and object Clause 1 of the general standard applies, except as follows. NOTE The general standard is IEC 60601-:2005+AMD1:2012+AMD2:2020.
* Scope Replacement: This document applies to basic safety and essential 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. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use. NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature. Not included within the scope of this document are
This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard. NOTE 2 See also 4.2 of the general standard. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability. This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment. NOTE 3 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
The object of this document is to establish particular basic safety and essential performance requirements for cerebral tissue oximeter equipment [as defined in 201.3.202] and its accessories. NOTE 1 Accessories are included because the combination of the cerebral tissue oximeter monitor and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of cerebral tissue oximeter equipment. NOTE 2 This document has been prepared to address the relevant International Medical Device Regulators Forum (IMDRF) essential principles and labelling guidances as indicated in Annex JJ. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex KK. NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [20] as indicated in Annex LL.
| SDO | CSA: Canadian Standards Association |
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| Publication Date | Jan. 1, 2021 |
| Language | en - English |
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