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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 3-164
Standard
ASTM  F1830-19
Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3545 Ventricular Bypass (Assist) Device Class 3 OKR
§870.4360 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class 2 KFM
§870.4370 Pump, Blood, Cardiopulmonary Bypass, Roller Type Class 2 DWB
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Richard Malinauskas
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2506
  RICHARD.MALINAUSKAS@FDA.HHS.GOV
 Jean E. Rinaldi
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2523
  jean.rinaldi@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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