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ISO 7199

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

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Organization: ISO
Publication Date: 15 November 2016
Status: active
Page Count: 20
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

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 humans.

This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

This document also applies to external equipment unique to the use of the oxygenator.

This document does not apply to

- implanted oxygenators,

- liquid oxygenators,

- extracorporeal circuits (blood tubing),

- separate heat exchangers,

- separate ancillary devices, and

- separate arterial line filter.

Document History

DIS 7199
July 19, 2023
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
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, human blood,...
ISO 7199
March 1, 2020
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) AMENDMENT 1: Connectors
A description is not available for this item.
ISO 7199
November 15, 2016
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
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...
ISO 7199
February 15, 2012
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) AMENDMENT 1: Clarifications for test methodologies, labelling, and sampling schedule
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...
ISO 7199
April 15, 2009
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
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...
ISO 7199
December 15, 1996
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
A description is not available for this item.
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References

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 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Published by ISO on September 1, 2017
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
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 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 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 is referenced by:
AAMI 15674 - Cardiovascular implants and artificial organs - Hard-shell cardiotomy/ venous reservoir systems (with/without filter) and soft venous reservoir bags
Published by AAMI on September 2, 2016
This document specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during...
This document is referenced by:
AAMI 15675 - Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial blood line filters
Published by AAMI on September 2, 2016
This document specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous...
This document is referenced by:
EN ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Published by CEN on May 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 is referenced by:
TR 12417-2 - Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Published by ISO on July 1, 2022
This document provides region-specific information for: — local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world; — changes...
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