ISO 8637-3:2024
Current
The latest, up-to-date edition.
Extracorporeal systems for blood purification — Part 3: Plasmafilters
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English
31-05-2024
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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 |
Standard
|
| Pages |
18
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DS/ISO 8637-3:2024 | Identical |
| BS ISO 8637-3:2024 | Identical |
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