YY 0585.1-2019 (YY0585.1-2019) & related versions
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Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines
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YY 0585.1-2019: PDF in English
YY 0585.1-2019
YY
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0585.1-2005
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 1: Fluid lines
(ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for use
with pressure infusion equipment, MOD)
ISSUED ON: MAY 31, 2019
IMPLEMENTED ON: DECEMBER 1, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Materials ... 7
5 Physical requirements ... 7
6 Chemical requirements ... 8
7 Biological requirements ... 8
8 Packaging ... 8
9 Labelling ... 8
10 Disposal ... 10
Appendix A (Normative) Physical test ... 11
Appendix B (Normative) Chemical test ... 12
Appendix C (Normative) Storage volume ... 13
Appendix D (Informative) Technical differences between this part and ISO 8536-9:
2015 and their reasons ... 16
References ... 18
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 1: Fluid lines
1 Scope
This part of YY 0585 specifies the physical, chemical, and biological requirements for
single-use sterile fluid lines for pressure infusion equipment.
This part applies to single-use sterile fluid lines for pressure infusion equipment with a
maximum pressure of 200 kPa, including:
a) Syringe pump lines (SPL);
b) Connecting lines (CL);
c) Lines integrated with the injection cannula (LIC).
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
GB/T 1962.21 ) Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001, ISO 594-
2:1998, IDT)
GB 8368 Infusion sets for single use - Gravity feed (GB 8368-2018, ISO 8536-4:
2010, MOD)
GB 15811 Sterile hypodermic needles for single use (GB 15811-2016, ISO 7864:
1993, NEQ)
GB 18671 Intravenous needles for single use
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements (YY/T
0466.1-2016, ISO 15223-1: 2012, IDT)
1) GB/T 1962 will be replaced by Part 7 of YY/T 0916 series standard (ISO 80369-7: 2015, IDT).
1 --- patient;
2 --- occlusion;
3 --- tube;
4 --- bolus volume;
5 --- syringe pump.
Figure 1 -- Bolus volume
4 Materials
The materials from which the fluid lines are manufactured shall meet the requirements
specified in Chapter 5, Chapter 6, and Chapter 7.
5 Physical requirements
5.1 Transparency
The tubing of fluid lines shall be transparent. When the test is carried out according to
the provisions of A.1 in Appendix A, the interface between water and air shall be able
to be detected.
5.2 Particulate contamination
The fluid lines shall be manufactured with minimal particulate contamination. Fluid
pathway surfaces shall be smooth and clean. When the test is carried out according to
A.2, the pollution index shall not be exceeded.
5.3 Connection strength
When the test is carried out in accordance with the provisions of A.3, all parts of the
fluid lines (except the protective cover) shall be able to withstand a static tensile force
of at least 15 N for 15 s.
5.4 Leakage
Before the test starts, the entire system shall be conditioned at the test temperature.
The fluid lines shall be impermeable to air, microorganisms and fluid. When the test is
carried out according to A.4, there shall be no air or water leakage.
5.5 Adapters with female and/or male conical fittings
Before the test starts, the entire system shall be conditioned at the test temperature.
The adapters shall have female and/or male conical fittings in accordance with GB/T
1962.2.
5.6 Accessories
The accessories of the fluid lines, other than the infusion filter, shall meet the
requirements specified in YY 0585.2.
5.7 Filters
The infusion filters shall meet the requirements specified in YY 0585.3.
5.8 Storage volume
The storage volume shall be in accordance with stated in 9.2 i).
5.9 Injection needles
When the test is carried out according to A.5, the intravenous infusion needles,
intravenous catheters, or injection needles shall comply with GB 18671, YY 1282, or
GB 15811 respectively.
5.10 Protective caps
GB 8368 is applicable.
6 Chemical requirements
GB 8368 is applicable, and the test method is shown in Appendix B.
7 Biological requirements
GB 8368 is applicable.
8 Packaging
GB 8368 is applicable.
9 Labelling
9.1 General rules
Labels shall comply with the provisions of 9.2 and 9.3. If graphic symbols are used, the
regulations of YY/T 0466.1 shall be referred to.
Note: The symbol 2725 of ISO 7000 can be used to indicate the presence of a substance of concern, and
the method is to replace “×××” with the abbreviation of the substance; if the substance of concern is not
contained, a cross can be drawn on the symbol.
9.2 Single package
A single package shall be labeled with at least the following information:
a) The manufacturer’s name and address;
b) Text description of the contents, such as single-use cannula fluid lines;
c) There is no pyrogen in the fluid line, or no bacterial endotoxin in the fluid line;
d) The graphic symbols given in YY/T 0466.1 are used to indicate that the fluid line
is sterile;
e) Lot number that begins with the word “LOT”, or indicated by the graphic symbol
of YY/T 0466.1;
f) The expiration date (month/year) represented by the corresponding text or the
graphic symbols given in YY/T 0466.1;
g) The fluid line is for single use only that is indicated by the description of the
equivalent text, or the graphic symbol conforming to YY/T 0466.1;
h) Instructions for use, including warnings, such as checking whether the protective
cap has fallen off (the instructions for use can also be in the form of inserts);
i) The storage volume shall be marked according to C.3;
Note: For the definition of storage volume and the test method for measuring storage volume, see
Appendix C.
j) The letter “P” that represents pressure, and the size of which shall stand out from
the surrounding text.
If the single package area is too small to give all the information and/or symbols, the
information can be simplified to e) and f). In this case, the information required by this
clause shall be given on the label of the next larger shelf or multi-unit package.
9.3 Shelf or multi-unit package
The shelf or multi-unit package shall be labeled with at least the following information:
a) The manufacturer’s name and address;
b) Text description of the contents, such as single-use cannula fluid lines;
Appendix A
(Normative)
Physical test
A.1 Transparency test
Fill the fluid line with distilled water, and check visually whether the interface between
water and air is visible.
A.2 Particulate contamination test
The volume of the rinse fluid shall be at least 50 times the volume of the inner cavity
of the test sample, and the test shall be carried out in accordance with the provisions of
GB 8368.
A.3 Connection strength test
The tested fluid line shall be subjected to an axial static tensile force of 15 N for 15 s.
Inspect whether each connection can withstand the applied force.
A.4 Leakage test
A.4.1 Before starting the test, place the entire system at the test temperature for
conditioning.
A.4.2 Use the male and/or female adapters that are in accordance with GB/T 1962.2 to
seal each port of the fluid line, connect it with the compressed air source, apply air
pressure of 50 kPa to the fluid line for 15 s, and check whether the fluid line has air
leakage in the water at (40±1) ℃.
A.4.3 Fill the fluid line with distilled water at (40±1) ℃, and apply air pressure of 200
kPa for 15 min to check whether there is water leakage.
A.5 Injection needles
The needles shall be tested according to GB 18671, YY 1282, or GB 15811 respectively.
......
| Standard ID | YY 0585.1-2019 (YY0585.1-2019) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 14,132 | | Date of Issue | 2019 | | Date of Implementation | 2020-12-01 | | Summary | This standard specifies the physical, chemical and biological requirements for single-use sterile fluid paths for pressure infusion equipment. This standard applies to single-use sterile liquid circuits for pressure infusion equipment with a maximum pressure of 200kPa, including: syringe pump pipeline (SPL); connecting pipeline (CL); pipeline integrated with the injection cannula (LIC) . |
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