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BS EN ISO 7199:2016+A1:2020

Current

Current

The latest, up-to-date edition.

Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-04-2020

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.

This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

This document also applies to external equipment unique to the use of the oxygenator.

This document does not apply to

  • implanted oxygenators,

  • liquid oxygenators,

  • extracorporeal circuits (blood tubing),

  • separate heat exchangers,

  • separate ancillary devices, and

  • separate arterial line filter.

Committee
CH/150/2
DocumentType
Standard
ISBN
9780580518249
Pages
36
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 7199:2017/A1:2020 Identical
ISO 7199:2016/Amd 1:2020 Identical

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