ANSI/AAMI/ISO 15675-2016 pdf download.Cardiovascular implants and artifcial organs— Cardiopulmonary bypass systems—Arterial blood line flters.
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 material from the blood of humans during cardiopulmonary bypass surgery.
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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
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 — Part 4: Selection of tests for interaction 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 4937, 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 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1 arterial blood line filter
accessory device used as part of the cardiopulmonary bypass system in the arterial blood return line for filtering particles such as blood clots, debris and gas emboli from the blood
3.2 blood pathway
paths of the arterial blood line filter (3.1 ) containing blood during its intended clinical use
3.3 blood cell damage
loss or destruction of cellular components of the blood components
3.4 platelet reduction
percentage reduction of platelets contained in a circuit, as a function of time
3.5 plasma-free haemoglobin level
difference between the concentration of plasma-free haemoglobin in a circuit, as a function of time.ANSI/AAMI/ISO 15675 pdf download.