YY/T 0821-2022Dispensing syringe for single use (English PDF)

3.1 Nominal capacity

The capacity of dispenser indicated by the manufacturer.

Note: such as 20 mL, 30 mL, 50 mL.

3.2 Graduated capacity

The volume of water - at a temperature of 18 °C ~ 28 °C - discharged from the body, when the fiducial line of the piston moves axially for a given scale interval.

3.3 Total graduated capacity

The capacity of the body from the zero mark to the furthest mark.

Note: The total graduated capacity can be greater than or equal to the nominal capacity.

3.4 Maximum usable capacity

The capacity of the body when the plunger stopper is drawn to its farthest functional position.

3.5 Fiducial line

The ring line at the end of the plunger stopper, which is in contact with and vertical to the barrel of the body, and is aligned with the zero-graduation line on the barrel of the body when the piston is fully pushed to the bottom of the casing.

3.6 Dispensing needle

The combination of needle tube, needle file and sheath, which can be divided into two types - side-hole and bevel - according to the needle tip type.

3.7 Side-hole needle

A needle tube with a closed tip and an opening on one or both sides adjacent to the tip.

3.8 Bevel needle

A needle tube with a bevel opening on one end and an included angle with its axis.

3.9 Plunger stopper

Sealing assembly between the barrel and the plunger (3.10).

c) Express the division capacity line of the additional scale by a shorter scale line;

d) Express vertical lines of the additional scale lengths by dotted lines.

6.3.2 Numbers on the scale

The graduated line shall be marked according to the maximum incremental value specified in Table 1. If the nominal capacity line is inconsistent with the total graduated capacity line, it shall be marked with numbers. Hold the dispenser vertically, with the cone pointing up; the number shall be vertically located on the ruler, and shall be in the center half of the extension line of the corresponding capacity scale. The numbers shall be close to, but not touching the ends of the corresponding graduated line.

6.3.3 Total length of the scale of the nominal capacity line

The total length of the scale shall meet the requirements in Table 1.

6.3.4 Scale position

When the plunger stopper is fully pushed to the bottom of the barrel, the zero-graduation line of the scale shall be aligned with the fiducial line on the plunger stopper, and the error shall meet the capacity tolerance requirements in Table 1.

6.3.5 Printing of scales

6.3.5.1 The scale of the partial-head dispenser shall be printed on the opposite side of the cone.

6.3.5.2 The scale of the center-head dispenser shall be printed on either side of the short axis of the barrel flanges.

6.3.5.3 The graduated capacity line and digital printing shall be complete, with clear handwriting, distinct lines and uniform thickness.

6.4 Barrel

6.8.1.5 Particle contamination

Test in accordance with Appendix A; the contamination index of the dispensing needle of the side-hole needle shall not exceed 90.

6.8.1.6 Filtration rate (if with medicine liquid filter membrane)

When testing according to A.1 in the appendix of YY/T 0908-2013, the filtration rate shall not be less than 90%.

6.8.1.7 Puncture debris

When testing in accordance with Appendix B, no more than 3 debris shall be produced for every 100 punctures.

6.8.2 Needle file

6.8.2.1 The conical joint of the needle file shall meet the requirements of ISO 80369-7.

6.8.2.2 Observed with normal or corrected vision, the needle file shall have no obvious rough selvedge, burrs, plastic flow and bubble injection defects.

6.8.2.3 The needle file and the sheath shall fit well, and the sheath shall not fall off naturally and be easy to remove.

6.8.3 Color scale

The color of the needle file and /or sheath shall be used as the mark of the nominal outer diameter of the needle tube for the dispensing needle, which shall meet the requirements of YY/T 0296.

6.8.4 Connection firmness

The needle tube and the needle file shall be firmly connected. Fix the needle file on the special instrument, and do a non-impact pull-out test under the load specified in Table 6 in the direction in which the needle file is pulled out, and the two shall not be loosened or separated.

7.1 Body: GB 15810-2019 applies

7.2 Dispensing needle: GB 15811 applies

8.1 Body: GB 15810-2019 applies

8.2 Dispensing needle: GB 15811 applies

10.1 GB 15810-2019 applies

B.1 Principle

Use the dispensing needle to puncture the cork system of the injection bottle, and collect the resulting debris and count.

B.2 Instruments

B.2.1 Washing solution: freshly made, in accordance with the requirements for grade-2 water or purified water in GB/T 6682, and filtered through a filter membrane with a pore size of 0.8 µm.

B.2.2 Injection bottle: Fill the washing solution (B.2.1) to half of the injection bottle, and seal it with a sealing system.

B.2.3 Patcher: A device for flushing out the particles in the channel, such as a single-use sterile syringe.

B.3 Test samples and injection stoppers

See Table B.1 for test samples and injection stoppers. Table B.1 - Test samples and injection stoppers

Test sample Injection stopper Type Requirements 25 tubes of dispensing needle Injection stopper

ISO 8362-2-20-A Hardness: Shore (A) 40 ~ Shore (A) 55

Note: ISO 8362-2-20-A represents the butyl rubber stopper of type 20-A in ISO 8362-2.

B.4 Pretreatment

B.4.1 No pretreatment is required for the dispensing needles. Injection stoppers need to be sterilized and dried. The injection stopper shall be sterilized in an autoclave and kept at (121±2) °C for 30 minutes.

B.4.2 Put the autoclaved injection stopper into the oven, and dry it at 60 °C for 60 minutes.

B.4.3 The injection bottle (B.2.2) shall be cleaned so that it does not contain particulate matter, so as to avoid false test results. […]