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Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters


Document Number: ISO 8638:2004
File Size: 282 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $73.00
Product Details

ISO 8638:2004 specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as the device) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. ISO 8638:2004 is not applicable to haemodialysers, haemodiafilters or haemofilters, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysing fluid, or systems intended to perform haemofiltration or haemoconcentration. Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.

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