Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All technical contents of this standard are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 8368-2005 Infusion sets for single use, Gravity feed. In addition to editorial changes, the following main technical changes have been made with respect to GB 8368-2005:
——the notes in the tubing are changed to the text (see 6.6; 6.6 in Edition 2005);
——the restriction on the color of flow regulator is deleted (6.9 in Edition 2005);
——the position requirements of injection sites are changed to compulsory requirements, and a note is added (see 6.11; 6.11 in Edition 2005);
——the requirement of outer cone joint is changed to compulsory requirement (see 6.12; 6.12 in Edition 2005);
——the requirements for reducing substances and the representation of test methods are modified (see 7.1 and B.2; 7.1 and B.2 in Edition 2005);
——the requirement that the symbol 2725 of ISO 7000 may be used to indicate the existence of a certain substance of concern is added (see notes in 9.1 and 9.2);
——the requirements for packaging are added (see 10.3);
——the requirements for disposal are added (see Chapter 11);
——the particulate pollution index and its test method are modified (see A.1; A.1 in Edition 2005);
——the leakage test is modified (see A.2; A.2 in Edition 2005);
The standard has been redrafted and modified in relation to ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
Technical differences between this standard and ISO 8536-4: 2010 are marked with perpendicular single line (|) in the outside page margin of the provisions concerned. These technical changes and reasons are listed in Annex E.
The amendments of ISO 8536-4:2010/Amd.1: 2013 have been included in this standard, which are marked with a perpendicular double line (||)in the outside page margin of the provisions concerned.
In addition, the following editorial changes have been made:
——Annex D (informative) is added to provide the design and implementation guidelines for infusion sets in China.
——Annex E (informative) is added to list the technical differences and their causes compared with ISO 8536-4:2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by and is under the jurisdiction of China State Food and Drug Administration.
The previous editions of this standard are as follows:
This standard specifies the marking, material, physical, chemical and biological requirements of gravity feed infusion set for single use.
This standard specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696:1987, MOD)
GB/T 14233.1-2008 Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 15811 Sterile hypodermic needles for single use (GB 15811-2016, ISO 7864:1993, NEQ)
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1, 2009, IDT)
GB/T 25915.1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (GB/T 25915.1-2010, ISO 14644-1:1999, 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, 1SO 15223-1:2012, IDT) 2012, 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 are used for collapsible plastic 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, are used for rigid containers.
3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.
Keys:
1——protective cap of closure-piercing device;
2——closure-piercing device;
3——air inlet with air filter and closure;
4——fluid channel;
5——drip tube;
6——drip chamber;
7——fluid filter;
8——tubing;
9——flow regulator;
10——injection site;
11——male conical fitting;
12——protective cap of male conical fitting.
a Closure of the air inlet is optional.
b The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal pore size of 15 µm.
c The injection site is optional.
Figure 1 Example of a vented infusion set
Keys:
1——protective cap of closure-piercing device;
2——closure-piercing device;
3——fluid channel;
4——drip tube;
5——drip chamber;
6——fluid filter;
7——tubing;
8——flow regulator;
9——injection site;
10——male conical fitting;
11——protective cap of the male conical fitting.
a The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal pore size of 15 µm.
b The injection site is optional.
Figure 2 Example of a non-vented infusion set
Keys:
1——protective cap;
2——closure-piercing device or needle;
3——tubing;
4——clamp;
5——air-inlet with air filter.
a Other designs are acceptable if the same safety aspects are ensured.
Figure 3 Example of an air-inlet device
4 Designation
4.1 Infusion set
Infusion sets complying with the requirements specified in this standard shall be designated by the descriptor words, followed by the letters IS, followed by the letter G:
Infusion set GB 8536- IS – G
4.2 Air-inlet device
Air-inlet devices complying with the requirements specified in this standard shall be designated by the descriptor words, followed by the letters IS, followed by the letters AD:
Air-inlet device GB 8536- IS – AD
5 Materials
The materials from which the infusion set and its components are manufactured (as described in Clause 3) shall comply with the requirements specified in Clause 6. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8.
6 Physical requirements
6.1 Particulate contamination
The infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of particles shall not exceed the contamination index limit.
6.2 Leakage
The infusion set, when tested in accordance with A.2, shall show no signs of air leakage.
6.3 Tensile strength
When tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.
6.4 Closure-piercing device
The dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4.
Note: The dimension of 15 mm in Figure 4 is a reference measurement. The cross-section of the piercing device at this site is a circle.
The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.
Foreword i 1 Scope 2 Normative references 3 General requirements 4 Designation 4.1 Infusion set 4.2 Air-inlet device 5 Materials 6 Physical requirements 6.1 Particulate contamination 6.2 Leakage 6.3 Tensile strength 6.4 Closure-piercing device 6.5 Air-inlet device 6.6 Tubing 6.7 Fluid filter 6.8 Drip chamber and drip tube 6.9 Flow regulator 6.10 Flow rate of infusion fluid 6.11 Injection site 6.12 Male conical fitting 6.13 Protective caps 7 Chemical requirements 7.1 Reducing (oxidizable) matter 7.2 Metal ions 7.3 Titration acidity or alkalinity 7.4 Residue on evaporation 7.5 UV absorption of extract solution 7.6 Residual quantity of ethylene oxide 8 Biological requirements 8.1 General 8.2 Sterility 8.3 Pyrogenicity 8.4 Haemolysis 8.5 Toxicity 9 Labelling 9.1 Unit container 9.2 Shelf or multi-unit container 10 Packaging 11 Disposal Annex A (Normative) Physical tests Annex B (Normative) Chemical tests Annex C (Normative) Biological tests Annex D (Informative) Design and implementation guidelines Annex E (Informative) Technical differences between this standard and ISO 8536-4: 2010 and their reasons Bibliography Figure 1 Example of a vented infusion set Figure 2 Example of a non-vented infusion set Figure 3 Example of an air-inlet device Figure 4 Dimensions of the closure-piercing device Figure A.1 Apparatus for testing the efficiency of the fluid filter Table A.1 Evaluation of contamination by particles Table E.1 Technical differences between this standard and ISO 8536-4: 2010 and their reasons
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All technical contents of this standard are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 8368-2005 Infusion sets for single use, Gravity feed. In addition to editorial changes, the following main technical changes have been made with respect to GB 8368-2005:
——the notes in the tubing are changed to the text (see 6.6; 6.6 in Edition 2005);
——the restriction on the color of flow regulator is deleted (6.9 in Edition 2005);
——the position requirements of injection sites are changed to compulsory requirements, and a note is added (see 6.11; 6.11 in Edition 2005);
——the requirement of outer cone joint is changed to compulsory requirement (see 6.12; 6.12 in Edition 2005);
——the requirements for reducing substances and the representation of test methods are modified (see 7.1 and B.2; 7.1 and B.2 in Edition 2005);
——the requirement that the symbol 2725 of ISO 7000 may be used to indicate the existence of a certain substance of concern is added (see notes in 9.1 and 9.2);
——the requirements for packaging are added (see 10.3);
——the requirements for disposal are added (see Chapter 11);
——the particulate pollution index and its test method are modified (see A.1; A.1 in Edition 2005);
——the leakage test is modified (see A.2; A.2 in Edition 2005);
The standard has been redrafted and modified in relation to ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
Technical differences between this standard and ISO 8536-4: 2010 are marked with perpendicular single line (|) in the outside page margin of the provisions concerned. These technical changes and reasons are listed in Annex E.
The amendments of ISO 8536-4:2010/Amd.1: 2013 have been included in this standard, which are marked with a perpendicular double line (||)in the outside page margin of the provisions concerned.
In addition, the following editorial changes have been made:
——Annex D (informative) is added to provide the design and implementation guidelines for infusion sets in China.
——Annex E (informative) is added to list the technical differences and their causes compared with ISO 8536-4:2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by and is under the jurisdiction of China State Food and Drug Administration.
The previous editions of this standard are as follows:
—— GB 8368-1987, GB 8368-1993, GB 8368-1998, GB 8368-2005.
Infusion sets for single use - Gravity feed
1 Scope
This standard specifies the marking, material, physical, chemical and biological requirements of gravity feed infusion set for single use.
This standard specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696:1987, MOD)
GB/T 14233.1-2008 Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 15811 Sterile hypodermic needles for single use (GB 15811-2016, ISO 7864:1993, NEQ)
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1, 2009, IDT)
GB/T 25915.1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (GB/T 25915.1-2010, ISO 14644-1:1999, 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, 1SO 15223-1:2012, IDT) 2012, 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 are used for collapsible plastic 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, are used for rigid containers.
3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.
Keys:
1——protective cap of closure-piercing device;
2——closure-piercing device;
3——air inlet with air filter and closure;
4——fluid channel;
5——drip tube;
6——drip chamber;
7——fluid filter;
8——tubing;
9——flow regulator;
10——injection site;
11——male conical fitting;
12——protective cap of male conical fitting.
a Closure of the air inlet is optional.
b The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal pore size of 15 µm.
c The injection site is optional.
Figure 1 Example of a vented infusion set
Keys:
1——protective cap of closure-piercing device;
2——closure-piercing device;
3——fluid channel;
4——drip tube;
5——drip chamber;
6——fluid filter;
7——tubing;
8——flow regulator;
9——injection site;
10——male conical fitting;
11——protective cap of the male conical fitting.
a The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal pore size of 15 µm.
b The injection site is optional.
Figure 2 Example of a non-vented infusion set
Keys:
1——protective cap;
2——closure-piercing device or needle;
3——tubing;
4——clamp;
5——air-inlet with air filter.
a Other designs are acceptable if the same safety aspects are ensured.
Figure 3 Example of an air-inlet device
4 Designation
4.1 Infusion set
Infusion sets complying with the requirements specified in this standard shall be designated by the descriptor words, followed by the letters IS, followed by the letter G:
Infusion set GB 8536- IS – G
4.2 Air-inlet device
Air-inlet devices complying with the requirements specified in this standard shall be designated by the descriptor words, followed by the letters IS, followed by the letters AD:
Air-inlet device GB 8536- IS – AD
5 Materials
The materials from which the infusion set and its components are manufactured (as described in Clause 3) shall comply with the requirements specified in Clause 6. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8.
6 Physical requirements
6.1 Particulate contamination
The infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of particles shall not exceed the contamination index limit.
6.2 Leakage
The infusion set, when tested in accordance with A.2, shall show no signs of air leakage.
6.3 Tensile strength
When tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.
6.4 Closure-piercing device
The dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4.
Note: The dimension of 15 mm in Figure 4 is a reference measurement. The cross-section of the piercing device at this site is a circle.
The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.
Contents of GB 8368-2018
Foreword i
1 Scope
2 Normative references
3 General requirements
4 Designation
4.1 Infusion set
4.2 Air-inlet device
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Leakage
6.3 Tensile strength
6.4 Closure-piercing device
6.5 Air-inlet device
6.6 Tubing
6.7 Fluid filter
6.8 Drip chamber and drip tube
6.9 Flow regulator
6.10 Flow rate of infusion fluid
6.11 Injection site
6.12 Male conical fitting
6.13 Protective caps
7 Chemical requirements
7.1 Reducing (oxidizable) matter
7.2 Metal ions
7.3 Titration acidity or alkalinity
7.4 Residue on evaporation
7.5 UV absorption of extract solution
7.6 Residual quantity of ethylene oxide
8 Biological requirements
8.1 General
8.2 Sterility
8.3 Pyrogenicity
8.4 Haemolysis
8.5 Toxicity
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
10 Packaging
11 Disposal
Annex A (Normative) Physical tests
Annex B (Normative) Chemical tests
Annex C (Normative) Biological tests
Annex D (Informative) Design and implementation guidelines
Annex E (Informative) Technical differences between this standard and ISO 8536-4: 2010 and their reasons
Bibliography
Figure 1 Example of a vented infusion set
Figure 2 Example of a non-vented infusion set
Figure 3 Example of an air-inlet device
Figure 4 Dimensions of the closure-piercing device
Figure A.1 Apparatus for testing the efficiency of the fluid filter
Table A.1 Evaluation of contamination by particles
Table E.1 Technical differences between this standard and ISO 8536-4: 2010 and their reasons
