YY 0670-2008 (English Version) PDF

Scope: This standard specifies the requirements for the safety and effectiveness of all automatic, electronic arterial sphygmomanometers that use an occlusion cuff to measure indirect arterial blood pressure in humans. This standard applies to electronic sphygmomanometers or other devices with this function that use oscillometric methods or other similar methods to complete non-invasive blood pressure measurements. Including all instruments that inflate and deflate the cuff, and use the generated vibration, flow, and sound to measure, display, and record blood pressure. This standard covers all blood pressure measurement devices for all ages, from newborns to adults. This standard also applies to ambulatory blood pressure monitors. Patients with such devices can wear or carry them with them, and can repeatedly measure blood pressure and heart rate during daily activities or daily life, and save the results obtained. This standard does not apply to devices for direct, arterial invasive blood pressure measurement. This standard does not apply to automatic blood pressure monitors that measure blood pressure through finger, chest impedance and other methods.

YY 0670-2008 Referenced Document

GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY 0667-2008 Medical electrical equipment—Part 2-30:Particular requirements for the safety,including essential performance,of automatic cycling non-invasive blood pressure monitoring equipment

2023 YY 9706.230-2023 Medical electrical equipment Part 2-30: Specific requirements for basic safety and basic performance of automatic non-invasive blood pressure monitors
2008 YY 0670-2008 Non-invasive automated sphygmomanometer