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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>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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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

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.


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