Abstract
PreviewISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.
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Status: PublishedPublication date: 2017-11
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Edition: 1Number of pages: 22
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- ICS :
- 11.040.40 Implants for surgery, prosthetics and orthotics
Buy this standard
Format | Language | |
---|---|---|
std 1 124 | PDF + ePub | |
std 2 124 | Paper |
- CHF124
Life cycle
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Previously
WithdrawnISO 8637:2010
WithdrawnISO 8637:2010/Amd 1:2013
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Now
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Will be replaced by
Under developmentISO/DIS 8637-1
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