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. Clauses 201.12.1.107, 201.15.3.5.101, 201.15.3.5.102, 201.104, 201.105.3, 201.105.3.2, and 211.8.3.1 are conflict with an established guideline, see section 10 of the 2017 ACC/AHA Guideline listed below.