coil the insertion portion into a circle or arc of which the radius is 10 cm; push the handle; the stone retrieval forceps shall be open and close smoothly.

5.4.3 Coil the insertion portion into a circle or arc of which the radius is 10 cm; open the stone retrieval forceps; turn the handle; the stone retrieval forceps shall rotate smoothly.

5.4.1 Tensile strength test

Apply the nominal tension, provided by the manufacturer, to the whole stone retrieval forceps. No damage or fracture on each part of stone retrieval forceps.

5.5 Tolerance tests

5.5.1 High temperature and high pressure resistance test

After 20 tests of high temperature and high pressure resistance, it shall still comply with requirements in 4.2 and 4.4.

5.5.2 Corrosion resistance test

Conduct boiling water test in YY/T 0149-2006 for the portion that uses stainless steel, according to requirements in 4.5.2. For other materials, it shall conduct once according to the sterilization method, as designated in the instructions for use by the manufacturer. There shall have no corrosion.

5.5.3 Repeated operation resistance

For operation of actual-practice simulation, it shall comply with requirements in 4.5.3.

5.6 Sterility requirement test

5.6.1 Conduct in the method specified in GB/T 14233.2-2005, according to requirements in 4.6.1.

5.6.2 Conduct in gas chromatography specified in GB/T 14233.1-2008, according to requirements in 4.6.2.

5.7 Luer fitting test

Conduct according to relevant tests in GB/T 1962.1-2001, GB/T 1962.2-2001, and requirements in 4.7. […]