ANSI/AAMI/ISO 11658-2012 pdf download.Cardiovascular implants and extracorporeal systems — Blood/ tissue contact surface modifcations for extracorporeal perfusion systems.
This International Standard specifes requirements for the physical, biological and performance testing of biocompatible modifcations 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 modifcations 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7199, Cardiovascular implants and artifcial organs — Blood-gas exchangers (oxygenators)
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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
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 artifcial organs — Hard-shell cardiotomy/venous reservoir systems (with/without flter) and soft venous reservoir bags
ISO 15675, Cardiovascular implants and artifcial organs — Cardiopulmonary bypass systems — Arterial blood line flters
ISO 15676, Cardiovascular implants and artifcial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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.ANSI/AAMI/ISO 11658 pdf download.