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AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bagsMore info
Specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery. Applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
| 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 |
| Replace | ANSI/AAMI/ISO 15674 (2009) |
| Cross references | ISO 15674 (2016-08), IDT |
| Year | 2016 |
| Document history | ANSI/AAMI/ISO 15674 (2016) |
| Country | USA |
| Keyword | ANSI 15674;15674;ANSI/AAMI/ISO 15674-2016 |