This International Standard applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for intermittent indirect measurement of the blood pressure without arterial puncture.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Section 202.6.2.3.1 is in conflict with another recognized standard, see Table 4 in IEC 60601-1-2 listed below. Section 201.7.9.2.13 is in conflict with a test method and/or specification that is not scientifically acceptable, see article listed below.