ISO/DIS 7199
u
ISO/DIS 7199
83184

Status : Under development

en
Format Language
std 1 63 PDF
std 2 63 Paper
  • CHF63
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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.

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General information

  •  : Under development
    : Full report circulated: DIS approved for registration as FDIS [40.99]
  •  : 4
     : 14
  • ISO/TC 150/SC 2
    11.040.40 
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