DS/EN ISO 7199
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO 7199:2016)
active, Most Current
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| Organization: | DS |
| Publication Date: | 2 February 2017 |
| Status: | active |
| Page Count: | 32 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
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.
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...
DS/EN ISO 7199
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...
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...