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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 049 Date of Entry 06/07/2018 
FR Recognition Number 3-150
ISO  7199 Third edition 2016-11-15
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
Identical Adoption
ANSI AAMI ISO 7199:2016
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
This document also applies to external equipment unique to the use of the oxygenator.
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
§870.4350 Oxygenator, Cardiopulmonary Bypass Class 2 DTZ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Cardiopulmonary Bypass Oxygenator 510(k) Submissions; Final Guidance for Industry and FDA Staff, Issued November 2000.

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
 Qijin Lu
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.