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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 050 Date of Entry 09/17/2018 
FR Recognition Number 9-118
ISO  8637-1 First edition 2017-11
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
U.S. Identical Adoption
ANSI AAMI ISO 8637-1:2017
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans. Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and
haemofilters are specified in ISO 8637-2.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 6.2h Labelling on unit containers - a statement of sterility and non-pyrogenicity.
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:

Section 6.2h contains a test method and/or specification that is not scientifically acceptable. See Section VI Test-Specific Considerations of the 2016 guidance document cited below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5820 Dialyzer, Capillary, Hollow Fiber Class 2 FJI
§876.5820 Dialyzer, Parallel Flow Class 2 FJG
§876.5820 Dialyzer, Single Coil Class 2 FHS
§876.5820 Dialyzer, Twin Coil Class 2 FJJ
§876.5820 Filter, Blood, Dialysis Class 2 FKJ
§876.5860 Dialyzer, High Permeability With Or Without Sealed Dialysate System Class 2 KDI
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 CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, Issued on August 1998.

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.