NF EN 12022 : 1999

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
    4.1 Biological characteristics
    4.2 Physical characteristics
    4.3 Performance characteristics
5 Compliance tests and measurements
    5.1 General
    5.2 Biological characteristics
    5.3 Physical characteristics
    5.4 Performance characteristics
6 Information supplied by the manufacturer
    6.1 Information to be given on the blood-gas
          exchanger
    6.2 Information to be given on the packaging
    6.3 Information to be given in the accompanying
          documents
7 Packaging
Annex A (informative) Bibliography

Defines requirements for single-use, sterile, extracorporeal blood-gas exchangers intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. Applicable to heat exchangers that are integral parts of blood-gas exchangers and to external equipment unique to the use of the device. Not applicable to liquid exchangers, separate heat exchangers, implanted blood-gas exchangers, extracorporeal circuits (blood-tubing), separate ancillary devices.