YY/T 1282-2022 PDF English
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| YY/T 1282-2022 | English | 320 |
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Intravenous catheter for single use
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| YY 1282-2016 | English | 145 |
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Intravenous catheter for single use
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YY/T 1282-2022: Intravenous catheter for single use---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/YYT1282-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
CCS C 31
Replacing YY 1282-2016
Intravenous catheter for single use
Issued on: MAY 18, 2022
Implemented on: JUNE 01, 2023
Issued by. National Medical Products Administration
Table of Contents
Foreword... 4
Introduction... 5
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 7
4 Structure... 8
5 Physical requirements... 8
5.1 Particulate contamination... 8
5.2 Specifications... 8
5.3 Catheter unit... 9
5.3.1 Outer surface... 9
5.3.2 Matching... 9
5.3.3 Bending resistance... 10
5.3.4 Peak tensile force... 10
5.3.5 Connection strength... 11
5.3.6 Infusion port... 11
5.3.7 Multi-way stopcock... 11
5.3.8 Extension tube... 11
5.3.9 Blocking device... 11
5.4 Needle unit... 12
5.4.1 Needle tube... 12
5.4.2 Needle tip... 12
5.4.3 Connection strength... 12
5.5 Lubricant... 12
5.6 Flow rate... 12
5.7 Venting... 12
5.8 Flashback... 13
5.9 No leakage... 13
5.10 Adhesion... 13
5.11 Corrosion resistance... 13
5.12 Radiographic detectability... 13
5.13 Protective piece... 14
5.14 Anti-needlestick protection device... 14
6 Chemical requirements... 14
7 Biological requirements... 14
7.1 Biocompatibility... 14
7.2 Sterility... 14
7.3 Bacterial endotoxins... 14
8 Marks... 15
Intravenous catheter for single use
1 Scope
This document specifies the requirements for intravenous catheter for single use
(hereinafter referred to as "intravenous catheter") for insertion into the human body's
peripheral venous system for infusion or blood transfusion, to ensure compatibility with
corresponding infusion and blood transfusion equipment.
This document applies to the intravenous catheter inserted into the human body's
peripheral venous system for infusion or blood transfusion.
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 1962.2, 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 8368, Infusion sets for single use -- Gravity feed
GB/T 14233.2-2005, 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 --
Requirements and test methods
GB/T 19633.1, Packaging for terminally sterilized medical devices -- Part 1.
Requirements for materials, sterile barrier systems and packaging systems
YY 0285.1-2017, Intravascular catheters -- Sterile and single-use catheters -- Part
1.General requirements
YY 0285.5-2018, Intravascular catheters -- Sterile and single-use catheters -- Part
5.Over-needle peripheral catheters
YY 0581.1-2011, Infusion access adapters. Part 1.Needle access adapters (Heparin
plugs)
YY 0581.2-2011, Infusion access adapter. Part 2.Needleless access adapters
YY 0585.2-2019, Fluid lines for use with pressure infusion equipment and
accessories for single use -- Part 2.Accessories
YY/T 0615.1, Requirements for medical devices to be designated “STERILE”. Part
1.Requirements for terminally sterilized medical devices
ISO 23908, Sharps injury protection -- Requirements and test methods -- Sharps
protection features for single-use hypodermic needles, introducers for catheters and
needles used for blood sampling
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 distal end
The last part that the catheter is inserted into the patient's vein as far as possible.
3.2 outside diameter of the catheter
The maximum outer diameter of the catheter.
3.3 effective length of the catheter
The maximum length the intravenous catheter can be inserted into a patient's vein.
NOTE. See l in Figure 1 of YY 0285.1-2017.
3.4 infusion port
The interface intended to be connected to infusion, transfusion or injection equipment.
NOTE. Generally, there are 6% Luer conical connectors, puncture connectors (heparin caps),
needle-free interface connectors (including positive pressure types), etc.
3.5 multi-way stopcock
An assembly that can open a certain passage while closing all other passages, thereby
achieving switching between multiple passages.
3.6 vent fitting
A connector used to expel gas and limit or better prevent blood flow, divided into fixed
and movable types.
3.7 extension tube
A pipeline in which one end of the intravenous catheter is connected to the catheter seat,
and the other end is connected to the infusion port.
3.8 catheter unit
An assembly consisting of the catheter, catheter hub, extension tube (if any), and any
integral connectors.
3.9 needle unit
An assembly consisting of a needle barrel and needle hub and/or any integral
accessories.
3.10 flashback
Blood flows into the needle hub or catheter.
3.11 high-pressure angiographic catheter
An intravenous catheter for injecting contrast medium into a peripheral vein.
4 Structure
A typical intravenous catheter consists of two parts. a catheter unit and a needle unit.
5 Physical requirements
5.1 Particulate contamination
When tested according to Annex A, the contamination index of the intravenous catheter
should not exceed 90.
5.2 Specifications
5.2.1 The outer diameter of the catheter of the intravenous catheter shall comply with
the requirements of Table 1.The catheter unit shall have a color code in accordance
with the requirements of Table 1.
When the blocking device is in the blocking state, a hydraulic pressure of 20 kPa is
passed through it for 15 s and no liquid should pass through.
5.4 Needle unit
5.4.1 Needle tube
If steel pipes are used, they should comply with the requirements of GB/T 18457.
5.4.2 Needle tip
When examined with normal or corrected vision at 2.5 times magnification, the needle
tip should be sharp, without curling, notches or hooks.
NOTE 1.Annex C of YY 0285.5-2018 gives examples of typical needle tip geometries.
NOTE 2.Annex B provides a method for evaluating the puncture performance of an intravenous
catheter and catheter when they are in harmony.
5.4.3 Connection strength
When tested according to Annex A of YY 0285.5-2018, the needle tube should not be
loose in the needle seat.
5.5 Lubricant
If catheters and needles are lubricated, there should be no visible accumulation of
lubricant on the outer surfaces of the catheters and needles as observed with normal or
corrected vision.
5.6 Flow rate
When tested according to Annex E of YY 0285.1-2017, the flow rate of a conduit with
a nominal outer diameter less than 1.0 mm should be no less than 80% of the
manufacturer's nominal value. The flow rate of a conduit with a nominal outer diameter
greater than or equal to 1.0 mm should be no less than 90% of the manufacturer's
nominal value.
5.7 Venting
If the intravenous catheter has a vent fitting, when tested according to Annex D of YY
0285.5-2018, there should be no liquid leakage from the vent fitting within 15 s.
5.13 Protective piece
The catheter end of the intravenous catheter and the Luer taper connector should have
a protective piece. The protective piece should be firm but easy to remove.
5.14 Anti-needlestick protection device
The intravenous catheter should be equipped with anti-needlestick protection devices.
If there is an anti-needlestick protection device, it should comply with the requirements
of ISO 23908.
6 Chemical requirements
When testing the test solution prepared in Annex F according to the method specified
in GB 8368, it shall comply with the requirements of GB 8368.
7 Biological requirements
7.1 Biocompatibility
Intravenous catheters should be subjected to biological evaluation according to the
requirements of GB/T 16886.1.The evaluation results should indicate that they are free
of biological hazards.
7.2 Sterility
The sterility of intravenous catheters should comply with the requirements of YY/T
0615.1.
7.3 Bacterial endotoxins
When testing according to Chapter 4 of GB/T 14233.2-2005, use an endotoxin-free
syringe to draw 5 mL of extraction medium and connect it to an indwelling catheter.
Inject the solution into the lumen of the intravenous catheter until full, then seal the
distal end of the catheter. Place the syringes together in a 37°C incubator and allow
them to incubate for 1 h. Push the remaining extraction medium in the syringe through
the lumen of the intravenous catheter. Cut the catheter at the base. Place the cut catheter
in the collection solution. Place the syringe in a 37°C incubator and incubate for 1 h.
Collect the entire extract for testing. The bacterial endotoxin limit should be less than
0.5 EU/mL.
NOTE. YY/T 0618 provides Test methods for bacterial endotoxins of medical devices - Routine
monitoring and alternatives to batch testing.
8 Marks
8.1 Product marks
High-pressure angiographic catheters should be marked with a high-pressure resistance
mark.
NOTE. Words or colors such as "High pressure resistant" or "P" can be used for identification.
8.2 Single packaging mark
At least the following clearly identifiable information should be provided on the single
package.
a) Description of contents (name, catheter outer diameter and length, etc.);
b) For single use only, or equivalent;
c) Sterility;
d) Method of sterilization;
e) Radiopaque, if applicable;
f) Color code, unless the product's color code is visible through the individual
packaging;
g) Batch number;
h) Date of manufacture, expiration date, or date of expiration;
i) Nominal flow rate;
j) Maximum nominal pressure for high-pressure angiographic catheter;
k) Manufacturer's name and address.
NOTE 1.The graphic symbols given in YY/T 0466.1 can be used to meet the above requirements.
NOTE 2.ISO 7000 symbol 2725 can be used to indicate the presence of a substance of concern by
replacing "XXX" with the abbreviation of the substance. If the substance of concern is not present,
a cross is placed on the symbol.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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