95.99 Withdrawal of Standard Jun 28, 2010
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Withdrawn
ISO 8637:2004 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as 'the device', for use for humans.
ISO 8637:2004 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 haemofiltration or haemoconcentration, reprocessing procedures and equipment.
Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are specified in ISO 8638.
WITHDRAWN
ISO 8637:1989
WITHDRAWN
ISO 8637:2004
95.99
Withdrawal of Standard
Jun 28, 2010
WITHDRAWN
ISO 8637:2010