Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (Adopted ISO 80601-2-85:2021, first edition, 2021-03, with Canadian deviations)
This is the first edition of CSA C22.2 No. 80601-2-85, Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-85 (first edition, 2021-03). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope and object
Clause 1 of the general standard applies, except as follows.
NOTE The general standard is IEC 60601-:2005+AMD1:2012+AMD2:2020.
201.1.1 * Scope
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:
- invasive tissue or vascular oximeters;
- oximeters that require a blood sample from the patient;
- equipment measuring dissolved oxygen;
- ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71;
- ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601-2-61 ;
- ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head.
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 126.96.36.199 and 188.8.131.52 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  as indicated in Annex LL.