This part specifies the requirements for single-use burette infusion sets with nominal volumes of 50 mL, 100 mL, 150 mL and 200 mL to ensure compatibility with infusion containers and intravenous equipment. GB 18458.2-2003 Special infusion sets Part 2: Single-use burette infusion sets GB18458.2-2003 Standard download decompression password: www.bzxz.net

ICS 11.040.20
National Standard of the People's Republic of China
GB.18458.2—2003
Special infusion sets
Part 2:
Disposable burette infusion sets
Special infusion sets—Part 2 :Burette-type infusion sets for single use(ISO/DIS 8536-5:2000 Infusion equipment for medical usePart 5:Burette-type infusion sets sets, MOD)2003-06-13 issue
People's Republic of China
General Administration of Quality Supervision, Inspection and Quarantine
2004-01-01 implementation
GB18458 is titled as special infusion sets, including the following parts: - Part 1: Disposable precision filter infusion sets; - Part 2: Disposable burette infusion sets; - Part 3: Disposable light-shielded infusion sets. This part is Part 2 of GB18458.
Other parts of this standard will be formulated successively. GB18458.2—2003
This part of GB18458 is modified to adopt ISO/DIS8536-5:2000 "Medical infusion sets Part 5: Burette infusion sets" (English version). The main reason why they cannot be adopted as equivalent is that the referenced standard GB8368-1998 "Disposable Infusion Sets" is equivalent to the international standard ISO8536-4 "Medical Infusion Sets Part 4: Disposable Infusion Sets Gravity Infusion Type" referenced in the international standard. Taking into account my country's national conditions, this part has made some modifications when adopting ISO/DIS8536-5:2000. The relevant technical differences have been compiled into the text and marked with a vertical single line in the margins of the clauses they involve. Appendix A provides a list of these technical differences and their reasons for reference.
For ease of use, the following editorial modifications have been made to ISO/DIS8536-52000: a) The ISO foreword has been deleted;
b) Informative Appendix A has been added.
This part replaces YY0286-1996 "Disposable Burette Infusion Sets". This part will be abolished as of the date of implementation. Appendix A of this part is an informative appendix.
This part is proposed by the State Food and Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment. The drafting unit of this part: Shandong Medical Device Product Quality Inspection Center. The main drafters of this part: Wu Ping, Wang Yanwei, Song Jinzi, Luo Hongyu, Tian Qing. GB18458.2-2003
The infusion sets for infusion of large infusions (sodium chloride, glucose, amino acids, fat emulsions) described in GB8368 are generally used in conjunction with large-capacity parenteral infusion containers (such as glass bottles and plastic bags). The design of ordinary infusion sets can generally only estimate the infusion volume by the number of drops per milliliter of infusion indicated. Glass bottles and plastic containers also have only coarse scale intervals. When measuring and reading to the milliliter level, ordinary infusion sets are not accurate enough and are difficult to do.
The burette infusion sets described in this part are suitable for pediatric infusion and for situations where accurate monitoring of the infusion dose is required. It is best to have a shut-off valve in the burette, which can provide a guarantee for accurate control of the infusion dose. 1 Scope
Special infusion sets Part 2:
Disposable burette infusion sets
GB18458.2—2003
This part specifies the requirements for disposable burette infusion sets with nominal capacities of 50mL, 100mL, 150mL and 200mL to ensure compatibility with infusion containers and intravenous equipment. The second purpose of this part is to provide guidance on the quality and performance specifications of materials used in infusion sets. 2 Normative referencesbzxz.net
The provisions in the following documents become provisions of this part through reference in this part of GB18458. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to an agreement based on this part are encouraged to investigate whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this part.
GB8368—1998—Disposable infusion sets (eqvISO8536-4:1998) 3 General requirements
3.1 Typical burette infusion set components and terminology are shown in Figure 1. Note: Figure 1 illustrates the configuration of a burette infusion set. Other configurations may also be used if they can perform the same function. 3.2 The burette infusion set should be equipped with a protective cover to ensure that the interior is sterile before use. 4 Marking example
The marking of a burette-type (BT) infusion set (IS) with a nominal capacity of 100 mL that complies with the requirements of this standard is: Burette-type infusion set GB18458.2-BT-IS-1005 Materials
The materials used to produce burette-type infusion sets and their components (see Chapter 3) shall meet the requirements of Chapter 6. The components of burette-type infusion sets that come into contact with the solution shall also meet the requirements specified in Chapters 7 and 8. 6 Physical requirements
6.1 General
The physical requirements of burette-type infusion sets shall comply with the requirements of GB8368, except for the particulate content, and shall also comply with the requirements of 6.2 to 6.5. 6.2 Design
6.2.1 The burette shall be made of rigid or semi-rigid plastic material, and the liquid inside shall be visible through the wall. 6.2.2 There shall be an air inlet with an air filter above the scale on the top of the burette. 6.2.3 The burette should be able to receive the drug solution from the infusion container and become an independent, self-inflated liquid reservoir after being closed. 1
GB18458.2--2003
-Bottle piercer protective cover;
Bottle piercer;
Open/close clamp;
4--Hose;
Injection seat";
Air inlet with air filter and plug; Burette with scale;
Shut-off valve;
Breaker,
Drug solution filter;||t t||Hose;
Flow regulator;
Injection seat;
Conical cone head;
Conical cone head protection cover.
Figure 1 Typical burette infusion set example
Injection seat is not mandatory.
b Shutter of air inlet is not mandatory. The liquid filter can also be selected in other positions, for example, preferably close to the patient end. Usually the nominal pore size of the liquid filter is 15 μm. 2
Nominal capacity of burette/mL
6.3 Capacity of burette
Table 1 Volume and scale interval of burette
Scale interval (division value)/mL
The nominal capacity of the burette shall be marked according to the total capacity of the scale. 6.4 Scale
6.4.1 The scale lines of the burette shall be divided according to the intervals specified in Table 1. Number scale interval/mL
GB 18458.2—2003
Capacity tolerance of any
scale exceeding half of the nominal capacity/(%)
6.4.2 The scale lines should be clear, easily identifiable, durable, uniform in thickness, uniform in line spacing, and located in a plane perpendicular to the axis of the burette. 6.4.3 The length of the scale lines should be as shown in Figure 2. 6.4.4 The scale lines should be numbered as shown in Figure 2. The scale values ​​should be clear, durable, easily identifiable, and should be close to the end of the corresponding scale line but not touching the scale line.
6.4.5 If there is a shut-off valve in the burette, the position of the zero mark should be able to compensate for the volume occupied by the shut-off valve, the outlet at the bottom of the burette or other bottom cover parts that may affect the reading. The unit is millimeters
2. 5 min.
Nominal capacity: 50mL
Note: There may be no vertical line.
6.5 Particle content
150 mL
Figure 2 Scale for a typical burette infusion set
2. 5 min.
When tested according to Appendix F of GB8368--1998, the particle content of the infusion set shall not exceed the requirements of Table 2. —200
200 mL
GB 18458.2—2003
Note: It can also be tested with a light-blocking counter that meets the requirements. 2 Particle content of infusion sets
Nominal capacity of burette/mL
Chemical requirements
Chemical requirements shall comply with GB8368.
15 μm～25 μm/(piece/mL)
Note: When preparing the test solution according to GB8368, the burette part should be kept upright, otherwise it may not be able to circulate. 9
Biological requirements
Biological requirements shall comply with GB8368.
9 Marking
Label requirements shall comply with GB8368.
Packaging requirements shall comply with GB8368.
>25 μm/(pieces/mL)
Appendix A
(Informative Appendix)
Technical differences between this part and ISO/DIS8536-5:2000 and their causes Table A.1 gives a list of technical differences between this part and ISO/DIS8536-5:2000 and their causes. Table A.1 Technical differences between this part and ISO/DIS8536-5:2000 and their causes Article number of this part
6.4.5 Figure 2
Technical differences
The first paragraph adds the specification of nominal capacity of 200mL.
Delete the third paragraph in the scope.
Quote the Chinese standard that adopts the international standard. The three words "infusion set" are added to the mark. Change \6.2 to 6.4\ in the text to \6.2 to 6.5". A scale diagram of the specification of 200 mL is added to Figure 2. The requirements for particulate contamination are added.
Added a note.
GB18458.2—2003
Make this specification of infusion sets also included in the scope of this standard.
This paragraph is described from an international perspective, which is not suitable for my country.
To suit my country's national conditions.
The basic name of the product should be included in the label.
Chapter 6 adds 6.5.
This specification is added to the scope.
The structure of the burette infusion set is more complicated than that of the infusion set specified in GB8368. Therefore, this standard proposes this requirement based on the product structure characteristics of the burette infusion set to ensure the safe use of the infusion set.
Verification shows that it is necessary to add this note.
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