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immediate downloadReleased: 2020-02-19
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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Standard number: | BS ISO 15674:2016+A1:2020 |
Pages: | 28 |
Released: | 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.