ISO 8637:1989
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Haemodialysers, haemofilters and haemoconcentrators
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
12-09-2018
English, French
06-07-1989
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 8637:1989 specifies requirements for haemodialysers, including those of coil, hollow-fibre and parallel-plate design, haemofilters and haemoconcentrators for single use for humans. Requirements for materials of construction and test methods for biocompatibility, validation of sterility, non-pyrogenicity and certain performance characteristics are not included.
ISO 8637:1989 does not apply to devices assembled and sterilized by the user, nor to devices for the extracorporeal blood circuit, plasma filters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors of the extracorporeal circuit, air detection devices or systems to prepare, maintain or monitor dialysing fluid.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
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