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

This European Standard specifies requirements for sterile, single-use, extracorporeal blood gas exchangers intended for supply of oxygen to, and removal of carbon dioxid 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 (blod tubing); - separate heat exchangers; - separate ancillary devices.