YY/T 0105-2020Intradermal needles (English PDF)

3.1 Subcutaneously embedded small acupuncture tool

Note. There are two types of intradermal needles. one is a granular intradermal needle, and the other is a snap-type intradermal needle (punch needle).

4.1 Structure

The typical structure of the intradermal needle and the names of its components are shown in Figure 1, Figure 2, and Figure 3.

4.2 Classification

According to whether it is sterile or not, intradermal needles can be divided into two types. sterile and non-sterile.

According to the method of use, snap-type intradermal needles (punch needles) can be divided into non-electric acupuncture needles and electro-acupuncture needles.

According to the combination of the needle tip and the needle handle, intradermal needles can be divided into two types. one-piece type and non-one-piece type.

4.3 Specifications and materials

The specifications of intradermal needles are expressed as needle diameter×needle length. Example. Phi0.25×2mm.

See Appendix A for the materials used to make intradermal needles.

5.1 Dimensions

5.1.1 The basic dimensions and tolerances of typical granular intradermal needles should meet the requirements of Table 1. a If the size of the intradermal needle is not within the scope of Table 1, the manufacturer shall specify the relevant size and tolerance.

5.1.2 The basic dimensions and tolerances of a typical snap-type intradermal needle (snap needle) should meet the requirements of Table 2.

5.2 Needle tip strength and sharpness

After the needle tip is applied with the force specified in Table 3 to contact the steel block, its piercing force should not be greater than that specified in Table 3.

5.3 Needle body hardness

The hardness of the needle body should meet the requirements of Table 4.

5.4 Surface roughness

The maximum value of the surface roughness parameter R A of the needle body and the needle tip should be 0.4 µm.

5.5 Corrosion resistance Intradermal needles should have good

corrosion resistance.

5.6 The firmness of the needle body and the needle handle

The connection between the needle body and the needle handle of the non-integrated intradermal needle should be firm. When the static tension specified in Table 5 is applied to the center axis of the needle When facing the time, the needle body and the needle handle are not separated.

5.7 Sterile

Sterile intradermal needles should be sterilized through a confirmed sterilization process to ensure the sterility of the product.

Note. For suitable sterilization methods, please refer to the confirmation and routine control of the sterilization process of medical devices specified in the documents GB 18278.1, GB 18279 and GB 18280. System requirements.

5.8 Biocompatibility

The part expected to be in contact with the patient's skin should be evaluated and shaped according to the guidelines and principles given in Appendix A of GB 168886.1-2011 Into a file.

5.9 Appearance

5.9.1 The needle tip should be sharp, round and right, free of burrs, hooks and other defects.

5.9.2 There should be no scars, bends and pits on the surface of the needle.

5.9.3 For the needle handles of the integrally formed intradermal needles, the spiral loops should be round and straight, arranged closely, and there should be no obvious separation. Non-integrated intradermal needle The plane of the needle body and the connected needle handle should be perpendicular. The circular plane of the needle body of the snap-type intradermal needle (punch needle) and the connected needle handle should be perpendicular. Granule The needle body of the type intradermal needle should be parallel to the plane of the connected needle handle, and there should be no obvious deviation.

6.1 General

Except for sterility and biocompatibility tests, no less than 3 samples are taken for other items for testing.

6.2 Dimensions

The use of general measuring tools or special measuring tools should meet the requirements of 5.1.

6.3 Point strength and sharpness

According to the method of 5.3.2 in GB 2024-2016, it should meet the requirements of 5.2.

Note. A typical granular intradermal needle with the needle body and the needle handle at the same cross-section. If the needle body length is less than 5mm, the raw material needle blank can be used (the exposed part of the clamp is not larger than the standard Weigh the length of the needle body for the test; the needle body and the needle handle are not at the same cross-section of the intradermal needle (punch needle), if the needle body length is less than 7mm, the raw material needle blank (holding The exposed part shall not be greater than the nominal length of the needle body) for the test.

6.4 Needle body hardness

The test is carried out according to the method of GB/T 4340.1 and should meet the requirements of 5.3.

Note. Needle body length < 25mm can use raw material needle blanks for testing.

6.5 Surface roughness

Use a 10x magnifying glass to compare with the standard surface roughness sample block, and it should meet the requirements of 5.4.

6.6 Corrosion resistance

Carry out according to the method of citric acid solution test method in Chapter 7 of YY/T 0149-2006, check the corrosion marks on the surface of the test piece, and its corrosion The degree should be free of any corrosion (level a) and meet the requirements of 5.5.

6.7 The firmness of needle body and needle handle

When the length of the needle body L2>=2.5mm, the test shall be carried out in accordance with the method in Appendix B or an equivalent method, and the result shall meet the requirements of 5.6.needle When the body length L2< 2.5mm, insert the entire length of the needle body of the intradermal needle into the simulated skin model, and then pull it out. After repeating 10 times, check the needle The connection between the body and the needle handle should be firm. The recommended simulated skin model should meet the following requirements.

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