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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 059 Date of Entry 12/19/2022 
FR Recognition Number 3-183
ISO  11658 First edition 2012-05-15
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Identical Adoption
ANSI AAMI ISO 11658: 2012
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device.

The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.
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
§870.1250 Catheter, Percutaneous Class 2 DQY
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§870.4100 Oxygenator, Long Term Support Greater Than 6 Hours Class 2 BYS
§870.4100 Dual Lumen Ecmo Cannula Class 2 PZS
§870.4100 Single Lumen Ecmo Cannula Class 2 QHW
§870.4100 Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Class 2 QJZ
§870.4210 Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class 2 DWF
§870.4230 Defoamer, Cardiopulmonary Bypass Class 2 DTP
§870.4240 Heat-Exchanger, Cardiopulmonary Bypass Class 2 DTR
§870.4260 Filter, Blood, Cardiopulmonary Bypass, Arterial Line Class 2 DTM
§870.4270 Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass Class 2 JOD
§870.4350 Oxygenator, Cardiopulmonary Bypass Class 2 DTZ
§870.4360 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class 2 KFM
§870.4390 Tubing, Pump, Cardiopulmonary Bypass Class 2 DWE
§870.4400 Reservoir, Blood, Cardiopulmonary Bypass Class 2 DTN
§880.5200 Catheter, Umbilical Artery Class 2 FOS
§880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class 2 FOZ
§880.5200 Saline, Vascular Access Flush Class 2 NGT
§880.5200 Heparin, Vascular Access Flush Class 2 NZW
§880.5200 Water, Vascular Access Flush Class 2 NZX
§880.5200 Peripheral Catheter Insertion Kit Class 2 OWL
§880.5200 Heparin Flush In 0.45% Sodium Chloride Class 2 PEF
§880.5200 Central Venous Catheter Dressing Change Kit Class 2 PEZ
§880.5970 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class 2 LJS
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.

Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA, 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
 Qijin Lu
 Catherine Wentz
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.