YY/T 0328-2015 English PDF (YYT0328-2015)

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YY/T 0328-2015: A.V. fistula needle sets for single use
YY/T 0328-2015
AVfistula needle sets for single use
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0328-2002
Disposable arteriovenous trocar
Published on.2015-03-02
2016-01-01 Implementation
The State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This standard replaces YY 0328-2002 "One-time use of blood collection device for machines", compared with YY 0328-2002, the main technical changes
as follows.
--- Modified the standard Chinese and English names;
--- Increased description of the dual type;
--- Abolished the description of the product tag;
--- Modify the requirements of particulate pollution;
--- Modify the sealing requirements;
--- Modify the flow requirements;
--- Modify the needle needle requirements;
--- Modify the appearance of the needle handle requirements;
--- Revised the recommended requirements of needle color scale;
--- Increased the recommendation of the stop-clip color standard;
--- Increased the recommended requirements for protection against needle sticks;
--- Modify the pH requirements and test methods;
--- Modify the total amount of evaporation residue requirements;
--- Increased if not a single package should be marked with the number and recommended maximum positive and negative pressure requirements.
This standard is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
This standard is mainly drafted by. Shandong Provincial Medical Device Product Quality Inspection Center.
Participated in the drafting of this standard. Dalian JMS Medical Appliance Co., Ltd., Tianjin Hana Hao Medical Equipment Co., Ltd., Shandong Weigao Group
Medical Polymer Products Co., Ltd.
The main drafters of this standard. Li Ming, Jia Yufei, Xu Hui, Sun Bingcheng, Zhu Chunbin, Li Yu, Zhao Hengkun.
This standard was first published in January.2002.
introduction
One-time use of arteriovenous puncture device and blood component collection machine (such as centrifugal type, rotating membrane type) or hemodialysis machine, etc.
The body vein or artery collects blood and returns the processed blood or blood components to the human body.
Disposable arteriovenous trocar
1 Scope
This standard stipulates the requirements for the use of disposable arteriovenous puncture devices (hereinafter referred to as puncture devices) to ensure the blood vessels and blood that are provided with them.
The processing system adapts.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) conical joints Part 2. Locking joints
GB 8369 One-time use of blood transfusion device
GB/T 14233.1-2008 Medical infusion, blood transfusion, injection equipment inspection methods Part 1. Chemical analysis methods
GB/T 14233.2 Medical infusion, blood transfusion and injection equipment test methods Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices Part 1. Assessment and testing in risk management process
GB 18457 Stainless Steel Needle for Medical Device Manufacturing
GB 18671-2009 Disposable intravenous infusion needle
YY/T 0466.1 Medical Devices Symbols for Medical Devices Signs, Labels, and Information Providing Part 1. General Requirements
ISO 11607-1.2006 Packaging for terminally sterilized medical devices Part 1. Requirements for materials, sterile barrier systems, and packaging systems 1)
1) The Chinese standard GB/T 19633.1 equivalent to ISO 11607-1.2006 is currently in the approval stage.
3 Structure
The typical trocar structure is shown in Figure 1.
Note. Figure 1 shows the structure of a single puncture device, not the only type specified in this standard. Dual-line trocars are also available on the market.
4 Material requirements
4.1 The material of the piercer given in Chapter 3 of the manufacture shall meet the requirements of Chapter 5. Punctures in contact with blood and blood components
The items should also meet the requirements specified in Chapters 6 and 7.
4.2 The puncture needles should be made of stainless steel needles that comply with the provisions of GB 18457.
Explanation.
1 --- needle protection sleeve;
2 --- puncture needle;
3 --- needle handle;
4 --- needle protection device;
5 --- stop clips;
6--- hose;
7 --- inner cone joint;
8 --- connector protective cover.
Fig.1 Schematic diagram of one-way trocar
5 Physical requirements
5.1 Particle Pollution
Punctures should be made with minimal particulate contamination. The liquid passage surface should be smooth and clean. When tested according to Appendix A, the pollution index
Should not exceed 90.
5.2 Sealing
5.2.1 Fill the trocar with (37 ± 1) °C water. Seal one end of the puncture device and apply 1.5 times the manufacturer's recommended maximum positive pressure at the other end.
A positive pressure of 50 kPa minimum (whichever is greater) is maintained for at least 10 minutes, after which the trocar should be visually inspected for no leakage.
5.2.2 Fill the trocar with (37 ± 1) °C water. Seal one end of the trocar and apply 1.5 times the manufacturer's recommended maximum negative pressure at the other end.
Maximum negative pressure of 93.3kPa (pressure below atmospheric pressure 700mmHg) or if the available low pressure value is not exceeded at high altitude
The smaller ones are kept for at least 10 min, after which the trocar should be visually observed to be leak free.
5.3 Connection strength
The joints of the components of the puncture device (excluding the protective sleeve) shall be able to withstand the static axial tensile force of not less than 15N for 15s.
Cracked and falling off.
5.4 Traffic
When the trocar is tested in a (23 ± 2) °C environment, the flow rate of the simulated blood is recorded within 1 min under the pressure difference specified in Table 1.
Should comply with the provisions of Table 1.
Note. The simulated blood for the test is a glucose solution of 400 g/L.
Table 1 Flow Requirements, Color Marks, and Back Hole Area Requirements
specification
Mm
10kPa pressure flow conditions
mL/min
30kPa pressure flow conditions
mL/min
Recommended color
Back hole area
Mm2
1.2(18G) ≥15 ≥125 Pink ≥0.5
1.4(17G) ≥24 ≥200 Orange ≥0.8
1.6(16G) ≥30 ≥250 Green ≥1.0
1.8(15G) ≥38 ≥320 Beige ≥1.3
2.1(14G) ≥45 ≥380 Purple ≥1.6
5.5 Hose
5.5.1 Hoses should be plasticized evenly, without kinks, and transparent or sufficiently transparent. When bubbles pass through, they can be made with normal or corrected vision.
The interface between water and air.
5.5.2 The inner diameter of the hose should not be less than 2.7mm, wall thickness ≥ 0.65mm, and length 150mm~300mm.
5.6 Puncture needle
5.6.1 Needle
5.6.1.1 The tip of the puncture needle should have a back hole, and the area of the back hole (if there is a back hole) should comply with Table 1. The back hole should be smooth and there should be no hair
Thorn, flanging.
5.6.1.2 Puncture needles Syringes shall be thin-walled or ultra-thin-walled in accordance with the provisions of GB 18457. The effective length of the needle tube should be nominal
±2mm.
Note. If GB 18457 ultrathin wall needle needle rigid requirements, needle needle should be used in accordance with the provisions of GB 18457 ultra-thin wall needle to increase blood
Liquid flow rate.
5.6.2 Tip
The tip of the needle should be sharp. Under normal 2.5x magnification and with normal or corrected vision, the needle tip should be free of burrs, burrs, and hooks.
Note. The first bevel angle of the tip is usually (17±2)°, but “long bevel angle” may also be used, such as (12±2)°. GB 18671-2009 Chapter D.2 give
Needle tip geometry and naming labels. When describing the configuration of the needle tip, it is not necessary to use all of the illustrations shown. GB 18671-2009 Section D.3
The method for evaluating the needle tip puncture performance is given.
5.6.3 Lubricants
If the needle is coated with a lubricant and the normal or corrected vision is observed, there should be no visible accumulation of lubricant on the outside surface of the needle.
Note. The suitable lubricant is undiluted polydimethylsiloxane in accordance with national pharmacopoeia. The amount of lubricant per square centimeter of the surface of the needle should not exceed
0.25mg.
5.6.4 Needle handle
5.6.4.1 Appearance
The appearance should meet the following requirements.
a) The needle blade of the needle handle should be complete without burrs;
b) In the appropriate position of the needle shank, the nominal outer diameter of the needle should be marked, and the marking should be clear.
Note. There should be embossed buckles on the needle blade to facilitate finger gripping to control the angle of the puncture needle.
5.6.4.2 Color standard
The needle shank color should be used to indicate the outer diameter of the puncture needle. The color specified in Table 1 is recommended.
5.6.4.3 Needle handle direction
The needle handle should be in the same direction as the needle bevel (as shown in Figure 1).
NOTE. Active needles that can rotate axially around the needle handle are not subject to this paragraph, but additional indications of the direction of the bevel of the needle tip must be provided on the needle handle.
5.7 flow stop clamp
5.7.1 The flow stop clip on the puncture device should be a locking pin. Stop clamps should be able to open and close the hose effectively, and should be blocked above
Gas pressure 50kPa gas 1min no leakage.
5.7.2 Stop clamps should adopt the following colors to identify the intended use of the trocar.
a) Red. The need to distinguish between arteries and veins for the arterial side;
b) Blue. The need to distinguish between arterial and venous use on the venous side;
c) White. Time-division of no moving and veins.
5.8 inner cone connector
The end of the puncture device shall have a locking internal conical connector conforming to GB/T 1962.2.
5.9 Covers
The puncture needle and the inner conical joint of the trocar should have suitable protection sleeves. The protection sleeve should be firm, it should not fall off naturally, and it is easy to remove.
5.10 Anti-acupuncture protection device
If the puncture device has a protection device against needle sticks, the manufacturer shall provide instructions for use of the protection device against needle sticks.
6 Chemical requirements
6.1 Preparation of test solution
The trocars are connected in series to a total length of 4.5m, and the glass flask is connected into a circulatory system, 250mL of water is added, and the rest are the same as GB/T 14233.1-
2008 Table 1 Method 1 Preparation of test solution.
6.2 Reducing substances
When tested in accordance with method 5.2.2 of GB/T 14233.1-2008, the perforator test solution and blank solution consume potassium permanganate [c(1/5KMnO4)
The difference in volume of = 0.01 mol/L] should not exceed 2.0 mL.
6.3 Metal ions
6.3.1 When inspected by atomic absorption spectrophotometry (AAS) according to 5.9.1 of GB/T 14233.1-2008, the trocar
The total content of barium, chromium, copper, lead and tin should not exceed 1 μg/mL. The content of cadmium should not exceed 0.1 μg/mL.
6.3.2 When tested according to the method 5.6.1 of GB/T 14233.1-2008, the color of the trocar inspection fluid should not exceed the mass concentration
ρ(Pb2)=1 μg/mL standard control.
6.4 pH
When tested in accordance with the method 5.4.2 of GB/T 14233.1-2008, any standard solution required for graying the indicator should not exceed
1mL.
6.5 Evaporation residue
When tested according to the method of 5.5 in GB/T 14233.1-2008, the total amount of evaporation residues should not exceed 5 mg.
6.6 UV absorbance
When tested according to the method of 5.7 in GB/T 14233.1-2008, the absorbance of the puncture test solution in the range of 250 nm to 320 nm should not be
Greater than 0.1.
6.7 Ethylene Oxide Residues
When testing according to Chapter 9 or Chapter 10 of GB/T 14233.1-2008, the residual amount of ethylene oxide per trocar should not be greater than
0.5mg.
7 Biological Requirements
7.1 Biocompatibility
The puncture device should be evaluated biologically according to the requirements of GB/T 16886.1.
7.2 Asepsis
The puncture device should undergo a confirmed sterilization process to make the product sterile.
Note 1. Refer to the reference for suitable sterilization methods.
Note 2. GB/T 14233.2 specifies the sterility test method, but this method should not be used for factory inspection.
7.3 Bacterial endotoxin
When tested according to GB/T 14233.2, each puncture device shall be filled with no more than 10 mL of extraction medium, and the bacterial endotoxin content shall be less than
0.5EU/mL.
8 type inspection
8.1 Type test is a full-performance test.
8.2 In the type test, if there is no special requirement, the physical requirements shall be randomly sampled 5 sets, and other requirements shall be tested according to the standard provisions. If all check
If all the inspection items are qualified, they are judged to be qualified, otherwise they are judged as unqualified.
9 signs
9.1 Initial packaging
The initial packaging should be marked with at least the following clearly identifiable information.
a) product name;
b) needle size and length;
c) Color labels should be marked unless the color of the product is visible through the initial packaging;
d) sterile, pyrogen-free, single-use;
e) Sterilization methods;
f) instructions for use and precautions, including warning instructions for "breakage of prohibited packaging" and "destruction after use";
g) lot number;
h) year o...