DS/EN ISO 7199:2017

Kardiovaskulære implantater og kunstige organer - Oxygenatorer


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 555,00

Beskrivelse

ISO 7199:2016 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.

ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.

ISO 7199:2016 does not apply to

- implanted oxygenators,

- liquid oxygenators,

- extracorporeal circuits (blood tubing),

- separate heat exchangers,

- separate ancillary devices, and

- separate arterial line filter.


Antal sider: 32

Udgivet: 2017-02-20

Godkendelsesdato: 2017-02-02

Internationale relationer : EN ISO 7199:2017 IDT ISO 7199:2016 IDT

ICS: 11.040.40 - Implantater til kirurgi, protetik og ortoptik

Varenummer: M297070


Udvalg og komiteer

Komite

  • CEN/TC 205
  • ISO/TC 150/SC 2
  • ISO/TC 150/SC 2/WG 4

Dansk udvalg

DS/S-093