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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 3-56
Standard
ASTM F1841-97 (Reapproved 2017)
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps egg
Scope/Abstract
This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h.
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.
Transition Period
FDA recognition of ASTM F1841-97 (Reapproved 2017) [Rec# 3-56] will be superseded by recognition of ASTM F1841-19 [Rec# 3-165]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-56] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 3-56] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.4360 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class 2 KFM
§870.4370 Pump, Blood, Cardiopulmonary Bypass, Roller Type Class 2 DWB
FDA Technical Contacts
 Jean E. Rinaldi
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2523
  jean.rinaldi@fda.hhs.gov
 Richard Malinauskas
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2506
  RICHARD.MALINAUSKAS@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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