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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 053 Date of Entry 12/23/2019 
FR Recognition Number 3-163
Standard
ISO  18242 First edition 2016-09-01
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps.
Scope/Abstract
ISO 18242:2016 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.

It 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
Partial recognition. The following part(s) of the standard is (are) not recognized:
Table 2 Sampling Schedule in Section 5.4.2.2. Procedure.
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.

Table 2 is in conflict with another recognized standard, see Subclause 8.5 of ASTM F1841-97 (Reapproved 2017) cited below.
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 - 97(Reapproved 2017) 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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