NF S93-302*NF EN ISO 8637:2014 PDF

Scope: This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators, collectively hereinafter referred to as "devices", for use in humans. This International Standard is not applicable to: 　——extracorporeal blood circuits; 　——plasmafilters; 　——hemoperfusion devices; 　——vascular access devices; 　——blood pumps; 　——extracorporeal blood circuit pressure monitors; 　——air detection devices; 　——systems for preparation, preservation or control of the dialysis liquid; 　——to the systems used to carry out hemodialysis a

NF S93-302*NF EN ISO 8637:2014 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
ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

2018 NF S93-302-2*NF EN ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2 : extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
0000 NF S93-302:2014
1996 NF S93-302:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits.