JY/T 0165-2011Ear model (English PDF)

3.1 Naming rules

The model name of the product is JY 0026-1991.

3.2 Nomenclature

Ear anatomical model named.

SM - EJP-CR - 300

Product outline length 300mm Product Feature Code, Adult Product name Pinyin prefix, "ear anatomy" Product model classification code, biological model Model example.

SM-EJP-CR-300 represents a biological model, an anatomical model of an ear, an adult, and the overall length is 300mm.

4.1 Use environmental conditions

Temperature. -10 °C ~ 40 °C, relative humidity. not more than 90%.

4.2 Anatomy

4.2.1 General requirements

4.2.1.1 The product shall be an enlarged adult ear anatomical model with a length (the long axis of the pyramid of the temporal bone rock part) of 300 mm ± 20 mm, fixed on the base.

4.2.1.2 The model as a whole shall be the external ear and the connected temporal bone rock parts. The anterior half of the external ear canal is excised to show the external ear canal.

4.2.1.3 Cut part of the temporal bone rock horizontally, retain the tympanic cap, and show the middle ear and inner ear.

4.2.1.4 The long axis of the pyramid of the temporal bone and the squamous surface of the temporal bone constitute anterior 50° ± 5 ° and posterior 130°.

4.2.1.5 shows the internal carotid artery and internal jugular vein stump.

4.2.1.6 The shape, position, proportion and color of each part shall be correct and natural.

4.2.2 Specific requirements

4.2.2.1 External ear. The auricle, external ear canal, and eardrum shall be shown.

4.2.2.1.1 Auricle. its form shall be shown.

4.2.2.1.2 External auditory canal. The external auditory canal should be S-shaped, long (rear wall) 90mm ± 10mm, outer 1/3 is cartilage, and inner 1/3 is bone unit.

4.2.2.1.3 Drum membrane. it shall be a translucent off-white membrane with a long diameter of 40mm ± 2mm, a short diameter of 35mm ± 2mm, a thickness of 1mm ± 0.5mm, the membrane should be inclined forward and outward, and the outer side of the membrane should be 45° to 50° from the base of the external auditory meatus; the tympanic membrane should be able to distinguish slack, tension, hammer marks and light Cone and so on. The morphology and structure of tympanic muscles should be correct.

4.2.2.2 Middle ear. The tympanic cavity, eustachian tube, mastoid sinus, and mastoid atrium shall be shown.

4.2.2.2.1 Tympanic chamber. It should be located between the tympanic membrane and the outer wall of the inner ear. It is an irregular cavity with six walls, namely the upper wall, the lower wall, the front wall, the posterior wall, medial wall and lateral wall show the three auditory bones in the tympanum. the malleus, anvil and sacrum. The three auditory bones should have a clear outline and accurate structure.

The malleus is attached to the inner surface of the tympanic membrane and ends at the umbilical cord. The base of the sacrum should coincide with the edge of the vestibular window, and the seam should not exceed lmm (three ossicles can be removed with the eardrum). The inner wall of the tympanic chamber should show the headland, vestibular window, worm window, and facial nerve canal. The posterior wall should show the mastoid sinus ostium.

4.2.2.2.2 Eustachian tube. It should be shown that it opens in the anterior wall of the tympanic cavity and shows the tympanic muscles above the tube wall.

4.2.2.2.3 Mastoid sinus and mastoid atrium. The mastoid sinus should be located behind the crypt in the upper tympanum and open at the upper part of the posterior wall of the tympanum (the mastoid sinus).

Mastoid atria are small cavities of varying size and shape within the temporal bone, and their structural features should be displayed correctly.

4.2.2.3 Inner ear (removable). The vestibule, the semicircular canal, and the cochlea should be shown.

4.2.2.3.1 Vestibular. It should be located in the middle of the inner ear, and its outer wall (ie, the inner wall of the tympanic cavity) vestibular window (oval hole) and worm window (round hole).

4.2.2.3.2 Bone semicircular canals. The three bone semicircular canals should be located on three planes perpendicular to each other. The position of the external canal semicircular canal is consistent with the horizontal plane, the plane of the anterior canal canal is perpendicular to the long axis of the cone, and the plane of the posterior canal canal is parallel to the long axis of the cone. Bone semicircular canal should be displayed correctly Abdominal, single and total bone feet.

4.2.2.3.3 Cochlea. It should be correctly shown that the spiral tube rotates around the worm axis by 21/2 ~ 23/4.

4.2.2.4 The vestibular cochlear nerve should enter and exit from the inner ear portal.

4.2.2.5 The following parts of the model shall be affixed with name or number tags. external ear canal, tympanic membrane, auditory ossicle, tympanic cavity, eustachian tube, tympanic muscle, mastoid sinus Vestibular, bony semicircular canal, cochlea, vestibular window, worm window, vestibular cochlear nerve.

4.3 Materials and processes

4.3.1 The model should be made of rigid PVC material, and glass fiber reinforced plastic (FRP) or fragile and deformable materials should not be used.

4.3.2 The content of heavy metals in the coating of the model shall conform to GB 5.2.5.4 of GB 21746-2008.

4.3.3 The structure of each part indicated on the model should be accurate, the joints should be natural and flat, and the bonding or splicing should be firm.

4.3.4 The color of the structure of each part should be correct and clear, and the spraying transition should be natural and there should be no spillage.

4.3.5 The product shall also comply with JY 0001-2003 sections 5.2, 6.9, 6.12, 6.27, 7.4.3, 7.7 and 9.1 to 9.6.

4.4 Environmental test

4.4.1 The product shall be tested for temperature, humidity, and free drop in accordance with JY 0213-1994 Section 3.1, and shall be subjected to a drop test in an unpackaged state.

4.4.2 The drop height of the drop test in the non-packaging state is 1m. The drop surface shall be the largest surface of the model outline. After the test, it shall not be broken or cracked.

If there is a stand, it should not be included.

5.1 Relevant dimensions

Measured with a steel ruler with a division value of 1 mm.

5.2 Anatomy, appearance and workmanship

Sensory test.

5.3 Environmental test

5.3.1 Temperature, humidity and free fall test According to JY 0213-1994 Section 4.1, 4.2, 4.6.

5.3.2 Drop test in unpacked state. Lay a wooden board with a thickness of 20mm ± 3mm on the cement floor, and keep the board rigidly connected to the cement floor touch. During the test, the model's falling surface is downward, and it will fall freely from a height of 1m. Once tested, it shall meet 4.4.2.

6.1 Inspection classification

Product inspection is divided into factory inspection, type inspection and quality supervision inspection.

6.2 Inspection items

The inspection items and methods of factory inspection and type inspection are shown in Table 1.

Table 1 Inspection items and methods of factory inspection and type inspection

6.3 Sampling method

Item No. Inspection Item Standard Provisions Factory Inspection Type Inspection

1 General requirements 4.2.1 -

2 Specific requirements 4.2.2 -

3 Materials and processes 4.3 -

4 Environmental test 4.4--Note. "-" in the table means all inspection items, and "-" means no inspection items.

6.3.1 The factory inspection shall be batched according to the natural batch of delivery, and the type inspection shall be batched according to the stock array.

6.3.2 During the factory inspection, all the inspection items shall be inspected first, and the sampling inspection items shall be inspected among the qualified products.

6.3.3 The samples for type inspection shall be taken from the products that passed the factory inspection.

6.3.4 The sampling methods for factory inspection and type inspection shall be in accordance with JY 0002.

6.4 Non-conformance determination

6.4.1 The judgment of sampling inspection shall be in accordance with JY 0002.

6.4.2 The failure criterion of a single sample shall be in accordance with JY 0002.

6.4.3 The factory inspection shall be determined according to the unqualified criterion of a single sample.

6.4.4 4.2 of this standard (except for slight defects in the color and spray transition or slight inaccuracy in the spray transition), 4.3.1, 4.3.2 and 4.3.3 is the main performance indicator.

6.5 Review rules

6.5.1 Unqualified products can be submitted for inspection again after rework.

6.5.2 If the cause of the batch failure is a sampling inspection item, the item shall be changed to a full inspection during the re-inspection.

6.6 Quality supervision inspection

Quality supervision and inspection shall be in accordance with JY 0002.