Standard

ISO 7199:2016

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Note: This standard has a new edition: ISO 7199:2024

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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.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 3
  • Version: 1
  • Document type: IS
  • ICS 11.040.40
  • ISO TC ISO/TC 150/SC 2

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