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YY/T 0321.1-2022 English PDF (YYT0321.1-2022)

YY/T 0321.1-2022 English PDF (YYT0321.1-2022)

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YY/T 0321.1-2022: Single-use puncture set local anaesthesia

This Part of YY/T 0321 specifies the requirements for the classification and labeling, configured instruments, physical properties, chemical properties, biological properties, marking, packaging, transportation and storage of single-use set local anaesthesia. This Part applies to single-use puncture set local anaesthesia for 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.
YY/T 0321.1-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0321.1-2009
Single-use puncture set local anaesthesia
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Classification and labeling ... 6
4 Configurated instruments ... 8
5 Physical properties ... 8
6 Chemical properties ... 10
7 Biological properties ... 11
8 Marking ... 11
9 Packaging ... 12
10 Transportation and storage ... 13
Appendix A (Informative) Reference table for selecting anesthesia set configuration parts ... 14
Appendix B (Normative) Flow test method ... 15
Appendix C (Normative) Catheter breaking force test method ... 16
Appendix D (Normative) Particle content test method ... 17
Appendix E (Normative) Test method for bending resistance of catheters ... 18 Appendix F (Normative) Preparation method of test solution for chemical properties ... 20
References ... 21
Single-use puncture set local anaesthesia
1 Scope
This Part of YY/T 0321 specifies the requirements for the classification and labeling, configured instruments, physical properties, chemical properties, biological properties, marking, packaging, transportation and storage of single-use set local anaesthesia. This Part applies to single-use puncture set local anaesthesia for 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 1962.2, 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 0321.2, Single-use needle for anaesthesia
YY/T 0321.3, Single-use filter for anaesthesia
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 puncture set local anaesthesia (hereinafter referred to as anesthesia set) can be divided into the following categories:
a) epidural anesthesia set;
b) lumbar anesthesia set;
c) combined epidural and lumbar anesthesia set;
d) nerve block set.
3.2 Labeling
3.2.1 Product model
The product model is composed of product designation and classification code. Product designation: Represent anesthesia set by AS.
Classification code: Represent epidural anesthesia by E; represent lumbar anesthesia by S; represent combined epidural and lumbar anesthesia by E/S II; represent nerve block by N.
Note: For the anesthesia set equipped with a type II cutting edge lumbar puncture needle, add the cutting edge type code ?€?II?€? after the classification code. Example 1: single-use puncture set local anaesthesia for epidural anesthesia AS-E
Example 2: single-use puncture set local anaesthesia for combined anesthesia equipped with epidural puncture needle and type II cutting edge lumbar puncture needle AS-E/S II
3.2.2 The labeling of the single-use needle for anaesthesia provided in the anesthesia set shall comply with the requirements in YY/T 0321.2.
3.3 Product configuration
After the catheter is connected to the catheter fitting, close the side hole at the front end of the catheter, and apply a water pressure of 300 kPa to the conical hole of the fitting for 30 s, and there shall be no water dripping from the connection.
5.3.11 Bending resistance
If it is indicated on the label of the single package that the catheter has bending resistance, when testing according to Appendix E, the flow reduction rate after 180?? bending shall not exceed 10%.
5.3.12 Corrosion resistance of steel wire
If the catheter has a built-in steel wire, when testing according to GB/T 18457, there shall be no traces of corrosion on the steel wire.
6 Chemical properties
6.1 Preparation method of test solution
See Appendix F for the preparation method of test solution.
6.2 Reducing substance (readily oxidizable substance)
When testing according to 5.2.2 in GB/T 14233.1-2008, the difference in the volume of the potassium permanganate solution [c (KMnO4 = 0.002 mol/L] consumed by the test solution and the blank solution shall not exceed 2.0 mL.
6.3 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 ??(Pb2+) = 5 ??g/mL.
When using the atomic absorption spectrophotometry (AAS) in GB/T 14233.1-2008 or an equivalent method for testing, the total content of barium, chromium, copper, lead and tin in the test solution shall not exceed 1 ??g/mL, and the content of cadmium shall not exceed 0.1 ??g/mL.
6.4 Limits for acidity and alkalinity
When testing according to 5.4.1 in GB/T 14233.1-2008, the difference of pH value between the test solution and the same batch of blank solution shall not exceed 1.0. 6.5 Evaporation residue
When testing according to 5.5 in GB/T 14233.1-2008, the total content of evaporation residue shall not exceed 5 mg.
6.6 Ultraviolet absorbance
When testing according to 5.7 of GB/T 14233.1-2008, within the wavelength range of 250 nm ~ 320 nm, the absorbance of the test solution shall not be greater than 0.1. 6.7 Residue of ethylene oxide
If the anesthesia set is sterilized by ethylene oxide, when testing according to Chapter 9 of GB/T 14233.1-2008, the total residual amount in single-use needles for anaesthesia, catheters and catheter fittings, and fluid filters in each single package shall not be greater than 0.5 mg, and the residual amount of excipients in the package shall be ???250 ??g/g.
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 anesthesia set shall pass a sterilization validation process and routine controls to render the product sterile.
Note: See GB 18278.1-2015, GB 18279.1-2015 and GB 18280.1-2015 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 each device in contact with the liquid medicine shall not exceed 20 EU, and the bacterial endotoxin limit of lumbar puncture needles shall not exceed 2.15 EU per device.
8 Marking
8.1 Single package
The single package shall be marked with at least the following information: a) manufacturer and/or distributor name and address;
b) product name, model and specifications of the configured single-use needle for anaesthesia;
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 ?€?one-time use?€?, or equivalent instructions, or graphic symbols given in YY/T 0466.1;
f) words ?€?sterile?€? and ?€?sterilization method?€?, or graphic symbols given in YY/T 0466.1;
g) words such as ?€?damaged package, prohibited use?€? and ?€?destroy after use?€?, or graphic symbols in accordance with 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 and specifications of the configured single-use needle for anaesthesia;
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 ?€?one-time use?€?, or equivalent instructions, or graphic symbols given in YY/T 0466.1;
f) words ?€?sterile?€? and ?€?sterilization method?€?, or graphic symbols given in YY/T 0466.1;
g) the number of anesthesia sets;
h) recommended storage conditions (if any).
9 Packaging
9.1 The packaging of the anesthesia set shall comply with the regulations of YY/T 0313. If ethylene oxide is used for sterilization, the material of the single package of anesthesia set shall be the material with dialysis function.
9.2 Rubber medical gloves, medical gauze, drapes and other auxiliary materials in the single package shall be placed separately from the instruments and accessories in the single package that are in contact with liquid medicine and blood.
Appendix B
(Normative)
Flow test method
B.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. B.2 Test equipment
B.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. B.2.2 A 25 mL graduated cylinder with a minimum scale of 0.5 mL.
B.3 Test steps
B.3.1 Turn on the power of the instrument.
B.3.2 Install the tested piece on the outer conical joint of the water outlet of the instrument.
B.3.3 Adjust the water pressure to the standard value.
B.3.4 Select the test time.
B.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 set time is reached. B.3.6 Read the water volume in the graduated cylinder.
Appendix D
(Normative)
Particle content test method
D.1 Principle
This method evaluates particle contamination by flushing the test piece, collecting particles in the eluent of the test piece, and counting them.
D.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.
D.3 Flushing solution
Water for injection or purified water or sodium chloride solution with a mass concentration of 9 g/L, filtered through a microporous membrane with a pore size of 0.2 ??m.
D.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 ???5.0 ??m in the eluate in the sample pool, and the total sampling volume shall not be less than 15 mL.
Appendix E
(Normative)
Test method for bending resistance of catheters
E.1 Principle
Pass water under a certain pressure through the inner cavity of the measured catheter, and calculate the amount of water flowing out of the catheter per unit time; then, bend the measured catheter in half and put it into a groove twice the diameter of the width, and repeat the test again to calculate the outflow of liquid quantity.
E.2 Test equipment
E.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. E.2.2 A 25 mL graduated cylinder with a minimum scale of 0.5 mL.
E.3 Test steps
E.3.1 Turn on the power of the instrument.
E.3.2 Install the tested catheter on the outer conical joint of the water outlet of the instrument.
E.3.3 Adjust the water pressure to the standard value.
E.3.4 Select the test time.
E.3.5 Start the test switch, let water pour into the measuring cylinder from the outlet of the tested catheter, and it will automatically shut down when the set time is reached. E.3.6 Read the water volume V1 in the graduated cylinder.
E.3.7 Bend the measured catheter according to the method shown in Figure E.1; put it into a groove of a width twice the diameter to repeat the test once; record the flow rate as V2.

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