YY/T 0321.2-2021Single-use needle for anaesthesia (English PDF)

3.1 Classification

Single-use needle for anaesthesia (hereinafter referred to as needle for anaesthesia) can be divided into the following categories:

a) epidural puncture needle;

b) lumbar puncture needle;

c) combined anesthesia trocar;

d) nerve block puncture needle.

3.2 Labeling

3.2.1 Product model

The product model labeling is composed of product designation and classification code. Product designation: Represent needle for anaesthesia by AN.

Classification code: Represent epidural puncture needle by E; represent lumbar puncture needle by S; represent combined anesthesia trocar needle by E/S II; represent nerve block puncture needle by N.

Note: For the lumbar puncture needles with Type II cutting edge, the cutting-edge type code should be added after the classification code. Example 1: Single-use needle for anaesthesia - epidural puncture needle:

AN-E Example 2: Single-use needle for anaesthesia - combined anesthesia trocar of epidural puncture needle and type II cutting edge lumbar puncture needle: AN-E/S II

3.2.2 Product specifications

The product specification labeling is represented by the nominal outer diameter of the needle tube × the length of the needle tube. Dimensions in millimeters.

5.3.3 Resistance to corrosion

When testing according to GB/T 18457, there shall be no traces of corrosion on the soaked part of the needle tube.

5.3.4 Outer surface

Observed with normal vision or corrected vision, the outer surface of the needle tube shall be smooth and free of impurities during metal processing.

5.3.5 Graduation line

If the needle tube of the needle for anesthesia has a scale mark, the graduation line shall be clear without broken lines, and the size of the graduation line shall meet the requirements in Figure 1. Immerse the needle tube in water at 18 °C ~ 28 °C for 24 hours; then take it out; wipe the graduation line with white medical gauze. There shall be no color falling off.

5.4 Lining core

5.4.1 The lining core shall have a smooth surface, and shall pass through the inner cavity of the needle for anesthesia; there shall be no blockage in the hand feeling test.

5.4.2 The corrosion resistance of the lining core made of stainless steel shall meet the requirements of 5.3.3.

5.5 Needle tip

5.5.1 When inspecting with a 3x magnifying glass, the needle tip shall be free of burrs, flat ends and hooks.

5.5.2 There shall be no sharp edges on the inner arc of the bevel of the needle tip of the epidural puncture needle. Use an anesthesia catheter of the corresponding specification to insert it from the tapered hole of the needle file until it passes through the bevel of the needle tip by 10 mm, so that the needle tip touches a vertical plane, and the inner arc of the needle forms an included angle of 90° ~ 95° with the catheter. Slowly withdraw the catheter without breaking it. Nominal outside diameter of the needle tube (Specifications)

Distance between rigid support and point of application of bending force The clamp for fixing the needle tube must not damage the needle tube.

6.1 Preparation method of test solution

See Appendix C for the preparation method of test solution.

6.2 Metal ions

When testing according to 5.6.1 in GB/T 14233.1-2008, the color of the test solution shall not exceed the standard control solution with a mass concentration rho(Pb2+) = 5 µg/mL.

When using the atomic absorption spectrophotometry (AAS) in GB/T 14233.1 or an equivalent method for testing, the total content of barium, chromium, copper, lead and tin in the test solution shall not exceed 1 µg/mL, and the content of cadmium shall not exceed 0.1 µg/mL.

6.3 Limits for acidity and alkalinity

When testing according to 5.4.1 in GB/T 14233.1-2008, the difference of pH between the test solution and the same batch of blank solution shall not exceed 1.0.

6.4 Residue of ethylene oxide

If it is sterilized by ethylene oxide, when testing according to Chapter 9 of GB/T 14233.1-2008, the residual amount of ethylene oxide in each anesthesia needle shall not exceed 0.1 mg.

7.1 General

Where there is a production of new products and change in raw materials, the biological evaluation of cytotoxicity, intradermal irritation, skin sensitization, systemic acute toxicity and blood compatibility shall be carried out according to the provisions of GB/T 16886.1.

7.2 Sterility

Each single packaged needle for anesthesia shall pass a sterility validation and routine control to render the product sterile.

Note: See GB 18278.1, GB 18279.1 and GB 18280.1 for appropriate sterilization confirmation and routine control.

7.3 Bacterial endotoxins

When testing according to the gel method in GB/T 14233.2, the bacterial endotoxin limit of single-use needle for anaesthesia shall not exceed 2.15 EU per piece for lumbar puncture needle, and shall not exceed 20 EU per piece for epidural puncture needle and nerve block puncture needle.

8.1 Single package

The single package shall at least include the following information:

a) manufacturer and/or distributor name and address;

b) product name, model, specifications;

c) batch number or production date, or graphic symbols conforming to YY/T 0466.1;

d) expiration date (year and month), with appropriate text attached, or graphic symbols conforming to YY/T 0466.1;

e) words "single-use", or equivalent instructions, or graphic symbols conforming to

YY/T 0466.1;

f) words "sterile" and "sterilization method", or graphic symbols conforming to

YY/T 0466.1;

g) words such as "damaged package, prohibited use" and "destroy after use", or graphic symbols conforming to YY/T 0466.1.

8.2 Shelf or multi-unit packaging

Shelf packs or multi-unit packs (if used) shall be marked with at least the following information:

a) manufacturer and/or distributor name and address;

b) product name, model, specifications;

c) batch number or production date, or graphic symbols given in YY/T 0466.1;

d) expiration date (year and month), with appropriate text attached, or graphic symbols given in YY/T 0466.1;

e) words "single-use", or equivalent instructions, or graphic symbols in accordance with YY/T 0466.1;

A.1 Principle

Pass water under a certain pressure through the inner cavity of the tested piece, and calculate the amount of water flowing out of the tested piece per unit time.

A.2 Test equipment

A.2.1 Flow tester: The water pressure can be adjusted within 0 kPa ~ 300 kPa, the pressure tolerance is ±5%, and the water outlet has an outer conical joint.

A.2.2 A 25 mL graduated cylinder with a minimum scale of 0.5 mL.

A.3 Test steps

A.3.1 Turn on the power of the instrument.

A.3.2 Install the tested piece on the outer conical joint of the water outlet of the instrument. A.3.3 Adjust the water pressure to the standard value. A.3.4 Select the test time.

A.3.5 Start the test switch, let water pour into the measuring cylinder from the outlet of the tested piece, and it will automatically shut down when the stipulated time is reached. A.3.6 Read the water volume in the graduated cylinder.

B.1 Principle

Evaluate particle contamination by flushing the test piece, collecting particles in the eluent of the test piece, and counting them.

B.2 Test equipment

The particle counter (resistance method or light resistance method) has a stirring system, and the sampling volume at a time is not less than 1 mL.

B.3 Flushing solution

Water for injection, purified water or sodium chloride solution with a mass concentration of 9 g/L. Filter through a microporous membrane with a pore size of 0.2 µm.

B.4 Test steps

Use a clean syringe to take 60 mL of flushing solution, and flow it into the sample pool of a clean counter through the measured piece to obtain the eluent. Count the particles larger than or equal to 5.0 µm in the eluate in the sample pool, and the total sampling volume shall not be less than 15 mL.