| ISO 8638 Third edition 2010-07-01 Cadiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 9-89 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Section 4.4.9.1; Section 4.4.9.2; Section 5.5.6.1; Section 5.5.6.2; 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. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Carolyn Neuland FDA/OMPT/CDRH/ODE/DRGUD/RNDB/ 301-796-6523 carolyn.neuland@fda.hhs.gov |
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.
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.
| 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 |
| 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. |