International Standard
ISO 7199:2016
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Reference number
ISO 7199:2016
Edition 3
2016-11
© ISO 2024
International Standard
Read sample
Published (Edition 3, 2016)
This standard has 1 amendment.

ISO 7199:2016

Format
Language
CHF 96
Convert Swiss francs (CHF) to your currency

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

  • Status
     : Published
    Publication date
     : 2016-11
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 3
    Number of pages
     : 13
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS updates

 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.

Amendment 1

Connectors

Edition 2020

Format
Language
CHF 18
Convert Swiss francs (CHF) to your currency

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO 7199:2016