YY/T 0821-2022 PDF in English
YY/T 0821-2022 (YY/T0821-2022, YYT 0821-2022, YYT0821-2022)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YY/T 0821-2022 | English | 320 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Dispensing syringe for single use
| Valid |
| YY/T 0821-2010 | English | 719 |
Add to Cart
|
3 days
|
Dispensing syringe for single use
| Obsolete |
Standards related to (historical): YY/T 0821-2022
PDF Preview
YY/T 0821-2022: PDF in English (YYT 0821-2022) YY/T 0821-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY/T 0821-2010
Dispensing syringe for single use
ISSUED ON: JULY 01, 2022
IMPLEMENTED ON: JULY 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Structure ... 8
5 Naming and labeling ... 8
6 Physical requirements ... 10
7 Chemical requirements ... 18
8 Biological requirements ... 18
9 Packaging ... 18
10 Marking ... 18
11 Storage ... 18
Appendix A (Normative) Particle contamination test method ... 19
Appendix B (Normative) Puncture debris test method ... 20
References ... 22
Dispensing syringe for single use
1 Scope
This Standard specifies the requirements for dispensing syringe for single use
(hereinafter referred to as “dispensers”).
This Standard applies to the dispensers used for clinical extraction or preparation of
liquid medicine.
This Standard does not apply to manual syringes for injection immediately after
pumping liquid, insulin syringes, glass syringes, permanent needled syringes, syringes
with power-driven syringe pumps, self-destructing syringes of a fixed dose of vaccines,
syringes to prevent reuse, syringes that are pre-filled with liquid medicine in the
manufacturer and syringes matched with liquid medicine, etc. This Standard does not
involve filters for injection of liquid medicine.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies to this document. For
undated references, the latest edition (including any amendment) applies to this
document.
GB/T 6682, Water for analytical laboratory use - Specification and test methods
GB 8368, Infusion sets for single use - Gravity feed
GB 15810-2019, Sterile syringes for single use
GB 15811, Sterile hypodermic needles for single use
GB/T 18457-2015, Stainless steel needle tubing for the manufacture of medical
devices
GB 18671-2009, Intravenous needles for single use
YY/T 0296, Hypodermic needles for single use ― Colour coding for identification
YY/T 0908-2013, Single-use filter for syringe
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications
- Part 7: Connectors for intravascular or hypodermic applications
3 Terms and definitions
The following terms and definitions are applicable to this document.
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.
6.3.1.3 The graduated capacity line shall be uniform in thickness and shall be located
on a plane at right angles to the axis of the barrel.
6.3.1.4 The graduated capacity lines shall be evenly spaced along the longitudinal axis
of the barrel between the zero line and the total graduated capacity line.
6.3.1.5 When the dispenser is maintained in a vertical position, the ends of all graduated
capacity lines of equal length shall be vertically aligned with each other.
6.3.1.6 The length of the secondary graduated capacity line is about 1/2 of the length of
the main graduated capacity line.
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
6.4.1 Size
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 Chemical requirements
7.1 Body: GB 15810-2019 applies.
7.2 Dispensing needle: GB 15811 applies.
8 Biological requirements
8.1 Body: GB 15810-2019 applies.
8.2 Dispensing needle: GB 15811 applies.
9 Packaging
GB 15810-2019 applies.
10 Marking
10.1 GB 15810-2019 applies.
10.2 There shall be a warning language of “do not inject into the human body” on the
primary packaging, secondary packaging and large packaging.
10.3 If the dispensing needle is equipped with a medicine liquid filter membrane, the
primary packaging, secondary packaging and large packaging shall have the medicine
liquid filter medium specification (nominal pore size) or the mark specified in 5.3.
11 Storage
GB 15810-2019 applies.
Appendix B
(Normative)
Puncture debris test method
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.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
|