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BS ISO 15674:2016+A1:2020
Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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| Označení normy: | BS ISO 15674:2016+A1:2020 |
| Počet stran: | 28 |
| Vydáno: | 2020-02-19 |
| ISBN: | 978 0 580 51825 6 |
| Status: | Standard |
DESCRIPTION
BS ISO 15674:2016+A1:2020
This standard BS ISO 15674:2016+A1:2020 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags is classified in these ICS categories:
- 11.040.40 Implants for surgery, prosthetics and orthotics
This document 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.
This document 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.