DS/EN ISO 7199:2014 ( Withdrawn )

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 60.97

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.


Number of pages: 28

Published: 2014-09-04

Date of approval: 2014-08-25

Date of withdrawal: 2017-02-20

International relationships : EN ISO 7199:2014 IDT ISO 7199:2009 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M279709


Committees

Committee

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

Danish committee

DS/S-093