1Key Takeaways
This International Standard specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
This International Standard is not applicable…
2Scope / Description
This International Standard specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
This International Standard is not applicable to
— haemodialysers, haemodiafilters or haemofilters,
— plasmafilters,
— haemoperfusion devices,
— vascular access devices,
— blood pumps,
— pressure monitors for the extracorporeal blood circuit,
— air detection devices,
— systems to prepare, maintain or monitor dialysing fluid,
— systems intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
5Citation Network
Standards that cite ISO 8638:2004
6Frequently Asked Questions
What is ISO 8638:2004?
ISO 8638:2004 — Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters is an international standard developed by International Organization for Standardization (ISO). This International Standard specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis,...
What does ISO 8638:2004 cover?
This standard covers: This International Standard specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International...
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 ISO 8638:2004?
The current published version is ISO 8638:2004, published on 2004-10. Always check for amendments or pending revisions.
How do I purchase ISO 8638:2004?
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