YY 0336-2020Sterile vaginal dilator for single use (English PDF)

3.1 The structure of the expander

The expander is mainly composed of upper and lower lobes (including handles). According to the way it is opened, its main structural types include pivot type and push-pull type, such as As shown in Figure 1 and Figure 2, if it can meet the requirements of this standard, other structural types can also be used.

4.1 Appearance

The surface of the expander should be smooth and free of impurities. The upper and lower lobes of the expander should have smooth arcs, no sharp edges, and no burrs, and the handle should have no sharp edges, No glitches. When the upper and lower lobes of the dilator are closed, the contact surface to the outer edge should be smooth.

4.2 Dimensions

4.2.1 When the expander is in the natural closed state, the upper and lower lobes should be basically anastomosed, and the upper and lower lobes' head and left and right deviations should be no more than 2mm.

4.3 Performance

4.3.1 The adjustment of each gear of the expander should be flexible, and there should be no jamming.

4.3.2 The gears of the expander should be stable and should not slip, fall off or break.

4.3.3 In any working state, no part of the expander should block the view port.

4.4 Physical properties

4.4.1 Anti-deformation ability

When the expander is expanded to the maximum stop, a force of 20N is applied, and the allowable amount of deformation should not exceed 30mm.

4.4.2 Structural strength

When the expander expands to the maximum stop, apply a force of 30N, and any part should not slip off, crack or break.

4.5 Sterile

The dilator should be sterilized by a confirmed sterilization process, and the dilator after sterilization should be sterile.

4.6 Residual amount of ethylene oxide

If the expander is sterilized with ethylene oxide, the residual amount of ethylene oxide should not exceed 10µg/g.

4.7 Biological evaluation

4.7.1 Cytotoxicity

The cytotoxicity reaction should not be greater than level 1.

4.7.2 Delayed type hypersensitivity

There should be no delayed hypersensitivity.

4.7.3 Irritation test of vaginal mucosa

The average score of the stimulus index should not be greater than 4.

5.1 Appearance

Check with visual observation and hand touching, and it should meet the requirements of 4.1.

5.2 Dimensions

5.2.1 Keep the expander in a natural closed state and measure it with a general or special measuring tool, which should meet the requirements of 4.2.1.

5.2.2 Use general-purpose or special-purpose measuring tools to measure, which should meet the requirements of 4.2.2.

5.2.3 Expand the expander to the maximum stop, set the rear end of the field of view to be vertical, and measure with a general or special measuring tool. The central axis of the outer surface of the upper lobe The vertical distance between the lowest point of the lower leaf and the intersection of the central axis of the outer surface of the lower leaf and the arc on the handle shall meet the requirements of 4.2.3.

5.3 Performance

5.3.1 Apply a force of 20N at a distance of 20mm from the front end of the upper lobe, and the expander should be in compliance with the requirements of 4.3.1 and 4.3.2 from closing and opening to all gears. Regulations.

5.3.2 Place the expander at any working position, the bottom of the field of view in the line of sight coincides with the bottom of the lower lobe, and observe visually, the result should be consistent with […]

5.4 Physical properties

5.4.1 Anti-deformation ability

According to the test method in Appendix A, apply a force to 20N for (5 ± 1) s, which should meet the requirements of 4.4.1.

5.4.2 Structural strength

According to the test method in Appendix A, apply the force to 30N for 1min, which should meet the requirements of 4.4.2.

5.5 Sterile

The test is carried out in accordance with the sterility inspection method stipulated in the Pharmacopoeia of the People's Republic of China, and shall meet the requirements of 4.5.

Note. Each sterilization batch is sterilized by a confirmed effective sterilization process, so that the product can achieve aseptic effect.

5.6 Residual amount of ethylene oxide

According to GB/T 14233.1-2008 specified in Chapter 9 or Chapter 10, the test should meet the requirements of 4.6.

Note. Gas chromatography is used in arbitration.

5.7 Biological evaluation

5.7.1 The test is carried out in accordance with the extract test method in GB/T 16886.5, which shall meet the requirements of 4.7.1.

5.7.2 Test according to the method in GB/T 16886.10, which should meet the requirements of 4.7.2.

5.7.3 Test according to the method in GB/T 16886.10, which should meet the requirements of 4.7.3.

6.1 Acceptance

The expander should be inspected by the quality inspection department of the manufacturer, and only after it is qualified can it be submitted for acceptance.

6.2 Inspection method

Expanders should be submitted for inspection in batches, which are divided into batch-by-batch inspection (factory inspection) and periodic inspection (type inspection).

6.3 Batch inspection

6.3.1 The batch-by-batch inspection shall be carried out in accordance with the regulations in GB/T 2828.

6.3.2 The sampling plan adopts one-time sampling. The strictness of the sampling plan starts from the normal inspection sampling plan. The unqualified classification group and inspection items The items, inspection level and acceptance quality limit (AQL) shall be in accordance with the provisions of Table 3 (calculated based on the number of unqualified products per hundred units).

6.4 Periodic inspection

6.4.1 Periodic inspection should be carried out in the following cases.

a) Before the new product is put into production (including the transfer of the old product to factory production);

b) When it is put into production after more than one year interval;

c) When there are major changes in product design, technology or materials;

d) Continuously produced products once a year;

e) When requested by the National Quality Supervision and Inspection Department.

6.4.2 Periodic inspection should be carried out in accordance with the provisions of GB/T 2829.

6.4.3 The periodic inspection adopts a one-time sampling plan, and its unqualified classification, test group, inspection item, discrimination level, and unqualified quality level (RQL) and sampling plan according to Table 4 (calculated based on the number of non-conforming products per hundred units).