YY 9706.261-2023
Medical electrical equipment Part 2-61: Specific requirements for basic safety and basic performance of pulse oximetry equipment (English Version)
- Standard No.
- YY 9706.261-2023
- Language
- Chinese, Available in English version
- Release Date
- 2023
- Published By
- 国家药监局
- Latest
- YY 9706.261-2023
- Replace
- YY 0784-2010
- Scope
- This document specifies the basic safety and essential performance of pulse oximetry equipment. This document applies to pulse oximetry equipment for human use and reprocessed pulse oximetry equipment. Pulse oximetry equipment includes pulse oximeter monitors, pulse oximeter probes, and probe cable extensions. This document applies to, but is not limited to, pulse oximetry devices intended for use in estimating arterial oxygen saturation and pulse rate of patients in professional healthcare facilities, home care settings, and emergency medical services settings. This document also applies to pulse oximetry devices used to compensate for or alleviate disease, injury, or disability, and to pulse oximetry devices intended for use outside hospitals or physician offices in extreme or uncontrolled environments, such as ambulances and aviation Transport, supplementary standards apply to pulse oximetry devices used in these settings. This document does not apply to pulse oximeter equipment used in laboratory research or to oximeters that require the collection of patient blood samples. This document does not apply to fetal-specific pulse oximetry equipment. This document does not apply to remote or slave (secondary) devices that display SpO2 values placed outside the patient environment.
YY 9706.261-2023 history
- 2023 YY 9706.261-2023 Medical electrical equipment Part 2-61: Specific requirements for basic safety and basic performance of pulse oximetry equipment
- 2010 YY 0784-2010 Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use
YY 9706.261-2023 Medical electrical equipment Part 2-61: Specific requirements for basic safety and basic performance of pulse oximetry equipment has been changed from YY 0784-2010 Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use.
