Standard

DS/EN ISO 7199:2014 - Tilbagetrukket

Kardiovaskulære implantater og kunstige organer – Oxygenatorer

Status
TilbagetrukketTilbagetrukket
Type
Standard
Varenummer
M279709
Udgivelsesdato
2014-09-04
Komite

CEN/TC 205

ISO/TC 150/SC 2

International arbejdsgruppe WG

CEN/TC 205

ISO/TC 150/SC 2

Internationale relationer
Tooltip
ISO 7199:2009 IDT, EN ISO 7199:2014 IDT
Dansk udvalg
Antal sider
28
Under revision

Scope

This standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This standard also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device. This standard does not apply to: ⎯ implanted oxygenators; ⎯ liquid oxygenators; ⎯ extracorporeal circuits (blood tubing); ⎯ separate heat exchangers; ⎯ separate ancillary devices.