What is ISO 8637‑1 about?
ISO 8637 discusses extracorporeal systems for blood purification. ISO 8637‑1 outlines requirements for haemodialyser, haemodiafilter, haemofilter, and haem concentrators, hereinafter collectively referred to as “the device”, for use in humans.
It was not found practicable to specify materials of construction. ISO 8637‑1, therefore, requires only those materials which have been used have been tested and that the methods and results are made available upon request.
Who is ISO 8637‑1 for?
ISO 8637‑1 on extracorporeal systems for blood purification is useful for:
- Manufacturers of devices for Extracorporeal systems for blood purification
- Test centres and healthcare clinic
- Hospitals
- Regulatory authorities
Why should you use ISO 8637‑1?
Blood compartment part of a haemodialyser, haemodiafilter, haemofilter, or haemoconcentration through which blood is intended to pass. Haemoconcentration process whereby plasma water and electrolytes are removed from diluted blood across a semipermeable membrane.
ISO 8637‑1 guideline provides general requirements and test methods on biological safety, sterility, non-pyrogenicity, and mechanical characteristics on extracorporeal systems for blood purification. ISO 8637‑1 also outlines the labelling on the device, unit container, outer container, and information to be given in accompanying documents for extracorporeal systems for blood purification. This ensures compatibility and minimises the risk of leakage of blood and ingress of air.
What’s changed since the last update?
BS EN ISO 8637‑1:2020 supersedes ISO 8637‑1:2017, which has been withdrawn. In BS EN ISO 8637‑1:2020, figure 1, figure 2, and figure 3 have been revised with respect to ISO 8637‑1:2017.
