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ISO 15674

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/ venous reservoir systems (with/ without filter) and soft venous reservoir bags

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Organization: ISO
Publication Date: 15 August 2016
Status: active
Page Count: 16
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

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 cardiopulmonary bypass (CPB) surgery.

This document applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.

Document History

ISO 15674
February 1, 2020
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/ venous reservoir systems (with/ without filter) and soft venous reservoir bags AMENDMENT 1: Connectors
A description is not available for this item.
ISO 15674
August 15, 2016
Cardiovascular implants and artificial organs - Hard-shell cardiotomy/ venous reservoir systems (with/ without filter) and soft venous reservoir bags
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...
ISO 15674
April 15, 2009
Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
This International Standard specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood...
ISO 15674
November 1, 2001
Cardiovascular Implants and Artificial Organs - Hard-Shell Cardiotomy/Venous Reservoir Systems (With/Without Filter) and Soft Venous Reservoir Bags
A description is not available for this item.

References

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 10993-7 - 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 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 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:
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:
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:
DIN EN ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Published by DIN on December 1, 2017
Dieses Dokument legt allgemeine Anforderungen zur Beurteilung der Wechselwirkungen von Medizinprodukten mit Blut fest. Dieser Teil enthält: a) eine Klassifizierung von für den Kontakt mit Blut...
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