EN 80601-2-61
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DIN EN 80601-2-61 |
|---|---|
| Area | Medical technology |
| title | Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximetry equipment |
| Latest edition | 2012-01 |
| ISO | IEC 62D / 718 / CD: 2008 |
The EN 80601-2-61 with the title "Medical electrical equipment - Part 2-61: Special requirements for the safety including the essential performance characteristics of pulse oximetry equipment" is part of the EN 60601 series of standards (the EN-60601 series is currently being incorporated into EN -80601 series transferred).
The DIN standard DIN EN 80601-2-61 is published by the German Institute for Standardization .
The standard is based on the international version IEC IEC 62D / 718 / CD: 2008. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-61 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for the safety, tests and guidelines of pulse oximetry devices. The purpose is to describe the features of basic safety, the essential performance features and tests and also to provide instructions for their application.
validity
- The final version of the standard is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
scope of application
This International Standard specifies particular requirements for the basic safety and essential performance characteristics of pulse oximetry devices intended for human use; they are hereinafter referred to as ME devices. This includes all parts that are required for the intended use; this includes the pulse oximetry monitor, the pulse oximetry sensor, and the sensor extension cable.
These requirements also apply to pulse oximetry devices, including pulse oximetry monitors, pulse oximetry sensors, and sensor extension cables that have been refurbished.
The intended use of pulse oximetry equipment includes, but is not limited to, the estimation of arterial oxygen hemoglobin saturation and pulse rate in patients inside and outside the hospital, including use in the home environment. These special requirements do not apply to pulse oximetry devices intended for use in laboratory research applications or to oximeters that require a blood sample from the patient.
Hazards resulting from the intended physiological mode of action of ME devices or ME systems in the scope of this standard are not covered by special requirements in this standard.
This standard can also be applied to pulse oximetry devices and their accessories which are used for the compensation or relief of illness, injury or disability. This standard does not apply to remotely located or coupled (secondary) devices that display SpO2 values and that are located outside the patient environment.
extra information
- This standard is new and has no previous standard.
- It is intended to replace EN ISO 9919 (VDE 0750-54): 2005-09
The following changed requirements are contained in EN 80601-2-61 (extract):
- Protection against excessive temperatures
- Protection against ingress of water
- Interruption of the power supply
- Alarms
- accuracy
- Structure (shock, vibration)
- Electromagnetic compatibility
- Reference to the application of ( EN 60601-1-2 , EN 60601-1-6 , EN 60601-1-8 , EN 60601-1-9 , EN 60601-1-10 , EN 60601-1-11 )