YY 0784-2010
Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use (English Version)
- Standard No.
- YY 0784-2010
- Language
- Chinese, Available in English version
- Release Date
- 2010
- Published By
- Professional Standard - Medicine
- Status
- 2026-01
- Replace By
- YY 9706.261-2023
- Latest
- YY 9706.261-2023
- Scope
- Quoting Chapter 1 of GB 9706.1-2007, excluding the following content. Modification (added at the end of 1.1) This standard describes in detail the specific requirements for the basic safety and main performance of pulse oximeter equipment for human use, including any necessary parts for normal use, such as pulse oximeter Monitors, pulse oximeter probes, probe cable extensions, etc. These requirements also apply to reprocessed pulse oximeter equipment, including pulse oximeter monitors, blood oxygen probes and probe cable extensions. Applications for pulse oximeter devices include, but are not limited to, estimating a patient's arterial oxygen saturation and pulse rate in healthcare settings and at home. This standard does not apply to pulse oximeter equipment used in laboratory research, nor to oximeters that require the collection of patient blood samples. This standard does not apply to fetal pulse oximeter equipment. This standard does not apply to telemetry or master (slave) devices that display SpO values placed outside the patient environment. The requirements of this standard replace or modify GB 9706.1-2007, and are expected to take precedence over the corresponding general requirements.
YY 0784-2010 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 0784-2010 Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use was changed to YY 9706.261-2023 Medical electrical equipment Part 2-61: Specific requirements for basic safety and basic performance of pulse oximetry equipment.
