1Key Takeaways
This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators, hereinafter collectively referred to as "the device," for use in humans. This International Standard does not apply to: extracorporeal blood circuits; plasma filters; hemoperfusion devices; vascular…
2Scope / Description
This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators, hereinafter collectively referred to as "the device," for use in humans. This International Standard does not apply to: extracorporeal blood circuits; plasma filters; hemoperfusion devices; vascular access devices; blood pumps; pressure recording devices for extracorporeal blood circuits; air detection devices; systems for the preparation, storage, or monitoring of dialysis fluid; systems for performing hemodialysis, hemodiafiltration, hemofiltration, or hemoconcentration; or reprocessing procedures and equipment.
3Version History
DIN EN ISO 8637:2013
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5Citation Network
Standards that cite DIN EN ISO 8637:2014
Referenced by DIN EN ISO 8637:2014
DIN EN ISO 10993-11:2009
DIN EN ISO 10993-1:2010
DIN EN ISO 10993-4:2009
DIN EN ISO 10993-7:2009
ISO 10993-11:2006
ISO 10993-1:2009
ISO 10993-4:2002
ISO 10993-7:2008
6Frequently Asked Questions
What is DIN EN ISO 8637:2014?
DIN EN ISO 8637:2014 — Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014 is an international standard developed by German Institute for Standardization. This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators, hereinafter collectively referred to as "the device," for use in humans. This International Standard does not apply to:...
What does DIN EN ISO 8637:2014 cover?
This standard covers: This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators, hereinafter collectively referred to as "the device," for use in humans. This International Standard does not apply to: extracorporeal blood circuits; plasma filters;...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of DIN EN ISO 8637:2014?
The current published version is DIN EN ISO 8637:2014, published on 2014-03. Always check for amendments or pending revisions.
How do I purchase DIN EN ISO 8637:2014?
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