ISO 8637-1 First edition 2017-11

Cardiovascular Implants And Extracorporeal Systems--Hemodialyzers, Hemodiafilters, Hemofilters And Hemoconcentrators

8637:2010 (R2015)

Standard Organization: ANSI AAMI ISO

ISO 8637-1 First edition 2017-11
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Recognition NumberObGyn/Gastroenterology/Urology
Recognition Date2018-09-17
Recognition List050
Recognition Number9-118
Extent 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.
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG ObGyn/Gastroenterology/Urology
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Rationale:

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.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§876.5860 Dialyzer, High Permeability With Or Without Sealed Dialysate System Class 2 KDI
§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

FDA Guidance:

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.



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