ANSI EC12-2000 pdf download The Objectives and Uses of AAMI Standards and Recommended Practices
4.3 Safety requirements
4.3.1 Biological response The device shall be biocompatible. For this application (i.e., an electrode in contact with the skin) biocompatibility requires evaluation of cytotoxicity, skin irritation, and either skin sensitization or intracutaneous reactivity.
4.3.2 Pre-attached leadwire safety Electrodes with pre-attached (permanently attached) leadwires shall be constructed in such a manner that the leadwire connector used to mate with the instrument trunk cable cannot contact ground or a possibly hazardous potential. In particular, this connector shall be constructed to prevent conductive contact with a mains outlet or a detachable power cord. NOTE—ANSI/AAMI EC53:1 995, ECG cables and leadwires, should be reviewed and considered in the process of designing and manufacturing ECG electrodes with pre-attached leadwires.
4.4 Adhesive performance (duration of use) The electrode’s adhesive performance, as it impacts the duration of use, should meet the claims or applications that the manufacturer has indicated. For example, for a short-term, resting electrocardiogram, an adhesive should be able to maintain its contact to the body for a period of time normally associated with this procedure; a projection would be from 5 min to 30 min. Long-term monitoring, on the other hand, may require the electrode to be on the patient for a period of days, depending upon hospital protocol. Therefore, an adhesive that is to be utilized in an ECG electrode should have performance characteristics that meet the intended use of the device.
5 Tests This section contains test methods that provide means of verifying the performance and safety of disposable ECG electrodes. These test methods and procedures are intended as referee tests in determining compliance with the requirements of 4; while they may be used for design qualification, they are not necessarily suitable for purposes of quality assurance. The paragraphs of this section are numbered, with the exception of the first digit, to correspond to the requirements of 4; for example, compliance with 4.2.2.1 can be determined by the test method of 5.2.2.1 . NOTES— 1 ) Unless otherwise specified in 4, it is not necessarily intended that the same electrode pairs be used for the full series of tests. Also, unless the number of electrode pairs to be tested is specified in section 4, “n” electrode pairs in the tests means the number needed to establish, statistically, that the performance of the electrode pairs tested is representative of the product type. 2) For non-pregelled electrodes, tests shall be conducted with electrolyte applied in accordance with manufacturer’s instructions.
5.1 Labeling Compliance with the requirements of 4.1 a), 4.1 c), and 4.1 d) can be determined by inspection. For 4.1 b), if an outof-pouch shelf life is indicated, the tests of 5.2.2 shall be applied to verify that acceptable performance is maintained for the period indicated by the manufacturer.
5.2 Performance
5.2.1 Packaging and shelf life The tests of 5.2.2 can be used to determine whether the packaging is adequate to preserve the performance characteristics of the electrode over the shelf life specified by the manufacturer.