- Standard No.
- EN ISO 8638:2014
- Release Date
- 2014
- Published By
- European Committee for Standardization (CEN)
- Latest
-
EN ISO 8638:2014
- Replace
-
FprEN ISO 8638:2013
- Scope
- This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators (hereinafter referred to as "the device") and transducer protectors (integral and non-integral) for use in hemodialysis, hemodiafiltration and hemofiltration. This International Standard is not applicable to: hemodialyzers, hemodiafilters or hemofilters; plasma filter; hemooperfusion devices; vascular access devices; Pump blood; pressure recording devices for extracorporeal blood circuits; air detection devices; Systems for the production, storage or monitoring of dialysis fluid; Systems or equipment for performing hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration. NOTE Requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators are specified in ISO 8637.
EN ISO 8638:2014 Referenced Document
- ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 7864:1993 Sterile hypodermic needles for single use
EN ISO 8638:2014 history
- 2014 EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters
EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters has been changed from EN 1283:1996 Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits.