ISO 15675-16-2016 pdf free.Cardiovascular implants and artificial organs – Cardiopulmonary bypass systems – Arterial blood line filters. 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 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, Sterilization of health-care products — Ethylene oxide — Requirements…

ISO 7199-2016 pdf free.Cardiovascular implants and artificial organs一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 filters 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 filter. 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 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 150 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals ISO…