| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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9-140
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| Standard | |
ISO 8637-2 First Edition 2018-07
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
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Identical AdoptionANSI AAMI ISO 8637-2:2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
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Scope/AbstractThis 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. |
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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 4.4.9.1 Integral transducer protectors
- Clause 4.4.9.2 Non-integral transducer protectors
- Clause 5.5.6.1 Needle access ports
- Clause 5.5.9 Transducer protectors
- Clause 5.5.10 Blood pathway flow dynamics
- Clause 5.5.11 Pump segment performance |
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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 4.4.9.1, 4.4.9.2, 5.5.6.1, 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). |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5820 |
Protector, Transducer, Dialysis
|
Class 2
|
FIB
|
| §876.5820 |
Tubing, Dialysate
|
Class 2
|
FID
|
| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump
|
Class 2
|
FIF
|
| §876.5820 |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
Class 2
|
FJK
|
| §876.5820 |
Adaptor, Y
|
Class 2
|
FJP
|
| §876.5820 |
Declotting Tray, Kit (Including Contents)
|
Class 2
|
FJZ
|
| §876.5820 |
Connector, Blood Tubing, Infusion T
|
Class 2
|
FKB
|
| §876.5820 |
Tray, Start/Stop (Including Contents), Dialysis
|
Class 1
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FKG
|
| §876.5820 |
Filter, Blood, Dialysis
|
Class 2
|
FKJ
|
| §876.5820 |
Adaptor, Fistula
|
Class 2
|
FKM
|
| §876.5820 |
Connector, Tubing, Dialysate
|
Class 2
|
FKY
|
| §876.5820 |
Accessories, Blood Circuit, Hemodialysis
|
Class 2
|
KOC
|
| §876.5820 |
Tubing, Dialysate (And Connector)
|
Class 2
|
KQQ
|
| §876.5820 |
System Accessories, Extracorporeal
|
Class 2
|
KXM
|
| §876.5820 |
System, Blood, Extracorporeal And Accessories
|
Class 2
|
LLB
|
| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
|
Class 2
|
NNG
|
|
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
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
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| *These are provided as examples and others may be applicable. |
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