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ISO 15675

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

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Organization: ISO
Publication Date: 15 April 2009
Status: inactive
Page Count: 14
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

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 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 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 10993-7 - 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 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 is referenced by:
ISO 11658 - Cardiovascular implants and extracorporeal systems - Blood/ tissue contact surface modifications for extracorporeal perfusion systems
Published by ISO on May 15, 2012
This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is...
This document is referenced by:
AAMI 11658 - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Published by AAMI on January 1, 2012
This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is...
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