Standard Number: YY 9706.261-2023(YY9706.261-2023)
Chinese:医用电气设备 第2-61部分:脉搏血氧设备的基本安全和基本性能专用要求
English:Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Effective Date:2026-01-15
ICS:11.040.10
Standard Applicability:This document establishes the basic safety and basic 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 oximetry monitors, pulse oximetry probes, and cable extensions for the probes. This document applies to, but is not limited to, pulse oximetry devices that are expected to estimate a patient’s arterial oxygen saturation and pulse rate in specialized healthcare facilities, home care settings, and emergency medical services settings. This document also applies to pulse oximetry devices for the compensation or relief of disease, injury, or disability, and to pulse oximetry devices expected to be used in extreme or uncontrolled environments outside the hospital or physician’s office, e.g., ambulance and air transfer, and the supplemental standard applies to pulse oximetry devices for use in these environments. This document does not apply to pulse oximetry equipment used for laboratory research or to oximeters that require the collection of blood samples from patients. This document does not apply to fetal-specific pulse oximetry equipment. This document does not apply to remote or slave (secondary) devices that are placed outside the patient environment to display SpO2 values.
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