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AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)More info
Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short- term, i.e. < 6 h duration) CPB surgery, or (long-term, i.e. > 24 h) ECMO procedures. The sterility and non- pyrogenicity provisions of this standard are applicable to tubing packs labelled as 'sterile'.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-11-07 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Cross references | ISO 15676 (2016-08), IDT |
| Year | 2016 |
| Document history | |
| Country | USA |
| Keyword | ANSI 15676;15676;ANSI/AAMI/ISO 15676-2016 |