BS 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.

This European Standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.

This European Standard also applies to heat exchangers that are integral parts of blood-gas exchangers and to external equipment unique to the use of the device.

This European Standard does not apply to:

• implanted blood-gas exchangers;

• liquid exchangers;

• extracorporeal circuits (blood tubing);

• separate heat exchangers;

• separate ancillary devices.