YY 1001-2024 PDF English
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Glass syringes
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Glass syringes - Part 1: Syringes with all-glass
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YY 1001-2024: Glass syringes---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY1001-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
CCS C 31
Replacing YY 1001.1-2004, YY1001.2-2004
Glass syringes
Issued on. FEBRUARY 07, 2024
Implemented on. MARCH 01, 2026
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Structural form... 6
5 Materials... 7
6 Requirements and test methods... 7
7 Marking... 11
8 Packaging... 12
9 Transportation and storage... 12
Annex A (normative) Test methods for capacity tolerance, durability of graduation lines
and metering numbers... 13
Annex B (informative) Syringe cleanliness... 14
Bibliography... 15
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
“Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents”.
This document replaces YY 1001.1-2004 “Glass syringes - Part 1.Syringes with all-
glass” and YY 1001.2-2004 “Glass syringes - Part 2.Blue syringes with all-glass”.
Compared with YY 1001.1-2004 and YY 1001.2-2004, in addition to structural
adjustments and editorial changes, the main technical changes are as follows.
- ADD barrel flange (see Figure 1, 6.17 of this document);
- DELETE “Matching code” (see 5.12 of the 2004 edition);
- DELETE “Inspection rules” (see Clause 7 of the 2004 edition);
- DELETE “Instructions for use” (see 8.2 of the 2004 edition).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee on Medical
Syringes (Needles) of Standardization Administration of China (SAC/TC 95).
The previous released versions replaced by this document are as follows.
- YY 1001.1, first published in 1999 as YY 91001-1999, first revised in 2004 as YY
1001.1-2004;
- YY 1001.2, first published in 1999 as YY 91061-1999, first revised in 2004 as YY
1001.2-2004.
Introduction
There is currently no relevant standard for glass syringes used for negative pressure
detection in epidural anesthesia surgery. Their structure and materials are basically the
same as those of the glass syringes in this document. Therefore, this document
encourages manufacturers to refer to the relevant provisions of Clause 6 for the
performance indicators of glass syringes for negative pressure detection.
Glass syringes
1 Scope
This document specifies the structural type, materials, requirements, marking,
packaging, transportation and storage of glass syringes and blue syringes with all-glass
(hereinafter referred to as “syringes”), and describes the corresponding test methods.
This document applies to glass syringes and blue syringes with all-glass. After the
product is equipped with an injection needle, it is used for subcutaneous, intramuscular,
and intravenous injection of liquid and extraction of liquid.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 1962.1 Conical fittings with a 6 % (Luer) taper for syringes, needles and
certain other medical equipment - Part 1.General requirement
YY 91017 Test method of leakage between barrel and plunger of medical glass
syringes
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
glass syringes
Medical syringes of which the barrel, plunger and hub are all made of borosilicate
aluminum glass material and can be reused after sterilization.
3.2
blue syringes with all-glass
Syringes of which the barrel, plunger and hub are all made of borosilicate aluminum
glass material (the plunger is blue solid) and can be reused after sterilization.
3.3
nominal capacity
Syringe capacity marked by the manufacturer.
4 Structural form
The structural form of syringes is shown in Figure 1.
5 Materials
The syringes shall be made of borosilicate aluminum glass.
6 Requirements and test methods
6.1 Dimensions
Measured with general or special measuring tools, the maximum length (L) and hub
aperture (H) of the syringes shall comply with the provisions of Table 1.
6.3 Conical fitting
The conical fitting dimensions of the syringes shall meet the requirements of GB/T
1962.1.
6.4 Capacity tolerance
Test in accordance with A.1 in Annex A, the capacity tolerance of the syringes shall
meet the requirements of Table 3.
6.5 Position of graduation lines and metering numbers
After testing in accordance with A.2, the graduation lines and metering numbers of the
syringes shall be complete, uniform in thickness, and durable, the lines shall be straight
and equally divided, and the graduation lines shall be perpendicular to the axis of the
6.6 Metering numbers
After testing in accordance with A.2, the position of metering numbers of the syringes
is shown in Figure 1.The writing direction is parallel to the axis of the syringe body.
The arrangement of metering numbers starts from the zero line, and the word “0” can
be omitted. The metering numbers of syringes of various specifications shall meet the
requirements of Table 4.
6.10 Hub tightness
The syringe hub shall fit tightly with the injection needle. Suck 1/4 of the capacity of
water into the syringe, then clean and dry the syringe hub and the standard fitting cone
hole that meets the requirements of GB/T 1962.1 and tighten them, put the syringe flat
on the tightness tester, and pass the specified water pressure value from the barrel fitting.
When subjected to a water pressure of 300 kPa, no water shall drip within 30 s.
6.13 Residual liquid volume in syringe
Suck water into the dry syringe to the nominal capacity, then remove the air, push the
plunger to the bottom of the barrel and pull it out, so that the water on the plunger and
the barrel wall can fully circulate and concentrate at the bottom of the barrel; use a
syringe of appropriate specifications (0.25 mL, 1 mL, 2 mL) with a long injection
needle, completely absorb the water remaining in the barrel (including the hub hole),
and then read the value as the residual liquid volume. The residual liquid volume of the
syringe shall not exceed the requirements of Table 6.
6.15 Welding firmness
The syringe barrel and hub shall be welded firmly and straight, so that the syringe is in
a horizontal position. The force specified in Table 7 is evenly applied to the middle of
the frosted surface of the hub, then the force is removed, and the hub is rotated 180°
along the axis. Repeat the force again, the two shall not separate.
6.17 Cut edge of barrel
The opening at the end face of the barrel shall have a cut edge to ensure that the syringe
shall not rotate 180° when placed on a surface with an angle of 10° to the horizontal,
and there shall be no shaking of itself and no sharp edges.
7 Marking
7.1 Unit packaging
The unit packaging shall have at least the following information.
7.2 Shelf or multi-unit packaging
Shelf packaging or multi-unit packaging (if used) shall be marked with at least the
following information.
8 Packaging
8.1 The packaged syringes shall be clean and dry, and soft padding shall be placed in
the barrel. The packaging box shall have cushion to prevent the syringe from loosening
or hitting to prevent damage to the syringe.
9 Transportation and storage
9.1 The syringes shall be protected from heavy pressure, direct sunlight, rain and snow
during transportation.
9.2 The syringes shall be stored in a clean environment without corrosive gases and
with good ventilation.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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