BS EN ISO 7199:2016+A1:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
Hardcopy , PDF
25-09-2024
English
06-04-2020
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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.
| Committee |
CH/150/2
|
| DocumentType |
Standard
|
| ISBN |
9780580518249
|
| Pages |
36
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| ISO 7199:2016/Amd 1:2020 | Identical |
| EN ISO 7199:2017/A1:2020 | Identical |
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