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90.92 Standard to be revised Feb 21, 2023
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Published
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply 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 dialysis fluid;
- systems or equipment intended 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 8637‑2.
PUBLISHED
ISO 8637-1:2017
90.92
Standard to be revised
Feb 21, 2023