Standard: AAMI 8638
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS — EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
This standard is available for individual purchase.
IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).FEATURES & BENEFITS
- Maximize product development and R&D with direct access to over 1.6 million standards
- Discover new markets: Identify unmet needs and discover next-generation technologies
- Improve quality by leveraging consistent standards to meet customer and market requirements
- Minimize risk: Mitigate liability and better understand compliance regulations
- Boost efficiency: Speed up research, capture and reuse expertise
HOW TO SUBSCRIBE
This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration.
This International Standard does not apply to:
— hemodialyzers, hemodiafilters or hemofilters;
— hemoperfusion 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 hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration.
NOTE Requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators are specified in ISO 8637.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 8638|
|Most Recent Revision:||YES|
This Standard References
Showing 10 of 18.
Standards That Reference This Standard
Showing 1 of 1.