YY/T 0842-2011Medical endoscopes—Endoscope accessories—Sheaths (English PDF)

3.1 Endoscope accessory

Optional accessories that are necessary and/or suitable to be used with endoscopes, to achieve the intended use of endoscopes, or to provide convenience for the intended use of endoscopes, or to improve the intended use of endoscopes, or to increase the additional use of endoscopes.

3.2 Sheath

External inserting pipes for guiding endoscopes or endotherapy devices.

3.3 Main channel

A part of sheaths. Endoscopes or endotherapy devices are required to be inserted through this part.

3.4 Minimum main channel width

Minimum internal width of the channel of endoscopes or endotherapy devices.

3.5 Insertion portion

A part of sheaths, which can be inserted into natural channels or surgical incisions of human bodies.

3.5.1 Working length

Maximum length of sheath's insertion portion.

4.1 Materials

4.1.1 Chemical composition of metal materials

Manufacturers of the metal materials that directly or indirectly contact with patients shall explicitly indicate in any possible form, wherein the metal materials shall be marked with grades and/or code as well as the requirements for materials' chemical composition. The chemical composition of metal materials shall be verified by tests.

4.1.2 Biological compatibility

Materials that directly or indirectly contact with patients shall be conducted with biological safety evaluation in accordance with the principles and requirements in GB/T Sheaths and endoscopes or scope mounts or obturators shall meet the following requirements after mounting.

a) the positioning shall be reliable and has no loosening after full insertion;

b) except for no sealing requirement claimed by the manufacturer, the sealing after full insertion shall be in a good condition. The water seeped shall not exceed more than 5 drops within 1 min when performing water permeability test.

4.4 Connection

Every connecting portion involving sheaths shall be connected by tight mounting method, the mounting area shall be no visible cracks; if it is connected by welding, the welding seam shall be no unevenness, loose weld, bead weld or apparent pitting; if it is connected by gluing, the gluing area shall be no effusion or apparent heaping glue, other parts shall be no flow trance of glue.

4.5 Outer surface quality of insertion portion

Except for special purpose, there shall be nothing that may cause injury on the insertion portion.

4.6 Water-passing and/or air-passing functions

4.6.1 Water-passing and/or air-passing ducts

If the sheath has water-passing and/or air-passing functions, there shall be no impurities in water-passing and/or air-passing ducts, and water-passing and/or air-passing processes shall be smooth.

4.6.2 Water-passing and/or air-passing connectors

If the sheath has water-passing and/or air-passing functions, the manufacturer shall provide the specification of water-passing and/or air-passing connectors. Water-passing and/or air-passing connectors of sheath shall meet the requirements of this specification or relevant standards applicable for this specification.

4.7 Tolerance (applicable for non-disposable products)

After the following tolerance tests, the sheath shall still be able to meet the requirements of 4.3.

a) High-pressure and high-temperature resistance Sheaths with high-pressure and high-temperature resistance shall be able to […]

5.6 Water-passing and/or air-passing functions

5.6.1 Water-passing and/or air-passing ducts

VERIFY by visual observation and water-passing and air-passing operations.

5.6.2 Water-passing and/or air-passing connectors

MEASURE according to the method specified in the relevant standards applicable for connector specification.

5.7 Tolerance test

5.7.1 High-temperature and high-pressure resistance test

After performing 20 times of high-temperature and high-pressure resistance test (the test conditions are in accordance with the specification in manufacturer's instruction manual), the result shall still meet the requirements of 4.3.

5.7.2 Corrosion resistance test

The portion uses stainless steel material shall be tested according to the boiling water test method in YY/T 0149-2006, the result shall meet the requirements of 4.7 b). Other materials shall be processed according to the sterilization method specified by the manufacturer in the instruction manual, there shall be no corrosion, and the result shall still meet the requirements of 4.3.