1Key Takeaways
This document specifies requirements for sterile, single-use extracorporeal blood gas exchangers (oxygenators) intended for supplying oxygen to and removing carbon dioxide from human blood. This document also applies to heat exchangers and arterial filters integrated into oxygenators. This document also applies to exte…
2Scope / Description
This document specifies requirements for sterile, single-use extracorporeal blood gas exchangers (oxygenators) intended for supplying oxygen to and removing carbon dioxide from human blood. This document also applies to heat exchangers and arterial filters integrated into oxygenators. This document also applies to external devices intended solely for use with the oxygenator. Excluded are: implanted oxygenators; liquid oxygenators; extracorporeal circuits (blood tubing systems); separate heat exchangers; separate auxiliary devices; and separate arterial filter lines.
3Version History
DIN EN ISO 7199:1970
older
1970-01
5Citation Network
Referenced by DIN EN ISO 7199:2020
ISO 10993-1
ISO 10993-11
ISO 10993-4
ISO 10993-7
ISO 11135
ISO 11137-1
ISO 11607-1
ISO 11607-2
6Frequently Asked Questions
What is DIN EN ISO 7199:2020?
DIN EN ISO 7199:2020 — Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020) (includes Amendment :2020) is an international standard developed by German Institute for Standardization. This document specifies requirements for sterile, single-use extracorporeal blood gas exchangers (oxygenators) intended for supplying oxygen to and removing carbon dioxide from human blood. This document also applies to heat exchangers and arterial...
What does DIN EN ISO 7199:2020 cover?
This standard covers: This document specifies requirements for sterile, single-use extracorporeal blood gas exchangers (oxygenators) intended for supplying oxygen to and removing carbon dioxide from human blood. This document also applies to heat exchangers and arterial filters integrated into oxygenators. This document...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of DIN EN ISO 7199:2020?
The current published version is DIN EN ISO 7199:2020, published on 2020-10-01. Always check for amendments or pending revisions.
How do I purchase DIN EN ISO 7199:2020?
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