AAMI RD17 : 2007

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

Describes the requirements for single-use extracorporeal blood circuit (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration, and hemofiltration.