If you have difficulty in submitting comments on draft standards you can use a commenting template and email it to admin.start@bsigroup.com. The commenting template can be found here.
Standards Development
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
— reprocessing procedures and equipment.
NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
You are now following this standard. Weekly digest emails will be sent to update you on the following activities:
You can manage your follow preferences from your Account. Please check your mailbox junk folder if you don't receive the weekly email.
You have successfully unsubscribed from weekly updates for this standard.
Comment on proposal
Required form fields are indicated by an asterisk (*) character.