ISO 11658:2012
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

Standard No.

ISO 11658:2012

Release Date

2012

Published By

International Organization for Standardization (ISO)

Latest

ISO 11658:2012

Scope

This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device. The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.

ISO 11658:2012 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• 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
• ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 15674 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors*， 2020-02-17 Update
• ISO 15675 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors*， 2020-02-17 Update
• ISO 15676 Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)*， 2016-08-01 Update
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 7199 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Connectors*， 2020-03-16 Update

ISO 11658:2012 history

• 2012 ISO 11658:2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems