AAMI RD16 : 2007

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 8637:2004
U.S. Deviations to ISO 8637:2004
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and 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 Blood compartment integrity
      4.4.3 Hemodialyzer, hemodiafilter, and
            hemofilter blood compartment ports
      4.4.4 Hemodialyzer or hemodiafilter dialysate
            compartment ports
      4.4.5 Hemofilter filtrate ports
      4.4.6 Hemoconcentrator blood and filtrate ports
  4.5 Performance characteristics
      4.5.1 Clearance of hemodialyzers and hemodiafilters
      4.5.2 Sieving coefficient of hemodiafilters,
            hemofilters, and hemoconcentrators
      4.5.3 Filtration rate
      4.5.4 Volume of the blood compartment
      4.5.5 Pressure drop
  4.6 Expiration date
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
      5.5.2 Blood compartment integrity
      5.5.3 Hemodialyzer, hemofilter, and hemodiafilter
            blood compartment ports
      5.5.4 Hemodialyzer or hemodiafilter dialysate
            compartment ports
      5.5.5 Hemofilter filtrate ports
      5.5.6 Hemoconcentrator blood and filtrate ports
  5.6 Performance characteristics
      5.6.1 Clearance
      5.6.2 Sieving coefficient for hemofilters,
            hemodiafilters, and hemoconcentrators
      5.6.3 Filtration rate
      5.6.4 Volume of the blood compartment
      5.6.5 Pressure drop
  5.7 Expiration date
6 Labeling
  6.1 Labeling on the device
  6.2 Labeling on the unit containers
  6.3 Labeling on the outer containers
  6.4 Accompanying documentation
Annex A (informative) - Rationale for the development
                        and provisions of this standard
Bibliography

Describes the requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators hereinafter collectively referred to as "the device," for use for humans.