ECG Device Certification Testing

Product Principle:

The dynaMIC electrocardiogram (ECG) system captures the heart’s electrical activity through electrodes placed on the patient's body surface, recording potential differences between measurement points to obtain ECG signals. The dynamic ECG analysis software replays, analyzes, classifies, and statistically processes the ECG data.

Domestic / International Standards:

- China:

- EMC: YY 9706.102 - 2021

- Safety: GB 9706.1 - 2020, YY 9706.111 - 2021, GB/T 14710 - 2009

- Performance: YY 9706.247 - 2021

- biocompatibility: GB/T 16886.5 - 2017, GB/T 16886.10 - 2017, GB/T 16886.11 - 2021

- Cleaning, Disinfection, and Sterilization: WS 310.3 - 2016, WS/T 367 - 2012, YY/T 0734.1 - 2018, YY/T 0734.5 - 2020

- International:

- 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

- Performance: IEC 60601-2-47:2012, EN 60601-2-47:2015

- 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, and Sterilization: AAMI TIR 12 - 2020, AAMI ST98 - 2022, ISO 15883-5:2021, ISO 15883-6:2011

JJR Laboratory in China provides ECG deviCE certification testing services.