AAMI AT6 pdf free download

AAMI AT6 pdf free download.Autologous transfusion devices.
2.5 INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC). Industrial, scientific, and medical (ISM) radio- frequency equipment—Electromagnetic disturbance characteristics—Limits and methods of measurement, IEC CISPR 11. Geneva: IEC.
2.6 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Biological evaluation of medical devices—Part
1: Evaluation and testing, ISO 10993-1. Geneva: ISO.
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2.8 U.S. FOOD AND DRUG ADMINSTRATION/CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.
Guideline on validation of the limulus amebocyte lysate test as an end-product endo toxin test for human and animal parenteral drugs, biological products, and medical devices. Rockville (MD): FDA/CDRH, December 1997.
2.9 U.S. PHARMACOPEIAL CONVENTION. Pyrogeri Test USP27 <151>, Rockville (MD): U.S. Pharmacopeial Convention Inc.
3 Definitions
For the purposes of this standard, the following definitions apply:
3.1 accuracy: Ratio of the error (measured minus true) to the true or theoretical value, expressed as a percentage.
3.2 anticoagulation: Process of adding to and mixing collected blood with a substance that hinders clotting in a
volume commensurate with the volume of the container and the rate of blood collection.
3.3 aspiration flow: Movement of blood from the donor into the autologous transfusion device occasioned by the
negative pressure developed by a pump suction.
3.4 autologous transfusion (AT): Harvest, storage, and reinfusion of the blood products of the same patient.
3.5 cell recovery: Relative number of cells remaining after the AT process, as compared to the number of cells entering the AT process.
3.6 collection: Process of removing donor blood into a container or device.
3.7 component: One of any number of discrete parts that make up the entire device.
3.8 dwell time: Period of time the blood remains in the device before it is reinfused; the time the blood is in contact
with the device from beginning to end excluding the length of time that the blood is stored in a transfer bag.
3.9 fiber: Particle longer than 100 .m with a length-to-width ratio of greater than 10:1, regardless of composition.
3.10 fluid pathway: Portion of the device that in normal use comes into contact with blood or other liquids used in the process.
3.11 hematocrit (hct): Percentage of a volume of blood that is composed of red blood cells.
3.12 inspection: Examination (e.g., visual, auditory) and/or investigation without the use of special laboratory
appliances or procedures.
3.13 manufacturer: Vendor whose name appears on the label of the device and bears the responsibilities addressed to the “manufacturer” in this standard; may be either the company that makes the device or the distributor that distributes the device.
4.1.2 Disposable blood contact components Because of the nature of these components, labeling information is not required on the device itself but may instead be included on the outer wrap of the package containing the disposable component or as a package insert. This information shall include the following: a) Component name, part number (if applicable), manufacturer, lot number, sterility and pyrogenicity statement, method of sterilization, sterility expiration date, and other information deemed appropriate for intended use. b) Diagrammatic or other instructions needed for proper setup and use. AAMI AT6 pdf download.