Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

059

Date of Entry 12/19/2022

FR Recognition Number

3-183

Standard

ISO 11658 First edition 2012-05-15
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

U.S. Identical Adoption

ANSI AAMI ISO 11658: 2012
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

Scope/Abstract

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
§870.4270	Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	Class 2	JOD
§880.5200	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class 2	FOZ
§880.5200	Catheter, Umbilical Artery	Class 2	FOS
§880.5200	Central Venous Catheter Dressing Change Kit	Class 2	PEZ
§880.5200	Heparin Flush In 0.45% Sodium Chloride	Class 2	PEF
§880.5200	Heparin, Vascular Access Flush	Class 2	NZW
§880.5200	Peripheral Catheter Insertion Kit	Class 2	OWL
§880.5200	Saline, Vascular Access Flush	Class 2	NGT
§880.5200	Water, Vascular Access Flush	Class 2	NZX
§880.5970	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class 2	LJS
§870.1250	Catheter, Angioplasty, Peripheral, Transluminal	Class 2	LIT
§870.1250	Catheter, Percutaneous	Class 2	DQY
§870.4100	Dual Lumen Ecmo Cannula	Class 2	PZS
§870.4100	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Class 2	QJZ
§870.4100	Oxygenator, Long Term Support Greater Than 6 Hours	Class 2	BYS
§870.4100	Single Lumen Ecmo Cannula	Class 2	QHW
§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
§870.4350	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

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

FDA/OC/CDRH/OSEL/DAM/

301-796-2528

qijin.lu@fda.hhs.gov

Catherine Wentz

FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/

301-796-6339

catherine.wentz@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization