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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 9-140
ISO  8637-2 First Edition 2018-07
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
U.S. Identical Adoption
ANSI AAMI ISO 8637-2:2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.

This document does not apply to:
- haemodialysers, haemodiafilters or haemofilters;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
The following part(s) of the standard is (are) not recognized:
- Clause Integral transducer protectors
- Clause Non-integral transducer protectors
- Clause Needle access ports
- Clause 5.5.9 Transducer protectors
- Clause 5.5.10 Blood pathway flow dynamics
- Clause 5.5.11 Pump segment performance
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.

This standard is recognized in part because:
Clauses,,, 5.5.9, 5.5.10 and 5.5.11 are in conflict with Section 7 of the Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions guidance (Ref #2).
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FDA recognition of ISO 8638 Third edition 2010-07-01 [Rec# 9-89] will be superseded by recognition of ISO 8637-2 First Edition 2018-07 [Rec# 9-140].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*
1. FDA Final Rule, Use of Symbols in Labeling, 21 C.F.R. § 660, 801, 809 (2016).

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