ISO 7199:2016
Withdrawn
View Superseded by
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Hardcopy , PDF
English, French
11-07-2016
04-09-2025
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.
| Committee |
ISO/TC 150/SC 2
|
| DevelopmentNote |
Supersedes ISO/DIS 7199. (11/2016) NEW CHILD AMD 1 2020 IS ADDED.
|
| DocumentType |
Standard
|
| Pages |
13
|
| ProductNote |
NEW CHILD AMD 1 2020 IS ADDED.
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| AAMI ISO 7199 : 2009 | Identical |
| NF EN ISO 7199 : 2017 | Identical |
| NS EN ISO 7199 : 2017 | Identical |
| I.S. EN ISO 7199:2017 | Identical |
| PN EN ISO 7199 : 2017 | Identical |
| SS-EN ISO 7199 : 2017 | Identical |
| BS EN ISO 7199:2017 | Identical |
| EN ISO 7199:2017 | Identical |
| DIN EN ISO 7199:2015-06 (Draft) | Identical |
| ANSI/AAMI/ISO 7199:2016 | Identical |
| NEN-EN-ISO 7199:2017 | Identical |
| DS EN ISO 7199 : 2017 | Identical |
| ABNT NBR ISO 7199:2018 | Identical |
| UNE-EN ISO 7199:2017 | Identical |
| NBN EN ISO 7199 : 2014 | Identical |
| GOST R ISO 7199 : 2010 | Identical |
| UNE-EN ISO 7199:2015 | Identical |
| BS ISO 7199 : 2009 | Identical |
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