DS/EN ISO 7199:2017/A1:2020

Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) – Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 56.89

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: 20

Published: 2020-04-08

Date of approval: 2020-04-06

International relationships : EN ISO 7199:2017/A1:2020 IDT ISO 7199:2016/Amd 1:2020 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M323581


Committees

Committee

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

Danish committee

DS/S-093