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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 17-19
Standard(Included in ASCA)
ISO  80601-2-85 Edition 1.0 2021-03
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
Scope/Abstract
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 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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
- Subclause 201.12.1.101.2 (a) the phrase "or tissue heamoglobin phantom measurements"

- Annex EE.2.3.4 (g) the phrase "If sufficient statistical power can be achieved using study inclusion criteria, then"
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

This standard is recognized in part because:

- Subclause 201.12.1.101.2 (a) the phrase "or tissue heamoglobin phantom measurements" is in conflict with Subsection 4.1 (Accuracy of Pulse Oximeters) of the FDA Guidance (see reference #1 listed below).

- Annex EE.2.3.4 (g) the phrase "If sufficient statistical power can be achieved using study inclusion criteria, then" is in conflict with Subsection 4.1.1 (In vivo testing for SpO2 accuracy under laboratory conditions) of the FDA Guidance (see reference #1 listed below).
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.2700 Cerebral Oximeter Class 2 QEM
Relevant FDA Guidance and/or Supportive Publications*
1. Pulse Oximeters - Premarket Notification Submissions [510(k)s] - Guidance for Industry and Food and Drug Administration Staff, issued March 4, 2013.

2. FDA CDRH Anesthesiology and Respiratory Therapy Devices Panel Meeting of Medical Devices Advisory Committee, Transcript issued Feb 2, 2024.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Patrick Antkowiak
  FDA/CDRH/OPEQ/OHTV
  240-402-3705
  patrick.antkowiak@fda.hhs.gov
 Sandy Weininger
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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