Abstract
PreviewISO 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.
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Status: PublishedPublication date: 2016-11
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Edition: 3Number of pages: 13
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- ICS :
- 11.040.40 Implants for surgery, prosthetics and orthotics
Buy this standard
Format | Language | |
---|---|---|
std 1 92 | PDF + ePub | |
std 2 92 | Paper |
- CHF92
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
Corrigenda / Amendments
PublishedISO 7199:2016/Amd 1:2020
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00
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Will be replaced by
Under developmentISO/DIS 7199
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