ISO 8637:2004 PDF

Scope: This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use for humans. This International Standard is not applicable to — extracorporeal blood circuits, — plasmafilters, — haemoperfusion devices, — vascular access devices, — blood pumps, — pressure monitors for the extracorporeal blood circuit, — air detection devices, — systems to prepare, maintain or monitor dialysate, — systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration, — reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are specified in ISO 8638.

ISO 8637:2004 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1*， 2009-11-01 Update
ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 8638 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters*， 2010-07-01 Update

2013 ISO 8637:2010/Amd 1:2013 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
2010 ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
2004 ISO 8637:2004 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
1989 ISO 8637:1989 Haemodialysers, haemofilters and haemoconcentrators