Blood Pressure Monitor Certification Testing Services

Working Principle of Blood Pressure Monitor:

The wrist-type electronic blood pressure monitor measures the diastolic pressure, systolic pressure, and pulse rate of the human body, with the values provided for diagnostic reference. The electronic blood pressure monitor that uses the oscillometric method to measure blood pressure can be classified into two types based on the measurement method: the deflation measurement and inflation measurement.

Common Product Standards:

- Domestic Standards:

- EMC: YY 9706.102 - 2021

- Safety:

- GB 9706.1 - 2020

- YY 9706.111 - 2021

- YY 9706.108 - 2021 (if applicable)

- GB/T 14710 - 2009

- Performance: YY 9706.230 - 2023

- Product Technical Requirements Document

- Biocompatibility:

- GB/T 16886.5 - 2017

- GB/T 16886.10 - 2017

- GB/T 16886.11 - 2021

- Cleaning, Disinfection, Sterilization:

- WS 310.1 - 2016

- WS 310.2 - 2016

- WS/T 367 - 2012

- GB 18278.1 - 2015

- International Standards:

- EMC:

- IEC 60601 - 1 - 2:2014/AMD1:2020

- EN 60601 - 1 - 2:2015/A1:2021

- Safety:

- IEC 60601 - 1:2005/AMD2:2020

- EN 60601 - 1:2006/A2:2021

- IEC 60601 - 1 - 11:2015/AMD1:2020

- EN 60601 - 1 - 11:2015/A1:2021

- IEC 60601 - 1 - 8:2006/AMD2:2020 (if applicable)

- EN 60601 - 1 - 8:2007/A2:2021 (if applicable)

- Performance:

- IEC 80601 - 2 - 30:2018

- EN IEC 80601 - 2 - 30:2019

- Biocompatibility:

- ISO 10993 - 5: 2009

- EN ISO 10993 - 5: 2009

- ISO 10993 - 10:2021

- EN ISO 10993 - 10:2023

- ISO 10993 - 23: 2021

- EN ISO 10993 - 23:2021

- ISO 10993 - 11:2017

- EN ISO 10993 - 11:2018

- Cleaning, Disinfection, Sterilization:

- AAMI TIR 12 - 2020

- AAMI ST98 - 2022

- ISO 15883 - 5: 2021

- ISO 15883 - 6: 2011

JJR Laboratory in China offers certification testing services.