BS ISO 15675:2001 pdf – Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters.
1 Scope This International Standard specifies requirements for sterile, single-use, arterial filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans dur- ing cardiopulmonary bypass surgery. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publica- tions do not apply. However, parties to agreements based on this International Standard are encouraged to investi- gate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain reg- isters of currently valid International Standards. 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 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 1 1 : Tests for systemic toxicity ISO 1 1 1 34, Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization ISO 1 1 1 35, Medical devices — Validation and routine control of ethylene oxide sterilization ISO 1 1 1 37, Sterilization of health care products — Requirements for validation and routine control — Radiation ster- ilization ISO 1 1 607, Packaging for terminally sterilized medical devices ISO 1 3485:1 996, Quality systems — Medical devices — Particular requirements for the application of ISO 9001 ISO 1 3488:1 996, Quality systems — Medical devices — Particular requirements for the application of ISO 9002
3 Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 arterial line blood 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 filter containing blood during its intended clinical use 3.3 blood heparinized human or bovine blood, whole or diluted with physiological saline solution 3.4 blood cell damage loss or destruction of cellular components of the blood components 3.5 platelet percentage reduction percentage reduction of platelets contained in a circuit incorporating an arterial line blood filter, less the percentage reduction in an identical control circuit without an arterial line blood filter, as a function of time 3.6 plasma-free haemoglobin generation difference between the concentration of plasma-free haemoglobin in a circuit incorporating an arterial blood filter and the concentration in an identical control circuit without an arterial blood filter, as a function of time 3.7 white blood cell percentage reduction percentage reduction of white blood cells contained in a circuit incorporating an arterial line blood filter, less the percentage reduction in an identical control circuit without an arterial line blood filter, as a function of time 3.8 filtration efficiency ability of the filter to remove particles from the simulated blood suspension test fluid, expressed as a percentage 3.9 blood analogue test solution which simulates blood viscosity 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and nonpyrogenicity The blood pathway shall be sterile and nonpyrogenic. Compliance shall be verified in accordance with 5.2.1 . 4.1.2 Biocompatibility Parts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be verified in accordance with 5.2.2.
4.2 Physical characteristics 4.2.1 Blood pathway integrity When tested in accordance with 5.3.1 , the blood pathway shall not leak. 4.2.2 Blood volume The volume of the blood pathway shall be within the tolerance specified by the manufacturer (see 6.3). 4.2.3 Connectors Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.3, allow a secure connec- tion. Connection for accessory ports shall meet the requirements of ISO 594-2. NOTE Connectors of a type that allows connection of tubes with an inside diameter of , , or , or a type that complies with ISO 71 99, have been found satisfactory. 4.3 Performance characteristics 4.3.1 Blood cell damage When determined in accordance with 5.4.1 , the percentage change (positive or negative) of plasma-free haemoglobin, platelets and white blood cells, shall be within the range of values specified by the manufacturer (see 6.3).