Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 8638:2004
U.S. deviations to ISO 8638:2004
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Nonpyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
4.4.2 Connection to hemodialyzer, hemodiafilter,
or hemofilter
4.4.3 Connection to vascular access device
4.4.4 Connection to ancillary components
4.4.5 Color coding
4.4.6 Access ports
4.4.7 Blood pathway volume
4.4.8 Air-capture chamber fill level
4.4.9 Transducer protectors
4.4.10 Blood pathway flow dynamics
4.4.11 Pump segment performance
4.5 Expiration date
4.6 Tubing compliance
5 Test methods
5.1 General
5.2 Biological safety
5.3 Sterility
5.4 Nonpyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity test
5.5.2 Connectors to hemodialyzer, hemodiafilter,
or hemofilter
5.5.3 Connector to vascular access device
5.5.4 Connectors to ancillary components
5.5.5 Color coding
5.5.6 Access ports
5.5.7 Blood pathway volume
5.5.8 Air-capture chamber fill level
5.5.9 Transducer protectors
5.5.10 Blood pathway flow dynamics
5.5.11 Pump segment performance
5.6 Expiration date
5.7 Tubing compliance
6 Labeling
6.1 Labeling on the device
6.2 Labeling on the unit container
6.3 Labeling on the outer container
6.4 Accompanying documentation
Annex A (informative) - Rationale for the development
and provisions of this standard
Bibliography