ASTM F1830-19

Standard Practice for Collection and Preparation of Blood for Dynamic <emph type="bdit" >in vitro</emph> Evaluation of Hemolysis in Blood Pumps

SIGNIFICANCE AND USE
5.1 In vitro hemolysis test results for blood pumps may be substantially affected by donor species, sex, age, fasting, the method of harvesting, the anticoagulant properties, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood.3,4 Therefore, standardization of proper whole blood collection and preparation for the dynamic in vitro evaluation of blood pumps is essential, and this recommended practice will allow an acceptable comparison of test results among hemolysis tests involving similar testing methods.
SCOPE
1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use.  
1.2 This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro evaluation (see Practice F1841) of the following devices:  
1.2.1 Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.).  
1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.).  
1.3 The source and preparation of whole blood utilized for the dynamic in vitro evaluation of red blood cell (erythrocyte) trauma caused by blood pumps can substantially influence the hemolysis performance of these devices. Thus, standardized whole blood collection and preparation methods are required.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Aug-2019
• ICS: 11.100 - Laboratory medicine
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.30 - Cardiovascular Standards

Relations

• Replaces: ASTM F1830-97(2017) - Standard Practice for Selection of Blood for <emph type="bdit">in vitro</emph> Evaluation of Blood Pumps
• Effective Date: 01-Sep-2019
• Refers: ASTM F1841-97(2017) - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• Effective Date: 01-Sep-2017
• Refers: ASTM F1841-97(2013) - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• Effective Date: 01-Mar-2013
• Refers: ASTM F1841-97(2005) - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• Effective Date: 01-Mar-2005
• Refers: ASTM F1841-97 - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• Effective Date: 01-Jan-1997
• Referred By: ASTM F1841-19e1 - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• Effective Date: 01-Sep-2019

Overview

ASTM F1830-19 is the internationally recognized standard practice for the collection and preparation of whole blood used in the dynamic in vitro evaluation of hemolysis in blood pumps. Developed by ASTM International, this standard is essential for the standardized assessment of blood pump devices designed for clinical applications. It outlines the proper protocols for blood collection, handling, storage, and preparation to ensure reliable and comparable hemolysis testing results. These guidelines help reduce variability caused by differences in blood source and preparation, enabling more accurate measurement of red blood cell (erythrocyte) trauma induced by blood pumps.

Key Topics

• Blood Source and Donor Selection: Covers recommended donor species (human, bovine, porcine, ovine), health status, and collection practices to limit contamination and ensure blood quality.
• Collection Methods: Specifies venipuncture techniques, appropriate anticoagulant solutions (such as citrate, CPDA-1, heparin), and optimal temperature control during collection and storage.
• Preparation and Handling: Details steps to minimize mechanical trauma and hemolysis, including limits on negative pressure, exclusion of pooled blood from multiple donors, and avoidance of contamination with particulates or microthrombi.
• Storage Conditions: Blood should be refrigerated at 2-8°C and used within defined time frames (typically 24-48 hours) to preserve cell integrity and function.
• Testing Conditions: Blood should be warmed to physiological temperature (typically 37°C) prior to use in in vitro hemolysis testing, with close attention to removal of air bubbles and maintenance of physiological parameters.
• Quality Control: Only blood with acceptable hemoglobin and hematocrit levels, and minimal free plasma hemoglobin, should be used for hemolysis testing to ensure data reliability.

Applications

ASTM F1830-19 plays a crucial role in the medical device industry, particularly in the evaluation of:

• Blood Pumps: Applies to both continuous flow (centrifugal, axial, roller) and pulsatile/intermittent flow pumps (pneumatically or electromagnetically driven) intended for clinical use. Standardized protocols improve safety and effectiveness assessments for both existing and new blood pump designs.
• Preclinical Testing: By providing uniformity in blood sourcing and handling, the standard supports accurate in vitro testing of blood pumps, facilitating regulatory submissions and comparative device studies.
• Device Development and Quality Assurance: Manufacturers integrate ASTM F1830-19 into their R&D and quality assurance programs to minimize hemolysis and optimize pump performance.
• Academic and Clinical Research: Laboratories use these guidelines to ensure reproducibility and reliability of hemolysis data across studies and institutions.

Related Standards

• ASTM F1841: Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps, which guides actual hemolysis testing procedures linked to the blood preparation in F1830-19.
• ISO 7199: Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators), where blood handling protocols align closely with those in F1830-19.
• ISO 10993 Series: Biological evaluation of medical devices, addressing broader biocompatibility considerations including blood-contacting materials.

---

Keywords: blood pump hemolysis testing, in vitro blood evaluation, blood collection for medical device testing, blood preparation standards, ASTM F1830-19, medical device standardization, hemolysis performance, blood trauma assessment, continuous flow pump testing, pulsatile pump assessment.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1830 − 19
Standard Practice for
Collection and Preparation of Blood for Dynamic in vitro
Evaluation of Hemolysis in Blood Pumps
This standard is issued under the fixed designation F1830; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This practice covers whole blood that will be used for 3.1 Definitions of Terms Specific to This Standard:
the in vitro performance assessment of hemolysis in blood 3.1.1 blood pump—a device that replaces or supplements
pumps intended for clinical use. thefunctionofthehumanhearttocirculatebloodbyproducing
continuous or time-varying blood flow.
1.2 This practice covers the recommended standard
3.1.2 hemolysis—one of the parameters of blood damage
collection, preparation, handling, storage, and utilization of
caused by a blood pump, characterized by the liberation of
whole blood for the in vitro evaluation (see Practice F1841)of
hemoglobin from damaged erythrocytes into the plasma. He-
the following devices:
molysis can occur from mechanical, thermal, or chemical
1.2.1 Continuous flow blood pumps (roller pumps, centrifu-
sources in medical devices.
gal pumps, axial flow pumps, etc.).
1.2.2 Pulsatile and intermittent flow blood pumps (pneu-
4. Summary of Practice
matically driven, electro-mechanically driven, with an artificial
pulse, etc.).
4.1 For the experimental evaluation of hemolysis caused by
pump designs, materials, and operational conditions (see Prac-
1.3 The source and preparation of whole blood utilized for
ticeF1841),dynamic in vitrohemolysistestsarerecommended
the dynamic in vitro evaluation of red blood cell (erythrocyte)
using fresh animal or human blood. The blood donor should
trauma caused by blood pumps can substantially influence the
have an afebrile body temperature, no physical signs or
hemolysis performance of these devices. Thus, standardized
symptoms of disease, including diarrhea and/or rhinorrhea, and
whole blood collection and preparation methods are required.
an acceptable normal range of hematological parameters (e.g.
1.4 The values stated in SI units are to be regarded as
RBC, WBC, and platelet counts, hematocrit, total hemoglobin
standard. No other units of measurement are included in this
concentration). If animal blood is obtained from an abattoir, it
standard.
is preferable that it be collected by controlled venipuncture to
1.5 This international standard was developed in accor-
minimize the risk of contamination with debris or fluids other
dance with internationally recognized principles on standard-
than blood. While human blood would be the most relevant for
ization established in the Decision on Principles for the
performing preclinical device studies, the practicality of ob-
Development of International Standards, Guides and Recom-
taining sufficient quantities of cross-matched donor blood
mendations issued by the World Trade Organization Technical
needs to be considered.
Barriers to Trade (TBT) Committee.
5. Significance and Use
2. Referenced Documents
5.1 In vitro hemolysis test results for blood pumps may be
2.1 ASTM Standards:
substantially affected by donor species, sex, age, fasting, the
F1841 Practice for Assessment of Hemolysis in Continuous
method of harvesting, the anticoagulant properties, the period
Flow Blood Pumps
of storage, the biochemical state of the blood, and the hemo-
3,4
globin and hematocrit level of blood. Therefore, standard-
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
izationofproperwholebloodcollectionandpreparationforthe
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved Sept. 1, 2019. Published December 2019. Originally
approved in 1997. Last previous edition approved in 2017 as F1830 – 97 (2017). Mueller NM, et al. In Vitro Hematological Testing of Rotary Blood Pumps:
DOI: 10.1520/F1830-19. Remarks on Standardization and Data Interpretation. Artif Organs, 17 (2), 1993, pp.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 103–110.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Mizuguchi K, et al. Does Hematocrit Affect In Vitro Hemolysis Test Results?:
Standards volume information, refer to the standard’s Document Summary page on Preliminary Studies with NASAAxial Flow Pump. Artif Organs 18 (9), 1994, pp.
the ASTM website. 650–656.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1830 − 19
dynamic in vitro evaluation of blood pumps is essential, and 6.4 For blood transportation, the temperature can be main-
this recommended practice will allow an acceptable compari- tained with ice packs within the range of 2 to 8 °C. If stored,
son of test results among hemolysis tests involving similar the whole blood can be refrigerated in the range of 2 to 8 °C.
testing methods.
6.5 For in vitro dynamic hemolysis testing, blood is gener-
ally used within 48 hours of blood draw, including the time for
6. Collection and Preparation of Blood
transport. Best consistency may be expected when blood is
6.1 Bovine, porcin
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1830 − 97 (Reapproved 2017) F1830 − 19
Standard Practice for
Selection Collection and Preparation of Blood for Dynamic
in vitro Evaluation of Hemolysis in Blood Pumps
This standard is issued under the fixed designation F1830; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice covers whole blood that will be used for the in vitro performance assessmentsassessment of blood pumps.
These assessments include the hemolytic properties of the devices.hemolysis in blood pumps intended for clinical use.
1.2 This practice covers the utilization of recommended standard collection, preparation, handling, storage, and utilization of
whole blood for the in vitro evaluation (see Practice F1841) of the following devices:
1.2.1 Continuous flow rotary blood pumps (roller pumps, centrifugal pumps, axial flow pumps, and so forth) (see Practice
etc.).F1841).
1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electromechanically driven, and so forth).electro-
mechanically driven, with an artificial pulse, etc.).
1.3 The source and preparation of whole blood utilized for the dynamic in vitro evaluation of blood trauma (that is, hemolysis
red blood cell (erythrocyte) trauma caused by the blood pumps, due to the pump design, construction, and materials used)
substantially influences the results of the blood pumps can substantially influence the hemolysis performance of these devices.
Thus, a standardized blood source is whole blood collection and preparation methods are required.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
F1841 Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps (Withdrawn 0)
2.1 ASTM Standards:
F1841 Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 continuous flow blood pump—a blood pump that produces continuous blood flow due to its rotary motion.device that
replaces or supplements the function of the human heart to circulate blood by producing continuous or time-varying blood flow.
3.1.2 hemolysis—one of the parameters of blood damage caused by a blood pump. This can be observed by a change in the
plasma color and can be measured as an increase of free plasma hemoglobin concentration.pump, characterized by the liberation
of hemoglobin from damaged erythrocytes into the plasma. Hemolysis can occur from mechanical, thermal, or chemical sources
in medical devices.
3.1.3 pulsatile pump—a blood pump that produces blood flow to mimic a natural heart.
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.30
on Cardiovascular Standards.
Current edition approved Sept. 1, 2017Sept. 1, 2019. Published September 2017December 2019. Originally approved in 1997. Last previous edition approved in 20132017
as F1830 – 97 (2013).(2017). DOI: 10.1520/F1830-97R17.10.1520/F1830-19.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1830 − 19
4. Summary of Practice
4.1 For the experimental evaluation of blood pump designs and materials, an hemolysis caused by pump designs, materials, and
operational conditions (see Practice F1841), dynamic in vitro hemolysis test istests are recommended using fresh bovineanimal or
porcinehuman blood. The blood donor animals should have normal an afebrile body temperature, no physical signs or symptoms
of disease, including diarrhea andand/or rhinorrhea, and an acceptable normal range of hematological profiles. The blood from a
slaughterhouse should not be used because it may be contaminated with other body fluids, unless obtained by controlled
venipuncture. However, for the preclinical studies, fresh human blood is recommended for use (see Practiceparameters (e.g. RBC,
WBC, and platelet counts, hematocrit, total hemoglobin concentration). If animal blood is obtained from an abattoir, it is preferable
that it be collected by controlled venipuncture to minimize the risk of contamination with debris or fluids other than blood. While
human blood would be the most relevant for performing preclinical device F1841).studies, the practicality of obtaining sufficient
quantities of cross-matched donor blood needs to be considered.
4.2 For the in vitro hemolysis test, fresh bovine or porcine blood is used within 48 h, including the time for transport. Fresh
human blood should be used within 24 h after blood harvesting. The collected blood should be refrigerated at 2 to 8°C.
5. Significance and Use
5.1 The In vitro hemolysis test results are for blood pumps may be substantially affected by donor species andspecies, sex, age,
fasting, the method of harvesting, the anticoagulant properties, the period of storage, the biochemical state of the blood, and the
3,4
hemoglobin and hematocrit level of blood. Therefore, standardization of proper blood usage for whole blood collection and
preparation for the dynamic in vitro evaluation of blood pumps is essential, and this recommended practice will allow a universalan
acceptable comparison of test results. results among hemolysis tests involving similar testing methods.
5.2 Drawing several units of blood from healthy cattle does not affect them or their health. Therefore, bovine blood is strongly
suggested for usage in experimental evaluation of blood damage. Mixing two donor sources of blood should be avoided in
hemolysis tests because the mixture may induce added hemolysis or a change in red cell resistance against trauma.
6. Collection and Preparation of Blood
6.1 Bovine, porcine, ovine, and human blood have been used as the primary sources of blood for the in vitro dynamic
assessment of blood pumps. Drawing several units of whole blood from healthy large animals (e.g. bovine, porcine, ovine) does
not affect their health. Therefore, large animal blood is strongly suggested for use in the experimental evaluation of hemolysis in
blood pumps. Pooling blood from several donors of a single species is not preferred practice because the mixture may induce added
hemolysis, change red cell resistance against trauma, activate platelets, or induce thrombogenesis.
6.2 If animal blood
...