ISO 8638; Cardiovascular Implants and Extracorporeal
ISO 8638; Cardiovascular Implants and Extracorporeal Systems – Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
ISO 8638 Introduction
This International Standard is concerned with the extracorporeal blood circuit manufactured for single use and intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements specified in this International Standard for the extracorporeal blood circuit will help to ensure safety and satisfactory function. It was not found practicable to specify materials of construction. This International Standard therefore requires only that materials have been tested and that the methods and results are made available upon request. The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been specified to ensure compatibility with these devices, as specified in ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood and ingress of air. Connectors with either fixed or loose locking shells are permitted. This International Standard reflects the consensus of physicians, manufacturers and other interested parties for devices that are approved for clinical use.
ISO 8638 Scope
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators and transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This specification also lays out the test requirements and defines the gages and reference fittings.
This International Standard does not apply to:
- haemodialysers, haemodiafilters or haemofilters
- 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
NOTE: Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
Original Posting: 10/30/2012
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