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AAMI/ISO 7199:2016
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)More info
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. Also applies to heat exchangers and arterials filters that are integral parts of the oxygenator. Also applies to external equipment unique to the use of the device.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-12-06 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Replace | ANSI/AAMI/ISO 7199 (2009) |
| Cross references | ISO 7199 (2016-11), IDT |
| Year | 2016 |
| Document history | ANSI/AAMI/ISO 7199 (2016) |
| Country | USA |
| Keyword | ANSI 7199;7199;ANSI/AAMI/ISO 7199-2016 |