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.
Registration number (WIID)
9396
Scope
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.
