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YY/T 0321.2-2021 (YY/T0321.2-2021)

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YY/T 0321.2-2021: PDF in English (YYT 0321.2-2021)

YY/T 0321.2-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0321.2-2009
Single-use needle for anaesthesia
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: APRIL 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Classification and labeling ... 6
4 Materials ... 9
5 Physical properties ... 9
6 Chemical properties ... 15
7 Biological properties ... 15
8 Marking ... 16
9 Packaging ... 17
10 Transportation and storage ... 17
Appendix A (Normative) Flow test method ... 18
Appendix B (Normative) Particle content test method ... 19
Appendix C (Normative) Preparation method of test solution for chemical properties
... 20
References ... 21
Foreword
YY 0321 consists of the following parts:
-- Single-use puncture set local anaesthesia;
-- Single-use needle for anaesthesia;
-- Single-use filter for anaesthesia.
This Part is Part 2 of YY 0321.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0321.2-2009 Single-use needle for anaesthesia.
Compared with YY 0321.2-2009, the main technical changes, except editorial changes,
are as follows:
-- Add a schematic diagram of matching type of cutting edge and lumbar puncture
needle (see Figure 1; Figure 1 of the 2009 edition);
-- Modify the needle tube length of “basic dimensions of needle for anaesthesia” (see
5.1; 3.4 of the 2009 edition);
-- Modify the requirements for the “scale line” of the needle tube (see 5.3.5; 5.2.5 of
the 2009 edition);
-- Modify the requirements for “the inner arc of the bevel of the needle tip of the
epidural puncture needle” (see 5.5.2; 5.4.2 of the 2009 edition);
-- Modify the requirements and test methods for “connection firmness” (see 5.7; 5.6
of the 2009 edition);
-- Add the requirements for “the total content of barium, chromium, copper, lead and
tin in the test solution” in metal ions (see 6.2);
-- Delete “Note 2” on the applicability of the sterility test method in sterility (see 7.1
of the 2009 edition);
-- Modify the requirements for “marking” and delete the requirements for
“instructions for use” (see Chapter 8; Chapter 8 of the 2009 edition);
-- Modify the requirements for “packaging” (see Chapter 9; Chapter 9 of the 2009
edition);
-- Delete the inspection rules of type inspection (see Appendix D of the 2009 edition).
Please note that some of the contents of this document may involve patents. The issuing
organization of this document is not responsible for identifying these patents.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee 95 on Injector
for Medical Purpose of Standardization Administration of China (SAC/TC 95).
Drafting organization of this Part: Zhejiang FERT Medical Device Co., Ltd., Shanghai
SA Medical Technology Co., Ltd., Shanghai Medical Device Testing Institute, Jiangxi
HONGDA Medical Equipment Group Ltd., Henan Tuoren Medical Device Co., Ltd.,
Kangdelai Zhejiang Medical Devices Co., Ltd., B.braun Medical (Shanghai)
International Trading Co., Ltd.
Chief drafting staffs of this Part: Su Weidong, Sun Hongrong, Hua Songhe, Xiong
Rongrong, Liu Yanhong, Zhang Qian, Zhang Yan.
The previous versions of the standard – which are replaced by this Part – are:
-- YY 0321.2-2000, YY 0321.2-2009.
Single-use needle for anaesthesia
1 Scope
This Part of YY 0321 specifies the classification and labeling, materials, physical
properties, chemical properties, biological properties, marking, packaging,
transportation and storage of single-use needle for anaesthesia with a nominal outer
diameter of 0.4 mm ~ 2.1 mm.
This Part applies to single-use needle for anaesthesia for puncture and drug injection
during human epidural nerve block (referred to as epidural anesthesia), subarachnoid
space block (referred to as lumbar anesthesia), combined epidural and lumbar
anesthesia, and local anesthesia of nerve block.
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 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings
GB/T 6682, Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for
medical use - Part 1: Chemical analysis methods
GB/T 14233.2, Test methods for infusion, transfusion, injection equipment for
medical use - Part 2: Biological test methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
GB/T 18457, Stainless steel needle tubing for the manufacture of medical devices
YY/T 0313, Medical polymer products - Requirement for package and information
supplied by manufacturer
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements
3 Classification and labeling
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.
Table 3 (continued)
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
mm
The clamp for fixing the needle tube must not damage the needle tube.
6 Chemical properties
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 ρ(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 Biological properties
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 Marking
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;
Appendix A
(Normative)
Flow test method
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.
Appendix B
(Normative)
Particle content test method
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.
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.