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Norm

ÖNORM EN ISO 7199

Issue date: 2014 12 01

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)

This International Standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and remova...
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Withdrawn : 2017 04 01
Publisher:
Austrian Standards International
Format:
Digital | 17 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This International Standard 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. This International Standard also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device. This International Standard does not apply to: - implanted oxygenators; - liquid oxygenators; - extracorporeal circuits (blood tubing); - separate heat exchangers; - separate ancillary devices.
ÖNORM EN ISO 7199
2020 10 01
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ÖNORM EN ISO 7199
2017 04 01
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ÖNORM EN ISO 7199
2014 12 01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + ...
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ÖNORM EN 12022
1999 06 01
Blood gas exchangers
Norm
Historie aufklappen
Norm
ISO 10993-1:2009
Issue date : 2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
ISO 10993-7:2008
Issue date : 2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
ISO 10993-11:2006
Issue date : 2006 08 15
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
ISO 11137-1:2006
Issue date : 2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11607-1:2006
Issue date : 2006 04 07
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Norm
ISO 11607-2:2006
Issue date : 2006 04 07
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Norm
ISO 17665-1:2006
Issue date : 2006 08 17
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 10993-7:2008
Issue date : 2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
ISO 10993-11:2017
Issue date : 2017 09 14
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
ISO 11135:1994
Issue date : 1994 01 27
Medical devices — Validation and routine control of ethylene oxide sterilization
Norm
ISO 11137-1:2006
Issue date : 2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11607-1:2019
Issue date : 2019 01 31
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Norm
ISO 11607-2:2019
Issue date : 2019 01 31
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Norm
ISO 17665-1:2006
Issue date : 2006 08 17
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ÖNORM EN ISO 7199
Issue date : 2017 04 01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Norm
ISO 7199:2009
Issue date : 2009 03 30
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)