DS/EN ISO 7199:2017

Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO 7199:2016)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64

Scope

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.


Number of pages: 32

Published: 2017-02-20

Date of approval: 2017-02-02

International relationships : EN ISO 7199:2017 IDT ISO 7199:2016 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M297070


Committees

Committee

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

Danish committee

DS/S-093