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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 063 Date of Entry 12/23/2024 
FR Recognition Number 3-194
Standard
ISO  7199 Fourth edition 2024-09
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Scope/Abstract
This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange.

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.

This document does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filters.
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FDA recognition of ISO 7199 Third edition 2016-11-15 [Rec# 3-150] will be superseded by recognition of ISO 7199 Fourth edition 2024-09 [Rec# 3-194]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-150] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 3-150] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.4100 Oxygenator, Long Term Support Greater Than 6 Hours Class 2 BYS
§870.4150 Extracorporeal System For Carbon Dioxide Removal Class 2 QOH
§870.4350 Oxygenator, Cardiopulmonary Bypass Class 2 DTZ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Cardiopulmonary Bypass Oxygenators 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
  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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