What is ISO 80601‑2‑85 about?
ISO 80601 series discusses standards for medical electrical equipment. ISO 80601‑2‑85 guides you about safety and performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head.
ISO 80601‑2‑85 applies to medical electrical (ME) equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.
ISO 80601‑2‑85 also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes, and probe cable extenders, that have been remanufactured.
ISO 80601‑2‑85 also applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.
Note: ISO 80601‑2‑85 is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment.
Note: Cerebral tissue oximeters are sometimes referred to as near-infrared spectroscopy equipment in the medical literature.
Note: ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
Who is ISO 80601‑2‑85 for?
ISO 80601‑2‑85 on safety and essential performance requirements of cerebral tissue oximeter equipment is useful for:
- Manufacturers and suppliers of medical electrical equipment
- Manufacturers of cerebral tissue oximeter equipment
- Testing centres of medical electrical equipment
- Hospitals, ambulance, airplane, and non-hospital environment where cerebral tissue oximeter equipment is used
Why should you use ISO 80601‑2‑85?
It is vital to maintain adequate oxygen delivery to tissues and organs, particularly the brain when carrying out anaesthetic process. Cerebral oximeters are non-invasive, continuous monitoring devices that are used to ensure that the brain is getting enough oxygen.The estimation of blood oxygen saturation in the brain tissue by cerebral tissue oximeter equipment is widely used in many areas of medicine. ISO 80601‑2‑85 provides you with a complete set of safety and essential performance requirements for cerebral tissue oximeter equipment.
Following the performance guidelines of ISO 80601‑2‑85, you can ensure that your cerebral tissue oximeter equipment adhere to prescribed standards. The testing methods elaborated in ISO 80601‑2‑85 help you to ensure the safety of the cerebral tissue oximeter equipment by providing recommendations relevant to determining the maximum safe temperature of the interface between a cerebral tissue oximeter probe and a patient's tissue.
ISO 80601‑2‑85 discusses both the formula which enables you to evaluate the StO2 accuracy of cerebral tissue oximeter equipment measurements, and the names that are assigned to those formulae.Also lets you verify StO2 accuracy of cerebral tissue oximeter equipment.
ISO 80601‑2‑85 guidelines, also help you ensure essential performance such as accuracy of controls, protection against hazardous outputs, data collection. Guidance on cerebral tissue oximeter probes and probe cable extenders helps you in the manufacturing process of cerebral tissue oximeters and proper assessment, which will ensure the health and safety of the patients and end-users.
