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GB 8368-2005 PDF in English


GB 8368-2005 (GB8368-2005) PDF English
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GB 8368-2005: PDF in English

GB 8368-2005
GB
ICS 11.040.20
C 31
National Standard
of the People’s Republic of China
Replacing GB 8368-1998
Infusion sets for single use, gravity feed
(ISO 8536-4.2004 Infusion equipment for medical use –
Part 4. Infusion sets for single use, gravity feed, MOD)
ISSUED ON. JULY 21, 2005
IMPLEMENTED ON. DECEMBER 1, 2005
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 General requirements ... 6 
4 Marks ... 9 
5 Materials ... 10 
6 Physical requirements ... 10 
7 Chemical requirements ... 13 
8 Biological requirements ... 14 
9 Labelling ... 14 
10 Packaging ... 16 
Appendix A ... 17 
Appendix B ... 23 
Appendix C ... 25 
Appendix NA ... 26 
Appendix NB ... 30 
Bibliography ... 32 
Foreword
This Standard modifies-adopts ISO 8536-4.2004 “Infusion equipment for
medical use – Part 4. Infusion sets for single use, gravity feed”. SEE Appendix
NB for the differences between this Standard and the adopted international
standard.
Compared with GB 8368-1998, this Standard has the following major technical
changes.
— The particulate contamination index and its test method eqivalently adopt
the international standard;
— ENHANCE the requirements for the leakage test;
— ENHANCE the requirements for the length of tubing;
— ADD the restrictions to the color of flow regulators;
— ENHANCE the requirements for the injection sites;
— The test method of pH value is modified from the “pH meter method” to
the “titration”;
— ADD the requirements that are not specified in the corresponding
international standard in the GB 8368-1998 to the Appendix NA
(Informative) Design and implementation guidance.
The special infusion sets specified in the standard of GB 18458 are not included
in the products involved in this Standard.
The Appendixes A, B and C of this Standard are normative, while the
Appendixes NA and NB are informative.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of the National Technical
Committee for Standardization of the Infusion Equipment for Medical Use.
This Standard was drafted by Shandong Quality Inspection Center for Medical
Devices.
Main drafters of this Standard. Wu Ping, Zhang Qiang, You Shaohua, Wang
Yanwei, and Qin Dongli.
The previous versions replaced by this Standard are as follows.
Infusion sets for single use, gravity feed
1 Scope
This Standard specifies the requirements for the gravity feed infusion sets for
single use, so as to ensure their compatibility with containers for infusion
solutions and intravenous equipment.
The second purpose of this Standard is to provide guidance on specifications
relating to the performance and quality of the materials used in the infusion sets,
and to present designations for infusion set components.
2 Normative references
The provisions in the following documents become the provisions of this
Standard through reference in this Standard. For dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, parties who reach an agreement based on this
Standard are encouraged to study if the latest versions of these documents are
applicable. For undated references, the latest versions apply to this Standard.
GB/T 1962.1 The conical fittings with a 6% (Luer) taper for syringes, needles
and certain other medical equipment – Part 1. General requirement (GB/T
1962.1-2001, idt ISO 594-1.1986)
GB/T 1962.2 The 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 594-2.1998)
GB/T 6682-1992 Water for analytical laboratory use – Specification and test
methods (neq ISO 3696.1987)
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical
use – Part 1. Chemical analysis methods
GB/T 14233.2 Infusion, transfusion, injection equipment for medical use –
Part 2. Biological test methods
GB 15811-2001 Sterile hypodermic needles for single use (eqv ISO
7864.1993)
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)
ISO 14644-1.1999 Cleanrooms and associated controlled environments –
Part 1. Classification of air cleanliness
3 General requirements
3.1 The nomenclature to be used for the components of infusion sets and of a
separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate
the configuration of infusion sets and air-inlet devices. Other configurations may
be used provided they lead to the same effect. The infusion sets as illustrated
in Figure 2 are applicable to the collapsible plastic containers. The infusion sets
as illustrated in Figure 2 equipped with separate air-inlet devices as illustrated
in Figure 3, OR the infusion sets as illustrated in Figure 1 are applicable to the
rigid containers.
3.2 The infusion sets shall be provided with protective caps, so as to keep the
inner parts of the infusion sets sterile before the application. The air-inlet
devices shall be provided with protective caps over the closure-piercing devices
or needles.
Air-inlet device GB 8368-AD
5 Materials
The materials from which the infusion sets and their components are
manufactured (as described in Article 3) shall comply with the requirements
specified in Article 6. For the infusion set components in contact with the
solution, the materials shall also comply with the requirements specified in
Articles 7 and 8.
6 Physical requirements
6.1 Particulate contamination
The infusion sets shall be manufactured under the condition of minimum
particulate contamination. The surface of the fluid channel shall be smooth and
clean. When tested as specified in Article A.1, the number of particles shall not
exceed the contamination index limit.
6.2 Leakage
When tested as specified in Article A.2, the infusion sets shall show no signs of
air leakage.
6.3 Tensile strength
When tested as specified in Article A.3, the connection between the
components of the fluid channels of infusion sets, excluding the protective caps,
shall withstand a static tensile force of not less than 15N for 15s.
6.4 Closure-piercing device
The dimensions of closure-piercing devices shall conform to the dimensions
shown in Figure 4.
Note. The dimension of 15mm in Figure 4 is a reference measurement. The cross-section of the piercing
device at this site is a circle.
The closure-piercing devices shall be capable of piercing and penetrating the
closures of the fluid containers without pre-piercing. No debris shall generate
during this procedure.
allowable to be less than 1,500mm in length. However, the length shall not be less than 1,250mm.
6.7 Fluid filter
Each infusion set shall be equipped with a fluid filter.
When tested as specified in Article A.5, the filtration rate of latex particles on
the filter shall not be less than 80%.
6.8 Drip chamber and drip tube
The drip chambers shall be used for continuous observation of liquid drops. The
liquid shall enter the drip chamber through a drip tube inserted in the drip
chamber. The distance from the end of the drip tube to the outlet of the drip
chamber shall not be less than 40mm, or the distance from the drip tube to the
fluid filter shall not be less than 20mm. The distance from the wall of the drip
chamber to the end of the drip tube shall not be less than 5mm. 20 or 60 drops
of distilled water coming out of the drip tube shall deliver a volume of (1 ± 0.1)
ml, or a mass of (1 ± 0.1) g at (23 ± 2) °C and at a flow rate of (50 ± 10) drops/min.
The drip chambers shall be conducive to the liquid filling process.
6.9 Flow regulator
The flow regulators shall be capable of adjusting the liquid flow from zero to the
maximum. The orange flow regulators shall not be applied to the gravity infusion
system. The flow regulators shall be continuously used during the entire
process of infusion without causing any damages to th...
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.