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DIN EN ISO 7199

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020) (includes Amendment :2020)

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Organization: DIN
Publication Date: 1 October 2020
Status: active
Page Count: 39
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

DIN EN ISO 7199
August 1, 2023
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023); German and English version prEN ISO 7199:2023
A description is not available for this item.
DIN EN ISO 7199
October 1, 2020
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020) (includes Amendment :2020)
A description is not available for this item.
DIN EN ISO 7199/A1
September 1, 2018
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/DAM 1:2018); German and English version EN ISO 7199:2017/prA1:2018
A description is not available for this item.
DIN EN ISO 7199
May 1, 2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
This document 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...
DIN EN ISO 7199
June 1, 2015
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2015); German and English version prEN ISO 7199:2015
A description is not available for this item.
DIN EN ISO 7199
November 1, 2014
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 removal of carbon dioxide from, the...
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References

This document references:
ISO 15675 - Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters AMENDMENT 1: Connectors
Published by ISO on February 1, 2020
A description is not available for this item.
This document references:
ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
This document references:
ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Published by ISO on April 1, 2017
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
This document references:
ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on July 15, 2014
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial...
This document references:
ISO 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
This document references:
ISO 17665-1 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2006
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this...
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