UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ISO 15675

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters

active, Most Current
Buy Now
Organization: ISO
Publication Date: 15 August 2016
Status: active
Page Count: 14
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

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 material from the blood of humans during cardiopulmonary bypass surgery.

Document History

ISO 15675
February 1, 2020
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters AMENDMENT 1: Connectors
A description is not available for this item.
ISO 15675
August 15, 2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
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...
ISO 15675
April 15, 2009
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
This International Standard specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid...
ISO 15675
October 1, 2001
Cardiovascular Implants and Artificial Organs - Cardiopulmonary Bypass Systems - Arterial Line Blood Filters
A description is not available for this item.

References

This document references:
ISO 7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Published by ISO on November 15, 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...
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:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
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 7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Published by ISO on November 15, 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...
This document is referenced by:
EN ISO 7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors
Published by CEN on January 1, 2017
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...
This document is referenced by:
DIN EN ISO 7199 - Kardiovaskulaere Implantate und kuenstliche Organe - Blut-Gas-Austauscher (Oxygenatoren) (ISO 7199:2016 + Amd 1:2020); Deutsche Fassung EN ISO 7199:2017 + A1:2020
Published by DIN on October 1, 2020
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.
View Less
View All
Advertisement