Standard Number: YY 1139-2013(YY1139-2013)
Chinese:心电诊断设备
English:Diagnostic electrocardiographic devices
Effective Date:2014-10-01
ICS:11.040.50
Standard Applicability:This standard establishes minimum performance requirements for electrocardiographic diagnostic equipment (hereinafter or referred to as equipment), as defined in 3.9, which has a direct recording device. All parts of the electrocardiographic diagnostic equipment are applicable to this standard, and they shall consist of obtaining an electrocardiographic signal from the surface of the human body, amplifying that signal, and displaying the model in a manner suitable for diagnosing the electrical activity of the heart. This standard specifies requirements for electrocardiographic diagnostic equipment from the input electrode to the output display. This standard applies to the following equipment: a) electrocardiographs for direct recording; b) electrocardiographs used in other medical devices (e.g., patient monitors, defibrillators, and stress-testing equipment), as long as these devices have electrocardiographic diagnostic capabilities; and c) electrocardiographs capable of displaying patient signals remotely, which are via cables, telephones, telemetry, or storage media, as long as these devices have electrocardiographic diagnostic capabilities. These devices comply with the performance requirements of the functional aspects of the output-input relationship of the overall system.
PDF Downloadable: Y
You can click the button below to purchase the PDF version, and we will send it to you via email.Click below to buy the printed version. Shipped via FedEx within 7 days. Full refund if out of stock.
If you encounter the following issues, please click here to contact us, and we will do our best to assist you.
1. You cannot find the standard document you are looking for on our website.
2. You have found the standard document, but our page indicates that PDF download is not available.
3. You need to purchase our translated version.
