DANSK DSF/FPREN 80601-2-30 PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 208 AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of 209 an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE 210 without arterial puncture. 211 NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does 212 not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. 213 This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for 214 this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a 215 DETERMINATION. 216 This standard covers electrically-powered intermittent, indirect measurement of the BLOOD 217 PRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimating 218 BLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture 220 ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in 221 conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE 222 (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1. [1]2) 223 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to 224 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the 225 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 226 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS 227 within the scope of this standard are not covered by specific requirements in this standard 228 except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1. 229 NOTE 2 See also 4.2 of the general standard.