ANSI/AAMI/ISO 7199:2016 pdf download.Cardiovascular implants and artifcial organs—Blood-gas exchangers (oxygenators).
This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
This document also applies to heat exchangers and arterial fiters that are integral parts of the oxygenator.
This document also applies to external equipment unique to the use of the oxygenator.
This document does not apply to implanted oxygenators,
liquid oxygenators,
extracorporeal circuits (blood tubing),
separate heat exchangers,
separate ancillary devices, and
separate arterial line fiter.
Normative references
The fllowing 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 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood
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, Stenlization of health-care products - Ethylene oxide - Requirements for the 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 11607-1, Packaging for terminally stenilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 15675, Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems一Arterial blood line filters
ISo 17665-1, Sternlization of health care products 一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 fllowing terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the fllowing addresses:
-IEC Electropedia: available at ht:/ww.electropedia.org/
-ISO Online browsing platform: available at htt/www.iso.org/o
3.1 blood-gas exchanger
oxygenator extracorporeal device designed to supplement, or be a substitute for, the respiratory function of the lungs
3.2 blood pathway
paths of the oxygenator containing blood during intended clinical use
3.3 gas pathway
parts of the oxygenator containing the ventilation gas during intended clinical use
3.4 heat exchanger
component that is intended to control the temperature of the circulating blood or priming solution
3.5 heat exchanger performance factor
R ratio of the difference between the temperature of blood at the outlet of the oxygenator and the temperature of blood at the inlet of the oxygenator to the difterence between the temperature of the water at the inlet of the heat exchanger and the temperature of blood at the inlet of the oxygenator