ISO/FDIS 8637-3
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Extracorporeal systems for blood purification — Part 3: Plasmafilters
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31-05-2024
English
09-02-2024
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This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to;
systems or equipment intended to perform plasma separation.
NOTE1 Requirements for the extracorporeal blood circuit are specified in ISO8637-2.
NOTE2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO8637-1.
| Committee |
ISO/TC 150/SC 2
|
| DocumentType |
Draft
|
| Pages |
18
|
| PublisherName |
International Organization for Standardization
|
| RevisionOf | |
| Status |
Superseded
|
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