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 AdoptionANSI AAMI ISO 11658: 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
|
Scope/AbstractThis 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
|
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
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |
|
|