Historical

ISO 13960:2003

Cardiovascular implants and artificial organs - Plasmafilters


ISO 13960:2003 specifies requirements for sterile, single-use plasmafilters, intended for use on humans.

ISO 13960:2003 is not applicable to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices.

ISO 13960:2003 does not address the replacement fluid.


CONTENT PROVIDER
International Organization for Standardization [iso]

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Document History
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Amendments & Corrections
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