ANSI/AAMI/ISO 18242-2016 pdf download.Cardiovascular implants and extracorporeal systems— Centrifugal blood pumps.
This document specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.
This document does not apply to
— centrifugal pumps used as ventricular assist devices, and
— other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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 1 0993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 1 0993-4, Biological evaluation of medical devices — Part4: Selection of tests for interactions with blood
ISO 1 0993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 1 0993-1 1 , Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 1 1 1 35, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1 1 1 37-1 , Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 1 1 607-1 , Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 1 1 607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming,sealing and assembly processes
ISO 1 1 658, Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 1 7665-1 , 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 18242 pdf download.