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Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories
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YY 0585.2-2019
YY
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replace YY 0585.2-2005
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 2: Accessories
(ISO 8536-10: 2015, 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 Materials ... 6
4 Physical requirements ... 6
5 Chemical requirements ... 7
6 Biological requirements ... 7
7 Packaging ... 7
8 Labelling ... 7
9 Disposal ... 9
Appendix A (Normative) Physical test ... 10
Appendix B (Normative) Chemical test ... 12
Appendix C (Normative) Biological test ... 13
Appendix D (Informative) Technical differences between this part and ISO 8536-10:
2015 and their reasons ... 14
References ... 16
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 2: Accessories
1 Scope
This part of YY 0585 specifies the physical, chemical, and biological requirements for
accessories used with pressure infusion equipment.
This part applies to accessories for single-use sterile fluid lines and accessories for
pressure infusion equipment specified in YY 0286.4, including:
a) Two-way stopcock (2SC), three-way stopcock (3SC), four-way stopcock (4SC)
and stopcocks manifold (SM);
Note: The labelling of the stopcock depends on the number of connections. The number of possible
functional positions can be indicated by the addition of a supplementary note, as expressed by a slash
and the number of possible positions of the stopcock. For example, a 3/4-way stopcock means a three-
way stopcock with 4 possible positions.
b) Units with injection sites (UIS) or units with check valves (UCV);
c) Stoppers (S) or adapters (A).
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)
YY 0286.4 Special infusion sets-Part 4:Single-use infusion equipment for use with
pressure infusion apparatus (YY 0286.4-2006, ISO 8536-8: 2004, IDT)
1) [Translator note: Copied from YY 0585.1-2019] GB/T 1962 will be replaced by Part 7 of YY/T 0916 series
standard (ISO 80369-7: 2015, IDT).
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)
YY 0585.4 Fluid lines for use with pressure infusion equipment and accessories for
single use - Part 4: Check valves (YY 0585.4-2009, ISO 8536-12: 2007, MOD)
Pharmacopoeia of the People’s Republic of China
3 Materials
The materials from which accessories are manufactured shall meet the requirements
specified in Chapter 4, Chapter 5, and Chapter 6.
4 Physical requirements
4.1 Avoidance of air bubbles
All components of accessories shall be designed so that no air bubbles are detected in
flow channels when they are tested in accordance with A.1 of Appendix A.
4.2 Particulate contamination
The accessories 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.
4.3 Connection strength
When the test is carried out in accordance with the provisions of A.3, the accessories
and the connections between all components (except the protective cover) shall be able
to withstand a static tensile force of not less than 15 N for 15 s.
For stopcocks, the connections between the plug and the housing shall be able to
withstand the tensile force regardless of the position of the plug.
4.4 Leakage
The accessories shall be impermeable to air, microorganisms and fluid. No matter where
the plug is located, it shall be sealed. When the test is carried out according to A.4, there
shall be no air or water leakage.
4.5 Adapters with female and/or male conical fittings
The adapters shall have female conical fittings and/or male conical fittings in
8.2 Single package
A single package shall be labelled with at least the following information:
a) The manufacturer’s name and address;
b) Text description of the contents, such as single-use stopcocks manifold;
c) The accessories are pyrogen-free, or the accessories are free of bacterial
endotoxins;
d) The graphic symbols given in YY/T 0466.1 are used to indicate that the
accessories are 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 accessories are 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;
i) 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.
8.3 Shelf or multi-unit package
The shelf or multi-unit package shall be labelled with at least the following information:
a) The manufacturer’s name and address;
b) Text description of the contents, such as single-use stopcocks manifold;
c) Lot number that begins with the word “LOT”, or indicated by the graphic symbol
of YY/T 0466.1;
d) The expiration date (month/year) represented by the corresponding text or the
graphic symbols given in YY/T 0466.1;
e) The text “Safe for use with pressure infusion equipment”;
Appendix A
(Normative)
Physical test
A.1 Air bubbles
Fill the accessory to be tested with distilled water according to the usual operation
method, and visually check whether there are air bubbles in the fluid pathway of the
transparent components.
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 accessory to be tested shall be subjected to an axial static tensile force of 15 N for
15 s. The same tensile force is also applied in the direction of the rotation axis of the
stopcock’s plug body. Inspect whether the connections of the components 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 accessory, connect it with the compressed air source, apply air
pressure of 50 kPa to the accessory for 15 s, and then check whether the accessory has
air leakage in the water at (40±1) ℃.
A.4.3 Fill the accessory 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 Stopcock manipulation test
Rotate the plug body to all functional positions and check for adverse effects on
adjacent components or incorrect adjustment of the plug body movement.
A.6 Test for units with injection sites
Appendix B
(Normative)
Chemical test
B.1 Preparation of test solution
Take components with a total area of 100 cm2. Disassemble the components that are in
contact with the fluid line in the sterilized and ready-to-use accessory, and arrange them
according to the same material.
Disintegrate each component so that its inner and outer surfaces can be soaked in water,
and put them into a 250 mL wide-mouth flask; add 200 mL of purified water that is in
accordance with the specification of the current version of “Pharmacopoeia of the
People’s Republic of China”, cover the flask, and place it at (37±1) ℃ for 24 h.
Take another 250 mL wide-mouth flask, add 200 mL of purified water that is in
accordance with the specification of the current version of “Pharmacopoeia of the
People’s Republic of China”, cover it, and place it at (37±1) ℃ for 24 h. This fluid is
used as the blank control fluid for the test carried out according to GB 8368.
B.2 Test procedure
The test shall be carried out in accordance with the provisions of GB 8368, but the test
solution specified in B.1 shall be used.
......
YY 0585.2-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0585.2-2005 / ISO 8536-10.2004
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 2. Accessories
(ISO 8536-10.2004, Infusion equipment for medical use – Part 10.
Accessories for fluid lines for use with pressure infusion equipment, IDT)
ISSUED ON. DECEMBER 07, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Designation ... 5
4 Materials ... 6
5 Physical requirements ... 6
6 Chemical requirements ... 7
7 Biological requirements ... 7
8 Packaging ... 7
9 Labelling ... 7
Annex A (Normative) Physical tests ... 10
Annex B (Normative) Chemical tests ... 12
Annex C (Normative) Biological tests ... 13
Bibliography ... 14
Fluid lines for use with pressure infusion equipment
and accessories for single use - Part 2. Accessories
1 Scope
This Part of YY 0585 applies to sterilized accessories for single use in fluid lines and
pressure infusion equipment as specified in YY 0286.4.
This Part of YY 0585 includes.
a) Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC)
and stopcocks manifold (SM);
NOTE. Designation of a stopcock depends on the number of connections. The number of possible
functional positions can be expressed by addition of a complementary note, using a diagonal
stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock
for three-way stopcock with four possible positions.
b) units with injection site (UIS) or check valve (UCV);
c) stoppers (S) or adapters (A).
2 Normative references
The articles contained in the following documents have become part of this Part of YY
0585 when they are quoted herein. For the dated documents so quoted, all the
modifications (excluding corrections) or revisions made thereafter shall not be applicable
to this Part. For the undated documents so quoted, the latest editions shall be applicable
to this Part.
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 1962.2-2001, idt ISO 594-2.1994)
GB 15810 Sterile hypodermic syringes for single use - Part 1. Syringes for manual use
(GB 15810-2001, eqv ISO 7886-1.1993)
GB 8368 Infusion sets for single use - Gravity feed (GB 8368-2005, ISO
8536-4.2004, MOD)
YY 0286.4 Special infusion sets - Part 4. Single-use infusion equipment for use with
pressure infusion apparatus (YY 0286.4-2006, ISO 8536-8.2004, IDT)
Bibliography
[1] GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for
interactions with blood (GB/T 16886.4-2003, ISO 10993-4, IDT)
[2] GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical
use - Part 2.Biological test methods
[3] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
[4] GB 18279-2000, Medical devices - Validation and routine control of ethylene oxide
sterilization (idt ISO 11135.1994)
[5] GB 18280-2000, Sterilization of health care products - Requirements for validation
and routine (idt ISO 11137.1995)
[6] GB/T 6682-1992, Water for analytical laboratory use - Specification and test methods
(neq ISO 3696.1997)
[7] Chinese Pharmacopoeia
[8] ISO 31-3 Quantities and units - Part 3. Mechanics
......
| Standard ID | YY 0585.2-2019 (YY0585.2-2019) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,147 | | Date of Issue | 2019 | | Date of Implementation | 2020-12-01 | | Summary | This standard specifies the physical, chemical and biological requirements for accessories used in pressure infusion equipment. This standard applies to disposable sterile liquid circuits and accessories for pressure infusion sets specified in YY 0286.4, including: two-way switch (2SC), three-way switch (3SC), four-way switch (4SC) and multiple switch (SM ); unit with injection (UIS) or unit with backflow prevention valve (UCV); plug (S) or connector (A). | | Standard ID | YY 0585.2-2005 (YY0585.2-2005) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 9,916 | | Date of Issue | 2005-12-07 | | Date of Implementation | 2006-12-01 | | Adopted Standard | ISO 8536-10-2004, IDT | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | Industry Standard Notice 2006 No. 2 (No. 74 overall) | | Proposing organization | National Standard Committee on Medical Infusion Equipment | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to single-use sterile fluid path and YY 0286. 4 predetermined pressure infusion Used accessories. YY 0585 This part includes: a) two-way switch (2SC), three-way switch (3SC), four digital (4SC) and multi Switch (SM), b) seat with injection device (UIS) or with backflow preventer devices (UCV), c) plug (S) or connector (A). |
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