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.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is modified in relation to ISO 18242: 2016 Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps.
Technical changes have been made in this standard with respect to ISO 18242: 2016, and marked with perpendicular single line (|) at the margin of relevant clauses; see Annex A for the list of relevant technical differences and their causes.
In addition, the following editorial changes have been made in this standard:
——The standard name is modified.
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 standard shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of National Technical Committee on Medical Extracorporeal Circulation Equipment Standardization Administration of China (SAC/TC 158).
Introduction
This standard is intended to ensure that centrifugal pump-heads designed to provide continuous flow of blood in support of, or as a substitution for, the normal pumping function of the heart have been adequately tested for both their safety and function, and that product characteristics are appropriately disclosed when labelling the device.
This standard therefore contains procedures to be used for evaluation of extracorporeal centrifugal pump-head. Test procedures for determination of the hydraulic performance, blood cell damage and other performance are described, although limits for these characteristics are not specified. Ready identification of the characteristics shall, however, assist the user in the selection of a product that will suit the needs of the patient.
This standard also includes minimum reporting requirements, which will allow the user to compare service performance of centrifugal pump-heads of different designs in a standard way.
Requirements for animal and clinical studies have not been included in this standard. Such studies may be part of a manufacturer’s quality system.
This standard contains only those requirements that are specific to centrifugal pump-heads. Non-specific requirements are covered by references to other standards listed in Clause 2.
Cardiopulmonary bypass systems—
Centrifugal pump-head
1 Scope
This standard specifies requirements for sterile, single-use, extracorporeal centrifugal pump-heads, whether coated, surface-modified, or non-surface modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, and extracorporeal membrane oxygenation.
This standard does not apply to centrifugal pumps used as ventricular assist devices, and other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
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 14233.1-2008 Test methods for infusion, transfusion, injection equipment for medical use—Part 1: chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices–Part 1: Evaluation and testing within a risk management process (ISO 10993-1: 2009, IDT)
GB 18279.1 Sterilization of health-care products—Ethylene oxide—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18279.1-2015, ISO 11135-1: 2007, IDT)
GB 18280.1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1—2015, ISO 11137-1: 2006, IDT)
GB 19335-2003 Blood flow products for single use—General specification
GB/T 19633.1 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1: 2006, IDT)
GB/T 19633.2 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes (GB/T 19633.2-2015, ISO 11607-2: 2006, IDT)
GB/T 19974 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices (GB/T 19974-2018, ISO 14937: 2009, IDT)
YY/T 0681.1 Test methods for sterile medical device package—Part 1: Test guide for accelerated aging
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
centrifugal pump-head
extracorporeal device designed to produce rotational flow by means of radial force
3.2
blood pathway
paths of the pump containing blood during intended clinical use
3.3
operating variables
settings of controls that affect the function of the device
3.4
blood cell damage
loss or destruction of cellular components of the blood
3.5
platelet reduction
percentage reduction of platelets contained in a circuit incorporating a centrifugal pump as a function of time
3.6
plasma-free hemoglobin level
concentration of plasma-free hemoglobin in a circuit incorporating a centrifugal pump, as a function of time
3.7
normalized index of hemolysis; NIH
grams of plasma-free hemoglobin released after pumping 100L of blood
3.8
white blood cell reduction
percentage reduction of white blood cells contained in a circuit incorporating a centrifugal pump as a function of time
3.9
blood analogue
test liquid which simulates blood viscosity between 2.0 × 10–3 Pa·S to 3.5 × 10–3 Pa·S or defined by the manufacturer based on appropriate haematocrit and temperature of the circulating blood during intended clinical use (i.e. hypothermic conditions)
3.10
predicate pump-head
similar pump to the test pump that has previously been approved and used for the same intended clinical use
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
The blood pathway shall be sterile and non-pyrogenic.
Note: Bacterial endotoxin limits are specified by the manufacturer.
4.1.2 Biocompatibility
All parts of the blood pathway shall be biocompatible with respect to their intended use.
4.1.3 Residual quantity of ethylene oxide
If the ethylene oxide is used for sterilization, disinfected with ethylene oxide, its residual quantity shall not be greater than 10 μg/g.
4.2 Physical characteristics
4.2.1 Blood pathway integrity
The blood pathway shall not leak.
4.2.2 Prime volume
The volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3).
4.2.3 Connector integrity
The inlet and outlet ports shall allow a secure connection.
Note: Connectors of a type that allow connection of tubes with an inner diameter of 4.8 mm, 6.3 mm, 9.5 mm, or 12.7 mm, or a type that complies with YY 0604.
4.2.4 Particulate content
The number of particles from 15 μm to 25 μm per square centimeter of internal surface area shall not exceed 1; and that of particles larger than 25 μm shall not exceed 0.5.
4.2.5 Coatings
If applicable, the coating performance shall conform to the manufacturer's requirements.
4.2.6 Temperature adaptability
It shall not be deformed and fractured in the range of 0°C to 50°C.
4.3 Service performance
4.3.1 Hydraulic performance
The flow rates, pressure, and revolutions per minute (r/min) shall be within the range of values specified by the manufacturer.
4.3.2 Blood cell damage
4.3.2.1 General
The test shall be carried out according to 5.4.2 under the maximum flow specified by the manufacturer at a certain temperature with appropriate circuit blood volume, back pressure and pump speed.
4.3.2.2 Plasma-free hemoglobin
The rate of generation of plasma-free hemoglobin shall be within the range of values specified by the manufacturer.
The hemolysis results shall be reported as NIH, in g/100L or mg/dL.
See Equation (1) for NIH calculation:
"NIH"=ΔfHb×V×(100-Hct)/100×100/(Q×T) (1)
where,
NIH——the normalized index of hemolysis, g/100 L;
ΔfHb——the increase of plasma-free hemoglobin concentration over the sampling time interval, g/L;
V——the circuit volume, L;
Q——the flow rate, L/min;
Hct——the hematocrit,%;
T——the sampling time interval, min.
4.3.2.3 Platelet reduction
The platelet reduction shall be within the range of values specified by the manufacturer.
4.3.2.4 White blood cell reduction
The white blood cell reduction shall be within the range of values specified by the manufacturer.
4.3.3 Bearing durability
The bearing shall remain functional over the duration of the testing specified by the manufacturer, if applicable.
Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test methods 6 Information supplied by the manufacturer 7 Packaging Annex A (Informative) Technical differences between this standard and ISO 18242: 2016 and their causes Bibliography
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.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is modified in relation to ISO 18242: 2016 Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps.
Technical changes have been made in this standard with respect to ISO 18242: 2016, and marked with perpendicular single line (|) at the margin of relevant clauses; see Annex A for the list of relevant technical differences and their causes.
In addition, the following editorial changes have been made in this standard:
——The standard name is modified.
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 standard shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of National Technical Committee on Medical Extracorporeal Circulation Equipment Standardization Administration of China (SAC/TC 158).
Introduction
This standard is intended to ensure that centrifugal pump-heads designed to provide continuous flow of blood in support of, or as a substitution for, the normal pumping function of the heart have been adequately tested for both their safety and function, and that product characteristics are appropriately disclosed when labelling the device.
This standard therefore contains procedures to be used for evaluation of extracorporeal centrifugal pump-head. Test procedures for determination of the hydraulic performance, blood cell damage and other performance are described, although limits for these characteristics are not specified. Ready identification of the characteristics shall, however, assist the user in the selection of a product that will suit the needs of the patient.
This standard also includes minimum reporting requirements, which will allow the user to compare service performance of centrifugal pump-heads of different designs in a standard way.
Requirements for animal and clinical studies have not been included in this standard. Such studies may be part of a manufacturer’s quality system.
This standard contains only those requirements that are specific to centrifugal pump-heads. Non-specific requirements are covered by references to other standards listed in Clause 2.
Cardiopulmonary bypass systems—
Centrifugal pump-head
1 Scope
This standard specifies requirements for sterile, single-use, extracorporeal centrifugal pump-heads, whether coated, surface-modified, or non-surface modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, and extracorporeal membrane oxygenation.
This standard does not apply to centrifugal pumps used as ventricular assist devices, and other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
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 14233.1-2008 Test methods for infusion, transfusion, injection equipment for medical use—Part 1: chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices–Part 1: Evaluation and testing within a risk management process (ISO 10993-1: 2009, IDT)
GB 18279.1 Sterilization of health-care products—Ethylene oxide—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18279.1-2015, ISO 11135-1: 2007, IDT)
GB 18280.1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1—2015, ISO 11137-1: 2006, IDT)
GB 19335-2003 Blood flow products for single use—General specification
GB/T 19633.1 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1: 2006, IDT)
GB/T 19633.2 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes (GB/T 19633.2-2015, ISO 11607-2: 2006, IDT)
GB/T 19974 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices (GB/T 19974-2018, ISO 14937: 2009, IDT)
YY/T 0681.1 Test methods for sterile medical device package—Part 1: Test guide for accelerated aging
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
centrifugal pump-head
extracorporeal device designed to produce rotational flow by means of radial force
3.2
blood pathway
paths of the pump containing blood during intended clinical use
3.3
operating variables
settings of controls that affect the function of the device
3.4
blood cell damage
loss or destruction of cellular components of the blood
3.5
platelet reduction
percentage reduction of platelets contained in a circuit incorporating a centrifugal pump as a function of time
3.6
plasma-free hemoglobin level
concentration of plasma-free hemoglobin in a circuit incorporating a centrifugal pump, as a function of time
3.7
normalized index of hemolysis; NIH
grams of plasma-free hemoglobin released after pumping 100L of blood
3.8
white blood cell reduction
percentage reduction of white blood cells contained in a circuit incorporating a centrifugal pump as a function of time
3.9
blood analogue
test liquid which simulates blood viscosity between 2.0 × 10–3 Pa·S to 3.5 × 10–3 Pa·S or defined by the manufacturer based on appropriate haematocrit and temperature of the circulating blood during intended clinical use (i.e. hypothermic conditions)
3.10
predicate pump-head
similar pump to the test pump that has previously been approved and used for the same intended clinical use
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
The blood pathway shall be sterile and non-pyrogenic.
Note: Bacterial endotoxin limits are specified by the manufacturer.
4.1.2 Biocompatibility
All parts of the blood pathway shall be biocompatible with respect to their intended use.
4.1.3 Residual quantity of ethylene oxide
If the ethylene oxide is used for sterilization, disinfected with ethylene oxide, its residual quantity shall not be greater than 10 μg/g.
4.2 Physical characteristics
4.2.1 Blood pathway integrity
The blood pathway shall not leak.
4.2.2 Prime volume
The volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3).
4.2.3 Connector integrity
The inlet and outlet ports shall allow a secure connection.
Note: Connectors of a type that allow connection of tubes with an inner diameter of 4.8 mm, 6.3 mm, 9.5 mm, or 12.7 mm, or a type that complies with YY 0604.
4.2.4 Particulate content
The number of particles from 15 μm to 25 μm per square centimeter of internal surface area shall not exceed 1; and that of particles larger than 25 μm shall not exceed 0.5.
4.2.5 Coatings
If applicable, the coating performance shall conform to the manufacturer's requirements.
4.2.6 Temperature adaptability
It shall not be deformed and fractured in the range of 0°C to 50°C.
4.3 Service performance
4.3.1 Hydraulic performance
The flow rates, pressure, and revolutions per minute (r/min) shall be within the range of values specified by the manufacturer.
4.3.2 Blood cell damage
4.3.2.1 General
The test shall be carried out according to 5.4.2 under the maximum flow specified by the manufacturer at a certain temperature with appropriate circuit blood volume, back pressure and pump speed.
4.3.2.2 Plasma-free hemoglobin
The rate of generation of plasma-free hemoglobin shall be within the range of values specified by the manufacturer.
The hemolysis results shall be reported as NIH, in g/100L or mg/dL.
See Equation (1) for NIH calculation:
"NIH"=ΔfHb×V×(100-Hct)/100×100/(Q×T) (1)
where,
NIH——the normalized index of hemolysis, g/100 L;
ΔfHb——the increase of plasma-free hemoglobin concentration over the sampling time interval, g/L;
V——the circuit volume, L;
Q——the flow rate, L/min;
Hct——the hematocrit,%;
T——the sampling time interval, min.
4.3.2.3 Platelet reduction
The platelet reduction shall be within the range of values specified by the manufacturer.
4.3.2.4 White blood cell reduction
The white blood cell reduction shall be within the range of values specified by the manufacturer.
4.3.3 Bearing durability
The bearing shall remain functional over the duration of the testing specified by the manufacturer, if applicable.
Contents of YY/T 1739-2020
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Information supplied by the manufacturer
7 Packaging
Annex A (Informative) Technical differences between this standard and ISO 18242: 2016 and their causes
Bibliography
