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ISO 15674:2016
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ISO 15674:2016
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bagsMore info
ISO 15674:2016 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.
It 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 | ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics
|
| Number of pages | 11 |
| Replace | ISO 15674:2009 |
| Modified by | ISO 15674:2016/FDAmd 1 |
| Weight(kg.) | 0.1187 |
| Year | 2016 |
| Country | Switzerland |