ISO 7199:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Hardcopy , PDF
English, French
07-11-2016
09-04-2025
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Withdrawn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 |
A newer version of this standard is available.
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