JJF 1234-2018 English PDF (JJF1234-2018)

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JJF 1234-2018: Calibration Specification for Ventilators
JJF 1234-2018
NATIONAL METROLOGY TECHINICAL SPECIFICATION
OF THE PEOPLE’S REPUBLIC OF CHINA
Calibration Specification for Ventilators
ISSUED ON: FEBRUARY 27, 2018
IMPLEMENTED ON: AUGUST 27, 2018
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine
Table of Contents
Foreword ... 5 
1 Scope ... 6 
2 References ... 6 
3 Terms and Definitions ... 6 
4 Overview ... 8 
5 Metrological Characteristics ... 8 
6 Calibration Conditions ... 9 
7 Calibration Items and Calibration Methods ... 10 
8 Expression and Processing of Calibration Result ... 15 
9 Time Interval of Re-calibration ... 16 
Appendix A (Recommended) Format of Original Calibration Record of Ventilator
... 1 
Appendix B (Recommended) Format of Inner Page of Calibration Certificate . 1 
Appendix C An Example of Uncertainty Evaluation of Tidal Volume Calibration
Result of Ventilator ... 5 
Appendix D An Example of Uncertainty Evaluation of Inspiration Flow Oxygen
Concentration Calibration Result of Ventilator ... 8 
Calibration Specification for Ventilators
1 Scope
This Specification is applicable to the calibration of invasive ventilator (hereinafter
referred to as ventilator).
This Specification is inapplicable to non-invasive ventilator, high-frequency jet
ventilator, high-frequency oscillatory ventilator or emergency ventilator; nor is it
applicable to equipment merely used to increase patients’ ventilatory capacity in
hospitals.
2 References
This Specification takes the following documents as references:
GB/T 8982-2009 Oxygen Supplies for Medicine and Aircraft Breathing
GB 9706.28-2006 Medical Electrical Equipment - Part 2: Particular Requirements for
the Safety of Lung Ventilators - Critical Care Ventilators
YY 0600.3-2007 Lung Ventilators for Medical Use - Particular Requirements for Basic
Safety and Essential Performance - Part 3: Emergency and Transport Ventilators
YY 0601-2009 Medical Electrical Equipment - Particular Requirements for Basic Safety
and Essential Performance of Respiratory Gas Monitors
Pharmacopoeia of the People’s Republic of China (Version 2015)
In terms of references with a specified date, only versions with a specified date are
applicable to this Specification. In terms of references without a specified date, the
latest version (including all the modifications) is applicable to this Specification.
3 Terms and Definitions
3.1 Ventilators
Ventilator refers to an automatic device designed to increase or provide ventilation for
patients.
3.2 Ventilation Mode
Ventilation mode refers to the mechanical ventilation treatment method of ventilator,
Positive end-expiratory pressure refers to the pressure value of end-expiratory airway.
It is expressed in (kPa).
3.12 Test Lung
Test lung refers to a mechanical ventilation load that simulates a patient’s chest and
lung characteristics (pulmonary compliance and airway resistance parameters are
fixed, graded or adjustable), including test lung for adults, test lung for infants, or hybrid
test lung.
3.13 Lung Compliance, C
Lung compliance refers to within a unit pressure, the volume of gas that lung can hold.
It is expressed in (mL/kPa).
3.14 Airway Resistance, R
Airway resistance refers to within a unit flow, the pressure value that airway can
generate. It is expressed in [kPa/(Ls-1)].
NOTE: 1 kPa = 10 mbar = 10 cmH2O = 10 hPa.
4 Overview
Ventilator is a kind of ventilation equipment for clinical treatment of patients with
respiratory insufficiency or respiratory failure. The fundamental principle of ventilator is
to mix medical air and oxygen, and in accordance with certain ventilation mode and
respiratory airway mechanical parameters (tidal volume, respiratory frequency, I:E,
airway peak pressure, positive end-expiratory pressure and inspiration flow oxygen
concentration, etc.), through patient’s circuit, deliver the air-oxygen mixed gas to the
patient, so as to force or assist the patient to breathe, thereby, maintaining the patient’s
respiratory function.
5 Metrological Characteristics
5.1 Tidal Volume
In terms of ventilator whose delivered tidal volume (VT) > 100 mL, or, whose minute
volume > 3 L/min, the relative indication error shall not exceed ± 15%. In terms of
ventilator whose delivered tidal volume (VT) ≤ 100 mL, or, whose minute volume ≤ 3
L/min, it shall satisfy relevant requirements of the instruction for use.
5.2 Respiratory Frequency
The maximum permissible error of respiratory frequency (f): ± 10% of set value or ± 1
number of times / minutes. The greater absolute value between them shall prevail.
1. The compatibility of gas flow measurement: air, oxygen and air-oxygen mixed gas.
2. Reference or compensation standard of gas flow measurement: equipped with the
compensation capability in ambient temperature, ambient atmospheric pressure (ATP);
standard temperature (0 °C or 21 °C), standard atmospheric pressure (101.325 kPa)
(STP); body temperature, ambient atmospheric pressure, saturated with water vapor
(BTPS), etc.
6.2.2 Test lung
a) Volume of test lung: (0 ~ 300) mL and (0 ~ 1,000) mL;
b) Lung compliance: 50 mL/kPa, 100 mL/kPa, 200 mL/kPa and 500 mL/kPa;
may be selected in accordance with demands;
c) Airway resistance: 0.5 kPa / (Ls-1), 2 kPa / (Ls-1) and 5 kPa / (Ls-1); may be
selected in accordance with demands.
6.2.3 Calibration medium
Medical oxygen and medical compressed air used for the calibration of ventilator shall
comply with the requirements of GB/T 8982-2009 Oxygen Supplies for Medicine and
Aircraft Breathing and Pharmacopoeia of the People’s Republic of China (Version
2015).
7 Calibration Items and Calibration Methods
7.1 Appearance and Functionality Inspection
7.1.1 The equipment to be calibrated shall be intact in structure, and free of defects
and mechanical damages that would affect the normal operation and hinder the
reading.
7.1.2 The power switch of the equipment to be calibrated shall be reliably installed; the
on-off status shall be obvious; the control button shall be clearly marked and easy to
control.
7.1.3 The equipment to be calibrated shall be marked with the name of instrument,
manufacturer, model and exit-factory No.
7.1.4 The equipment to be calibrated shall work normally after being turned on.
7.2 Tidal Volume
7.2.1 As it is shown in Figure 1, correctly connect the ventilator to be calibrated, the
ventilator tester and the test lung. In addition, in accordance with the requirements of
the instruction for use, start the pre-heating of related equipment.
--- arithmetic mean value of 3 monitored values of airway peak pressure of calibrated
ventilator, expressed in (kPa);
---arithmetic mean value of 3 measured values of tester, expressed in (kPa).
NOTE: when the calibrated instrument does not have the airway peak pressure monitoring
function, in Formula (3) refers to the set value of airway peak pressure of the
calibrated ventilator.
7.5 Positive End-expiratory Pressure
7.5.1 In accordance with Figure 1, connect the calibrated ventilator, the ventilator tester
and the test lung. Then, under the condition: PCV mode or VCV mode, and IPL = 2.0
kPa or VT = 400 mL; f = 15 times/min; I:E = 1:2; FiO2 = 40%, respectively calibrate the
calibration point of 0.2 kPa, 0.5 kPa, 1.0 kPa, 1.5 kPa and 2.0 kPa positive end-
expiratory pressure. For each calibration point, respectively record for 3 times the
monitored value of positive en...