YY/T 0286.4-2020_English: PDF (YY/T0286.4-2020)
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Special infusion sets -- Part 4: Infusion sets for single use with pressure infusion apparatus
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| Standard ID | YY/T 0286.4-2020 (YY/T0286.4-2020) | | Description (Translated English) | Special infusion sets -- Part 4: Infusion sets for single use with pressure infusion apparatus | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 18,112 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Drafting Organization | Shandong Medical Device Product Quality Inspection Center, Termao Medical Products (Hangzhou) Co., Ltd., Wuhan Zhixun Chuangyuan Technology Development Co., Ltd., Jiangsu Yakai Medical Technology Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd. | | Administrative Organization | National Standardization Technical Committee for Medical Infusion Devices (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Standard ID | YY 0286.4-2006 (YY0286.4-2006) | | Description (Translated English) | Special infusion sets - Part 4: Single-use infusion equipment for use with pressure infusion apparatus | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 13,111 | | Date of Issue | 2006-04-19 | | Date of Implementation | 2007-04-01 | | Quoted Standard | GB/T 1962.2; GB 8368; YY 0466; GB 9706.27 | | Adopted Standard | ISO 8536-8-2004, IDT | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | National Technical Committee of Standardization for medical infusion | | Regulation (derived from) | SFDA [2006] No. 157 | | Proposing organization | National Standardization Technical Committee appliances Infusion | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the following sterile supply for 200kPa pressure infusion equipment Disposable Infusion (hereinafter referred to as: Infusion) requirements. |
YY/T 0286.4-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0286.4-2006
Special infusion sets - Part 4: Infusion sets for single use with
pressure infusion apparatus
(ISO 8536-8:2015, Infusion equipment for medical use - Part 8: Infusion sets for
single use with pressure infusion apparatus, MOD)
ISSUED ON: JUNE 30, 2020
IMPLEMENTED ON: JUNE 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 General requirements ... 7
5 Materials ... 11
6 Physical requirements ... 11
7 Chemical requirements ... 13
8 Biological requirements ... 13
9 Packaging ... 13
10 Labels ... 13
11 Disposal ... 14
Appendix A (Normative) Physical test ... 16
Appendix B (Normative) Storage volume ... 17
Appendix C (Informative) Technical differences between this Part and ISO 8536-
8:2015 and reasons ... 20
References ... 22
Special infusion sets - Part 4: Infusion sets for single use with
pressure infusion apparatus
1 Scope
This Part of the "Specialized infusion sets" series of standards specifies the
requirements for sterile supplied disposable infusion sets (hereinafter referred to as
"infusion sets"), for infusion equipment which has a pressure of 200 kPa and below.
This Part applies to disposable infusion sets of infusion equipment, which has a pressure
of 200 kPa and below.
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 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001, ISO
594-2:1998, IDT)
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-
4:2004, MOD)
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)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Filling volume
VF
The pipeline is full filled under gravity, whilst the pipeline remains pressure-free.
Note: The filling volume is equal to the calculated volume of the pipeline.
3.2
Bolus volume
VB
The increased volume of the pipeline volume after pressurization (VS), as compared
with the pipeline volume without pressure (VF).
Note: See Figure 1 for a graphic representation of bolus volume.
3.3
Storage volume
VS
The volume of the pipeline under pressure, which is the sum of the filling volume
(VF) and the bolus volume (VB).
VS = VF + VB
4 General requirements
4.1 The names of the infusion set assembly and the separate air intake assembly are as
shown in Figure 2, Figure 3, Figure 4. These illustrations represent the structure of the
infusion set and air intake device. Other structures may be used, as long as the same
effect can be achieved. The infusion set as shown in Figure 3 is suitable for use in bag-
type plastic containers. The infusion set shown in Figure 3, which has the separate air
inlet device as shown in Figure 4, OR the infusion set shown in Figure 2, is suitable for
rigid containers.
4.2 The infusion set shall have a protective sheath, to keep the inside of the infusion set
sterile before use. The cork piercer or needle of the gas inlet device shall have a
protective sheath.
When testing according to A.3.2 and A.3.4, there shall be no air or water leakage. When
testing according to A.3.3, no air shall enter.
6.4 Male conical joint
The male conical joint shall comply with the requirements of GB/T 1962.2.
6.5 Injection piece
The injection piece shall be able to inject into the pipeline. When testing according to
A.4, water leakage shall not exceed one drop. The injection piece shall be located at the
accessory of male conical joint.
6.6 Liquid filter
GB 8368 is applicable.
6.7 Infusion flow rate
GB 8368 is applicable.
6.8 Bottle cork piercer
GB 8368 is applicable.
6.9 Air intake devices
GB 8368 is applicable.
6.10 Burette and dropper
GB 8368 is applicable.
6.11 Pipeline
Pipelines made of flexible materials shall be transparent or sufficiently transparent, so
that the interface between water and air can be distinguished with normal or corrected
vision, when air bubbles pass through.
The length of the pipeline, from the end to the dropper (including the injection piece (if
any) and the male conical joint), shall be not less than 1500 mm.
6.12 Flow regulator
GB 8368 is applicable.
6.13 Protective sheath
GB 8368 is applicable.
f) Expiration date (year and month), appended with appropriate text, OR using
graphic symbols consistent with YY/T 0466.1;
g) Indication that the infusion set is for one-time use only, OR equivalent words, OR
use of graphic symbols that comply with YY/T 0466.1;
h) Instructions for use, including warnings, such as about the protective sheath
falling off (the instructions for use can also be in the form of inserts);
i) The liquid storage volume is marked according to B.3. If supporting pressure
infusion equipment is specified, the manufacturer shall give the name and type of
pressure infusion equipment;
j) The letter "p" indicating pressure shall be larger than the surrounding text;
k) Instructions that 20 drops or 60 drops of distilled water, which is dropped from
the burette, are equal to (1 ± 0.1) mL or (1 ± 0.1) g.
If the single packaging area is too small to give all information and/or symbols, the
information can be simplified to e) and f). In this case, the information required by this
Article shall be given on the next larger shelf or on the label of the multi-unit packaging.
10.3 Shelf or multi-unit packaging
The shelf or multi-unit packaging shall have at least the following information:
a) Manufacturer’s name and address;
b) Text describing the contents;
c) The batch number, which starts with the word "LOT", or uses of the graphic
symbol specified in YY/T 0466.1;
d) Expiration date (year and month), appended with appropriate text, or use of
graphic symbols consistent with YY/T 0466.1;
e) Instructions for use, including warnings, such as regarding the protective sheath
falling off (the instructions for use may also be in the form of inserts);
f) The letter "p" indicating pressure shall be larger than the surrounding text;
g) Storage requirements.
11 Disposal
Information on the safe and environmentally sound disposal of disposable infusion sets
shall be given, in the accompanying documentation.
Appendix A
(Normative)
Physical test
A.1 Particulate contamination test
GB 8368 is applicable.
A.2 Connection strength test
The tested infusion set is subjected to an axial static tension force of 15 N for 15 s.
Verify whether the infusion set can withstand the applied force.
A.3 Leakage test
A.3.1 At the beginning of the test, condition the entire system at the test temperature.
A.3.2 Connect the infusion set to the air source. Seal all other ports. Fill the infusion set
with 50 kPa air pressure, at (40 ± 1) °C for 15 seconds. Place the infusion set in water.
Check whether there is any air leakage.
A.3.3 Fill the infusion set with water. Seal each port. Connect it to a vacuum device.
Vacuum to -20 kPa at (40 ± 1) °C. Maintain it for 15 seconds. Check whether there is
air entering the infusion set.
If the infusion set has a flow element, this test is only applicable to the part above the
flow element of the infusion set; if there is no flow element, this test is applicable to the
entire infusion set.
A.3.4 Apply a pressure of 200 kPa to the flow element of the infusion set and the water-
filled part below, in an environment of (40 ± 1) °C, for 15 minutes. If supporting
pressure infusion equipment is specified, the maximum working pressure of the
pressure infusion equipment shall be applied.
Note: If the infusion set has no flow element, under the same environment, check the entire
pipeline under the dropper.
A.4 Injection piece test
The test is carried out according to the provisions of GB 8368, BUT under the internal
pressure of 200 kPa.
A.5 Filtration rate test of chemical liquid filter
GB 8368 is applicable.
......
YY 0286.4-2006
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0286.4-2006 / ISO 8536-8.2004
Special infusion sets - Part 4. Single-use
infusion equipment for use with pressure
infusion apparatus
(ISO 8536-8.2004, Infusion equipment for medical use –
Part 8. Infusion equipment for use with pressure infusion apparatus, IDT)
ISSUED ON. APRIL 19, 2006
IMPLEMENTED ON. APRIL 1, 2007
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
5 Materials ... 9
6 Physical requirements ... 9
7 Chemical requirements ... 10
Annex A (Normative) Physical tests ... 13
Annex B (Normative) Chemical tests ... 15
Annex C (Normative) Biological tests ... 16
Annex NA (Informative) Test Method for Storage Volume ... 17
Bibliography ... 19
Introduction
With the ever developing infusion techniques and increasingly improved clinical
requirements, some dedicated infusion sets applicable to special clinical requirements
have appeared in succession. The YY 0286 standard is specifically devised to standardize
these dedicated infusion sets. As the development of infusion sets is endless, it is
impossible to expect to have every dedicated infusion set having special requirements
covered in one standard alone. Therefore, every part of YY 0286 works for only one
special clinical requirement to standardize these dedicated infusion sets. In case one
infusion set falls into these having various special purposes as well, it shall conform to the
applicable parts in YY 0286.
The storage volume involved in this Part of YY 0286 is an index to investigate the
compliance of an infusion set. When used with pressure infusion equipment, if the infusion
switch (if any) at the end is opened, the infusion set will, because of the action of the
pressure supplied by the infusion equipment, deliver excess liquid to the patient on the
instant the switch is opened. This may have an adverse effect on the patient.
The determination of storage volume shall undergo a test together with the suitable
pressure infusion equipment. This is a job that both infusion set manufacturers and
pressure infusion equipment shall do jointly.
The term “storage volume” in this Part of YY 0286 is “bolus volume” in English in GB
9706.27-2005. Such explanation is helpful to further learn the related contents in GB
9706.27-2005 (see also Annex NA).
The Annex NA in GB 8368 is applicable to this Part of YY0286.
Special infusion sets - Part 4. Single-use infusion equipment
for use with pressure infusion apparatus
1 Scope
This Part of YY 0286 gives users information on sterilized infusion sets for single use with
pressure infusion equipment (hereinafter referred to as infusion set) up to a maximum of
200 kPa.
2 Normative references
The articles contained in the following documents have become part of this Part of YY
0286 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 8368 Infusion sets for single use, gravity feed (GB 8368-2005, GB 8368-2005, ISO
8536-4.2004, MOD)
YY 0466 Medical devices - Symbols to be used with medical device labels labelling and
information to be supplied (YY 0466-2003, ISO 15223.2000, IDT)
GB 9706.27 Medical electrical equipment - Part 2-24. Particular requirements for the
safety of infusion pumps and controllers (GB 9706.27-2005, IEC 60601-2-24.1998, IDT)
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate
air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the
configuration of infusion sets and air-inlet devices; other configurations may be used
provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only
be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in
Figure 1 shall be used for rigid containers.
collection vessel shall be emptied.
NA.4 The switch is opened to gather the storage volume generated because of switch
closing before the pressure reduces to atmospheric pressure.
If the equipment instructions offer the methods of eliminating storage volume before the
infusion set is opened, the storage volume shall be first eliminated according to the
methods described in the instructions before the residual storage volume is measured.
Bibliography
[1] ISO 31-3 Quantities and units - Part 3. Mechanics
[2] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
[3] GB 18279-2000 Medical devices - Validation and routine control of ethylene oxide
sterilization (idt ISO 11135.1994)
[4] GB 18280-2000 Sterilization of health care products - Requirements for validation
and routine (idt ISO 11137.1995)
[5] GB/T 6682-1992 Water for analytical laboratory use - Specification and test methods
(neq ISO 3696.1997)
[6] YY 0451 Portable infusion devices for single use
[7] Chinese Pharmacopoeia
......
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