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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 034 Date of Entry 01/30/2014 
FR Recognition Number 9-89
ISO  8638 Third edition 2010-07-01
Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialyzers, haemodiafilters, and haemofilters
U.S. Identical Adoption
ANSI AAMI ISO 8638:2010 (R2015)
Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
ISO 8638:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section; Section; Section; Section; Section 5.5.9;Section 5.5.10; Section 6.1 NOTE; Section 6.2e NOTE; Section 6.2 NOTE; Section 6.3 NOTE; and Section 6.4 NOTE.
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.

FDA does not recognize these sections listed above because they are intended for quality control in hemodialysis clinics and not intended for a manufacturer to meet premarket requirements for these devices under the FD&C Act.
Transition Period
FDA recognition of ISO 8638 Third edition 2010-07-01 [Rec# 9-89] will be superseded by recognition of ISO 8637-2 First Edition 2018-07 [Rec# 9-140]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-89] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 9-89] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5820 Accessories, Blood Circuit, Hemodialysis Class 2 KOC
§876.5820 Adaptor, Fistula Class 2 FKM
§876.5820 Adaptor, Y Class 2 FJP
§876.5820 Connector, Blood Tubing, Infusion T Class 2 FKB
§876.5820 Connector, Tubing, Dialysate Class 2 FKY
§876.5820 Declotting Tray, Kit (Including Contents) Class 2 FJZ
§876.5820 Filter, Blood, Dialysis Class 2 FKJ
§876.5820 Protector, Transducer, Dialysis Class 2 FIB
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump Class 2 FIF
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed Class 2 NNG
§876.5820 Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Class 2 FJK
§876.5820 System Accessories, Extracorporeal Class 2 KXM
§876.5820 System, Blood, Extracorporeal And Accessories Class 2 LLB
§876.5820 Tray, Start/Stop (Including Contents), Dialysis Class 1 FKG
§876.5820 Tubing, Dialysate Class 2 FID
§876.5820 Tubing, Dialysate (And Connector) Class 2 KQQ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process, Issued June 2016.

Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions, Issued April 2008.

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 Contact
 Gema Gonzalez
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.