Abstract
ISO 7199:2016 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.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filter.
General information
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Status: PublishedPublication date: 2016-11Stage: International Standard to be revised [90.92]
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Edition: 3Number of pages: 13
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Technical Committee :ISO/TC 150/SC 2ICS :11.040.40
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Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Life cycle
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Previously
WithdrawnISO 7199:2009
WithdrawnISO 7199:2009/Amd 1:2012
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedISO 7199:2016/Amd 1:2020
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00
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Revised by
Under developmentISO 7199
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