Technical Guideline For Clinical Evaluation Of Pulse Oximeter Equipment


Appendix 4
Technical Guideline for Clinical Evaluation of
Pulse Oximeter Equipment
This guideline is intended to guide registration applicants in
preparing and writing clinical evaluation data for pulse oximeter
equipment (hereinafter referred to as oximeter) and also to provide a
reference for the technical evaluation department to evaluate the
clinical evaluation data for oximeter. This guideline is a general requirement for clinical evaluation
of oximeter. The applicant shall determine whether the content is
applicable according to the specific characteristics of the product. If
not, the reason and corresponding scientific basis shall be explained
in detail, and the content of clinical evaluation data shall be
enriched and refined according to the specific characteristics of the
product. This guideline is a guideline document for applicants and
reviewers. It does not involve administrative matters such as
registration and approval, nor is it enforced as a regulation. If there
are other methods that can meet the requirements of the laws and
regulations, it can also be used, but detailed study and verification

  1. Clinical mechanism, working principle / action mechanism, realization method, for example, measuring principle of functional
    oxygen saturation or oxyhemoglobin, pulse oxygen saturation;
  2. Design features and functions;
  1. Special specification parameters and performance indicators, for example, whether the continuously measured oximeter includes
    too low pulse oxygen saturation (oxygen saturation is less than
  2. Measurement methods of oximeter, for example, single
    measurement or continuous measurement;
  3. The structural form of the oximeter, for example, an
    independent equipment or integrated in multi-parameter module
    equipment or system;
  4. All patient application parts, such as blood oxygen probes, patient cables, extension cables, sensors, bandages, etc. 7. The measurement form of the patient’s application part, for
    example, transmission, reflection or scattering mode, or fiber optic
  5. The structure and configuration of blood oxygen probe, the
    raw materials of each part, and the raw materials of parts expected
    to contact with human body;
  6. The packaging and number of use of the blood oxygen
    probe, for example, sterilized packaging, disposable or reusable. (II) Application Scope and Relevant Information for Clinical Use
    The manufacturer shall clarify the function and intended use of
  1. The use environment of oximeter, for example, whether it is
    used at home or in medical institutions, in hospitals or out of
    hospitals, and whether it is used in the transport process inside and
    outside hospitals;
  2. Alarm function of oximeter;
  3. Use methods of the oximeter;
  4. The intended use site of the application part of the patient;
  5. Taboos for clinical application;
  6. Precautions for the use of oximeter, potential safety hazards
    and use restrictions, possible damage or hazards caused by improper
  7. The protective measures for the operator and the user, and
    the emergency and corrective measures that shall be taken when the
    oximeter has an accident during the correct use. (III) Basic Requirements for Clinical Evaluation
    The manufacturer shall provide clinical evaluation documents
    for pulse oximeter equipment, including the following documents:
  8. Clinical evaluation report of pulse oximeter equipment;
  1. Clinical study report of oxygen saturation accuracy;
  2. Verification report of pulse rate accuracy. (IV) Oximeter as a Multi-parameter Module, Integrated
    Equipment or System
    If the equipment or system integrates the oximeter of a supplier
    that has been approved to the market, without substantially
    changing the oximeter and its permission, the manufacturer of the
    equipment or system shall provide the following data:
  3. Clinical evaluation data of the equipment or system on
    pulse oxygen saturation;
  4. The number of Registration Certificate for Medical Device
    of the approved oximeter;
  5. The clinical study evidence of oxygen saturation accuracy
    and the verification report of pulse rate accuracy of the approved
  6. Verification and validation report of pulse oxygen saturation
    function after integration, for example, the evidence whether the
    integration affects the oximeter module measurement and
    calculation of oxygen saturation and pulse rate and so on. (V) Representativeness of Blood Oxygen Probe
    If the blood oxygen probes have the same composition material