DS/EN ISO 7199
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
inactive
| Organization: | DS |
| Publication Date: | 25 August 2014 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
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.
Document History
April 6, 2020
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) – Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
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...
February 2, 2017
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO 7199:2016)
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...
DS/EN ISO 7199
August 25, 2014
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
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...
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) – Amendment 1: Connectors (ISO 7199:2016/DAM 1:2018)
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...
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)
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...
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) – Amendment 1: Connectors (ISO 7199:2016/FDAM 1:2019)
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...
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2015)
This International 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...
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Clarifications for test methodologies, labelling, and sampling schedule (ISO 7199:2009 + Amd 1:2012)
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...
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO/FDIS 7199:2016)
This International 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...