Foreword
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.
GB 8369 Transfusion sets for single use consists of the following parts:
——Part 1: Gravity feed;
——Part 2: With pressure infusion apparatus use;
...
This is Part 2 of GB 8369.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part has been redrafted and modified adoption of ISO 1135-5: 2015 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus.
This part includes technical changes with respect to ISO 1135-5:2015. The clause and subclause concerned are identified by a vertical single line (|) located in the blank on its external margin of the page. These technical changes and reasons are listed in Annex F.
The following editorial changes have also been made in this part:
——the standard name has been modified to "Transfusion sets for single use — Part 2: With pressure infusion apparatus use";
——the informative Annex E has been added, which provides guidelines for the design and implementation of blood transfusion sets in China;
——the informative Annex F has been added, in which the technical changes and reasons are listed with respect to ISO 1135-5:2015.
Attention is drawn to the possibility that some of the elements of this standard 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 part was proposed by and is under the jurisdiction of the National Medical Products Administration of the People’s Republic of China.
Transfusion sets for single use — Part 2: With pressure infusion apparatus use
1 Scope
This part of GB 8369 specifies requirements of material, physical, chemical and biological for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar).
This part is applicable to single use blood transfusions sets for pressure transfusion equipment, which are used in conjunction with containers for blood and blood components and intravenous injection equipment.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendments) applies.
GB/T 6682-2008 Water for analytical laboratory use — Specification and test methods (ISO 3696:1987, MOD)
GB 8369.1 Transfusion sets for single use — Part 1: Gravity feed (GB 8369.1-2019, ISO 1135-4:2015, MOD)
GB 14232.1-2020 Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers (ISO 3826-1:2013, MOD)
GB/T 14232.2 Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (GB/T 14232.2-2015.ISO 3826-2:2008, IDT)
GB/ T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use — Part 1: Chemical analysis methods
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use
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, ISO 15223-1:2012, IDT)
YY/T 1288 Nylon blood filter nets for transfusion equipments for single use
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
Note: For the purposes of Annex D, the following terms and definitions apply.
3.1
filling volume
VF
volume of tube during “pressure less” filling, respectively filling by gravity
Note 1: The tube remains unstressed.
Note 2: The filling volume is to be equated with the calculated volume of the tube.
3.2
storage volume
VS
tube volume during pressurization equal to filling volume, VF, plus bolus volume
VS=VF+VB
3.3
bolus volume
VB
increased tube volume during pressurization (VS) in comparison with the unstressed tube (VF)
Note: For illustration of the bolus volume, see Figure 1.
Keys:
1——patient;
2——occlusion;
3——tube;
4——bolus volume;
5——syringe pump.
Figure 1 Bolus volume
4 General requirements
4.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 2.
Keys:
1——protective cap of the closure-piercing device;
2——closure-piercing device;
3——fluid channel;
4——drip tube;
5——drip chamber;
6——filter for blood and blood components;
7——tubing;
8——flow regulator;
9——injection site;
10——male conical fitting;
11——protective cap of the male conical fitting.
a Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable, if the same safety aspects are ensured.
b Injection site is optional.
Figure 2 Example of a transfusion set
4.2 Maintenance of sterility
The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Nomenclature for components of the transfusion set
4.2 Maintenance of sterility
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Leakage
6.3 Tensile strength
6.4 Closure-piercing device
6.5 Tubing
6.6 Filter for blood and blood components.
6.7 Drip chamber and drip tube
6.8 Flow regulator
6.9 Flow rate of blood and blood components
6.10 Injection site
6.11 Male conical fitting
6.12 Protective caps
6.13 Storage volume
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
8.6 Assessment of blood component residue
8.7 Assessment of damage to blood components
9 Labelling
9.1 General
9.2 Unit container
9.3 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 (Normative) Storage volume
Annex E (Informative) Design and implementation guide
Annex F (Informative) Technical differences and reasons between this part and ISO 1135-5:
Bibliography
Foreword
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.
GB 8369 Transfusion sets for single use consists of the following parts:
——Part 1: Gravity feed;
——Part 2: With pressure infusion apparatus use;
...
This is Part 2 of GB 8369.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part has been redrafted and modified adoption of ISO 1135-5: 2015 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus.
This part includes technical changes with respect to ISO 1135-5:2015. The clause and subclause concerned are identified by a vertical single line (|) located in the blank on its external margin of the page. These technical changes and reasons are listed in Annex F.
The following editorial changes have also been made in this part:
——the standard name has been modified to "Transfusion sets for single use — Part 2: With pressure infusion apparatus use";
——the informative Annex E has been added, which provides guidelines for the design and implementation of blood transfusion sets in China;
——the informative Annex F has been added, in which the technical changes and reasons are listed with respect to ISO 1135-5:2015.
Attention is drawn to the possibility that some of the elements of this standard 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 part was proposed by and is under the jurisdiction of the National Medical Products Administration of the People’s Republic of China.
Transfusion sets for single use — Part 2: With pressure infusion apparatus use
1 Scope
This part of GB 8369 specifies requirements of material, physical, chemical and biological for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar).
This part is applicable to single use blood transfusions sets for pressure transfusion equipment, which are used in conjunction with containers for blood and blood components and intravenous injection equipment.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendments) applies.
GB/T 6682-2008 Water for analytical laboratory use — Specification and test methods (ISO 3696:1987, MOD)
GB 8369.1 Transfusion sets for single use — Part 1: Gravity feed (GB 8369.1-2019, ISO 1135-4:2015, MOD)
GB 14232.1-2020 Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers (ISO 3826-1:2013, MOD)
GB/T 14232.2 Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (GB/T 14232.2-2015.ISO 3826-2:2008, IDT)
GB/ T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use — Part 1: Chemical analysis methods
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use
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, ISO 15223-1:2012, IDT)
YY/T 1288 Nylon blood filter nets for transfusion equipments for single use
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
Note: For the purposes of Annex D, the following terms and definitions apply.
3.1
filling volume
VF
volume of tube during “pressure less” filling, respectively filling by gravity
Note 1: The tube remains unstressed.
Note 2: The filling volume is to be equated with the calculated volume of the tube.
3.2
storage volume
VS
tube volume during pressurization equal to filling volume, VF, plus bolus volume
VS=VF+VB
3.3
bolus volume
VB
increased tube volume during pressurization (VS) in comparison with the unstressed tube (VF)
Note: For illustration of the bolus volume, see Figure 1.
Keys:
1——patient;
2——occlusion;
3——tube;
4——bolus volume;
5——syringe pump.
Figure 1 Bolus volume
4 General requirements
4.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 2.
Keys:
1——protective cap of the closure-piercing device;
2——closure-piercing device;
3——fluid channel;
4——drip tube;
5——drip chamber;
6——filter for blood and blood components;
7——tubing;
8——flow regulator;
9——injection site;
10——male conical fitting;
11——protective cap of the male conical fitting.
a Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable, if the same safety aspects are ensured.
b Injection site is optional.
Figure 2 Example of a transfusion set
4.2 Maintenance of sterility
The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used.
Contents of GB 8369.2-2020
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Nomenclature for components of the transfusion set
4.2 Maintenance of sterility
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Leakage
6.3 Tensile strength
6.4 Closure-piercing device
6.5 Tubing
6.6 Filter for blood and blood components.
6.7 Drip chamber and drip tube
6.8 Flow regulator
6.9 Flow rate of blood and blood components
6.10 Injection site
6.11 Male conical fitting
6.12 Protective caps
6.13 Storage volume
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
8.6 Assessment of blood component residue
8.7 Assessment of damage to blood components
9 Labelling
9.1 General
9.2 Unit container
9.3 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 (Normative) Storage volume
Annex E (Informative) Design and implementation guide
Annex F (Informative) Technical differences and reasons between this part and ISO 1135-5:
Bibliography
