Pulse Oximeter Certification and Testing Standards

Working Principle of Pulse Oximeters:

- Measurement of pulse oxygen saturation (SpO₂) typically employs photoelectric technology, using either transmission or reflection methods.

- "Ired" represents infrared light; "Red" represents red light.

- The AC/DC ratios of infrared and red light are calculated to obtain an R-value.

- Using the R-value lookup table (calibrated through blood gas experiments), the blood oxygen saturation is determined.

Common Product Standards:

Domestic (China):

- EMC Standards:

- YY 9706.102 - 2021

- GB 9706.1 - 2020

- Electrical Safety Standards:

- YY 9706.111 - 2021

- YY 9706.108 - 2021 (if applicable)

- GB/T 14710 - 2009

- Performance Standards:

- YY 9706.261 - 2023

- Product Technical Requirement Document

- Biocompatibility Standards:

- GB/T 16886.5 - 2017

- GB/T 16886.10 - 2017

- GB/T 16886.11 - 2021

- Cleaning, Disinfection, Sterilization Standards:

- WS 310.3 - 2016

- WS/T 367 - 2012

- YY/T 0734.1 - 2018

- YY/T 0734.5 - 2020

International:

- EMC Standards:

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

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

- Electrical Safety Standards:

- 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 Standards:

- ISO 80601-2-61:2017

- EN ISO 80601-2-61:2019

- Biocompatibility Standards:

- 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 Standards:

- AAMI TIR 12 - 2020

- AAMI ST98 - 2022

- ISO 15883-5:2021

- ISO 15883-6:2011

Note:

Certification and testing services are provided by JJR Laboratory in China.