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BSI - BS ISO 7199

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

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Organization: BSI
Publication Date: 30 November 2009
Status: inactive
Page Count: 22
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

23/30440702 DC
July 24, 2023
Draft BS EN ISO 7199 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
A description is not available for this item.
BS EN ISO 7199
January 31, 2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
A description is not available for this item.
BS EN ISO 7199
January 31, 2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
A description is not available for this item.
BS ISO 7199
November 30, 2009
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
A description is not available for this item.
BS ISO 7199
November 30, 2009
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
A description is not available for this item.
BS EN ISO 7199
November 30, 2009
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 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 TS 23810 - Cardiovascular implants and artificial organs - Checklists for use of extracorporeal circulation equipment
Published by ISO on July 1, 2018
This document covers the activities performed by perfusionists before, during, and after extracorporeal circulation. Clause 4 covers the perfusionists’ actions during preoperative extracorporeal...
This document references:
11607-1 AMD 1 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1: Application of risk management
Published by ISO on September 1, 2023
A description is not available for this item.
This document references:
ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Published by ISO on February 1, 2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
This document is referenced by:
BS EN ISO 10993-4 - Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
Published by BSI on May 31, 2017
A description is not available for this item.
This document is referenced by:
BS ISO 11658 - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Published by BSI on May 31, 2012
A description is not available for this item.
This document is referenced by:
BS ISO 15674 - Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
Published by BSI on August 31, 2016
A description is not available for this item.
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