ISO/DIS 7199

Abstract

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.

General information

Status
: Under development
Edition
: 4

Number of pages
: 14
Technical Committee
: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
ICS
:
11.040.40 Implants for surgery, prosthetics and orthotics