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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 062 Date of Entry 05/29/2024 
FR Recognition Number 3-191
Standard
ISO  18242 First edition 2016-09-01 [Including AMD1:2023]
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)]
Scope/Abstract
This document specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or 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, or extracorporeal membrane oxygenation.

This document does not apply to

- centrifugal pumps used as ventricular assist devices, and

- other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
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FDA recognition of ISO 18242 First edition 2016-09-01 [Rec# 3-163] will be superseded by recognition of ISO 18242 First edition 2016-09-01 [Including AMD1:2023] [Rec# 3-191]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-163] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 3-163] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.4360 Nonroller-type blood pump.
Relevant FDA Guidance and/or Supportive Publications*
ASTM F1841-19e1 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps.

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
 Catherine Wentz
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-6339
  catherine.wentz@fda.hhs.gov
 Qijin Lu
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2528
  qijin.lu@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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