BS ISO 15676:2016 pdf free

BS ISO 15676:2016 pdf free.Cardiovascular implants and artificial organs
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 34-1, Rubber, vulcanized or thermoplastic一Determination of tear strength一Part 1: Trouser, angle and crescent test pieces
ISO 527-1, Plastics一Determination of tensile properties一Part 1: General principles
ISO 9352, Plastics一Determination of resistance to wear by abrasive wheels
ISO 10993-1, Biological evaluation of medical devices一Part 1: Evaluation and testing within a risk management process
ISO 10993-7, Biological evaluation of medical devices一Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices一Part 11: Tests for systemic toxicity
ISO 17665-1, Sterilization of health care products一Moist heat一Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices
ISO 11135, Sterilization of health-care products一Ethylene oxide 一Requirements for the development,validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products一Radiation 一Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products一Radiation一Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices一Part 1: Requirements for materials,sterile barrier systems and packaging systems
The manufacturer shall conduct the test with a conventional dual-roller pump, reservoir,tubing, measurement and control equipment specified by the manufacturer. Tubing of each internal diameter and wall thickness shall be tested. The operating variables of pump speed, back pressure, liquid temperature, and method of setting pump occlusion shall be described, monitored and kept constant over the course of the test.
The test liquid shall be glycerine solution to simulate blood viscosity and the test shall be conducted at temperatures intended for clinical use, pre-filtered through a 5 um filter.
The minimum volume of fluid in the circuit shall be provided and actual volume contained at test onset shall be reported.
The flow rate(s) shall be reported, so that the volume/hour of fluid contacting the tubing wall can be estimated, as in accepted methods for quantifying wear debris generation.
The filter should be removed at the appropriate time point (e.g. 1 h, 2 h, or longer depending on specific application such as CPB or ECMO as described in 5.4.2.7) assuring that all the liquid contained in the circuit has passed through the filter at least once and a new filter inserted for the next time period.BS ISO 15676 pdf download.