ISO80601测试专项项目.doc

201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS
IEC 60601-1:+A1:, Clause 9 applies, except as follows:
Additional subclauses:
201.9.6.2.1.101 * Additional requirements for audible acoustic energy
The A-weighted sound pressure level emitted by the SLEEP APNOEA BREATHING THERAPY EQUIPMENT shall be measured in accordance with ISO 4871:1996 and ISO 3744: using engineering method grade 2 and disclosed in the instructions for use. The A-weighted sound power level shall be calculated according to 8.1 of ISO 3744: and disclosed in the instructions for use.
Check compliance with the following test:
a) Place the SLEEP APNOEA BREATHING THERAPY EQUIPMENT on a sound-reflecting plane and attach the least favorable BREATHING GAS PATHWAY from those indicated in the instructions for use.
NOTE the least favorable BREATHING GAS PATHWAY configuration can vary by mode, as applicable.
b) If a HUMIDIFIER is provided with or specified in the ACCOMPANYING DOCUMENTS of the SLEEP APNOEA
BREATHING THERAPY EQUIPMENT, include the HUMIDIFIER in the test. Fill the HUMIDIFIER to the least favorable level.
c) Connect the standard resistance, 40 mm length and outlet angle of 45° (as indicated in Figure 201.101) to the PATIENT-CONNECTION PORT.
d) Acoustically isolate the BREATHING TUBES and the gas leaving at the resistance placed at the PATIENTCONNECTION PORT by a suitable means out of the testing area so that the noise caused by the BREATHING TUBE and the gas flow do not interfere with the sound measurement of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT.
e) Set the SLEEP APNOEA BREATHING THERAPY EQUIPMENT to the least favourable mode and flow pattern, as applicable, that generates a continuous pressure of 10 hPa (10 cmH2O) at the PATIENT-CONNECTION PORT.
NOTE The least favorable mode, breath type and flow pattern can vary by BREATHING GAS PATHWAY configuration.
f) Using a microphone of the sound level meter complying with the requirements of type 1 instruments specified in IEC 61672-1:, measure the sound pressure levels at 10 positions in a hemisphere with a radius from the geometric centre of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT as specified in 7.2 of ISO 3744:.
g) Calculate the A-weighted sound pressure level averaged over the measurement surface according to 8.1 of ISO 3744:.
h) Calculate the A-weighted sound power level according to 8.6 of ISO 3744:.
i) Verify that the A-weighted background level of extraneous noise is at least 6 dB below that measured during the test.
j) Take measurements using the frequency-weighting characteristic A and the time-weighting characteristic F on the sound level meter in a free field over a reflecting plane as specified in ISO 3744:. Average the values in accordance with subclause 8.1 of ISO 3744:.
k) Repeat b) to j) for each HUMIDIFIER provided with or specified in the ACCOMPANYING DOCUMENTS.
l) Ensure that the measured sound pressure level is less than that disclosed in the instructions for use.

201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
Amendment (add between the existing paragraphs):
Over the RATED flow rate range and at the maximum RATED operating temperature, the temperature of the delivered gas of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, both with and without a humidifier, shall not exceed an energy equivalent to 43 °C and 100 % relative humidity (a specific enthalpy not to exceed
197 kJ/m3 dry gas) when averaged over 120 s.
Table 201.101 contains examples of combinations of temperature and relative humidity with such a specific enthalpy.
Table 201.101 — Examples of permissible combinations of temperature and relative humidity
Temperature °C
Relative humidity %
43
100
44
95
45
90
48
76
50
68

201.12.1.101 Stability of static AIRWAY PRESSURE ACCURACY (long-term accuracy)
The stability of the static AIRWAY PRESSURE ACCURACY for any type of SLEEP APNOEA BREATHING
THERAPY EQUIPMENT when operating in NORMAL CONDITION shall be disclosed in the instructions for use, as the maximum bias error and maximum linearity error.
EXAMPLE ± (3,0 hPa + 5 % of the set pressure)
NOTE 1 This information should be expressed in graphical or tabular form.
The accuracy of the performance of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT shall either be: determined for each BREATHING GAS PATHWAY configuration indicated in the instructions for use; or determined for the worst case BREATHING GAS PATHWAY configuration indicated in the instructions for use.
If worst case BREATHING GAS PATHWAY configurations are used, the rationale for their selection shall be documented in the RISK MANAGEMENT FILE.
Check compliance by inspection of the RISK MANAGEMENT FILE for the rationale, if applicable, and by inspection of the instructions for use with the following tests:
a）Set up the SLEEP APNOEA BREATHING THERAPY EQUIPMENT for NORMAL USE according to Figure 201.102 with the pressure set to 10 hPa (10 cm H2O) in CPAP mode. For BI-LEVEL PAP SLEEP APNOEA BREATHING THERAPY EQUIPMENT without a CPAP mode, adjust the inspiratory and expiratory pressures to the same value. Switch off all comfort features of the ME EQUIPMENT. Place the standard resistance (Figure 201.101) at the PATIENT-CONNECTION PORT.
NOTE 2 Comfort features do include, but are not limited to, e.g. automatic start / stop function, fall-to-sleep ramps, automatic inspiratory pressure increase or automatic expiratory pressure decrease.
b) Using a pressure-measuring device, measure the pressure at least once per second at the PATIENTCONNECTION PORT of the BREATHING GAS PATHWAY and record, each minute, the average pressure over each averaging interval of 1 min for a period of 8 h.
c) Calculate the most positive and most negative pressure difference (if applicable) referenced to the set pressure on the SLEEP APNOEA BREATHING THERAPY EQUIPMENT.
d) Verify that the average measured static pressure is within the static AIRWAY PRESSURE ACCURACY limit disclosed in the instructions for use.

Key
1 – SLEEP APNOEA BREATHING THERAPY EQUIPMENT
2 – BREATHING GAS PATHWAY
3 – standard resistance (see Figure 201.101)
4 – pressure meter
5 – PATIENT-CONNECTION PORT
Figure 201.102 – Test set-up for static AIRWAY PRESSURE ACCURACY in NORMAL USE

201.12.1.102 Stability of dynamic AIRWAY PRESSURE ACCURACY (short-term accuracy)
201.12.1.102.1 CPAP mode
With the SLEEP APNOEA BREATHING THERAPY EQUIPMENT operating in CPAP mode in NORMAL CONDITION, the stability of the dynamic AIRWAY PRESSURE ACCURACY shall be disclosed in the instructions for use, as the maximum bias error and maximum linearity error.
EXAMPLE ± (3,0 hPa + 5 % of the set pressure)
NOTE 1 This information should be expressed in graphical or tabular form.
The accuracy of the performance of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT shall either be:
-determined for each BREATHING GAS PATHWAY configuration indicated in the instructions for use; or
-determined for the worst case BREATHING GAS PATHWAY configuration indicated in the instructions for use.
If worst case BREATHING GAS PATHWAY configurations are used, the rationale for their selection shall be documented in the RISK MANAGEMENT FILE.
Check compliance by inspection of the RISK MANAGEMENT FILE for the rationale, if applicable, and by inspection of the instructions for use with the following tests:
a) Connect the PATIENT-CONNECTION PORT to a pressure-measuring device and a pump that produces a sinusoidal cycle with an inspiratory: expiratory phase time (I/E ratio) of 1/1 and a breathing frequency of 10 breaths/min according to Figure 201.103. Switch off all comfort features of the ME EQUIPMENT. Monitor and measure the flow rate and pressure using a pressure- and flow rate-measuring device at the PATIENTCONNECTION PORT.
NOTE 2 The dead space of the test lung should be less than the tidal volume used.
NOTE 3 All measurement uncertainties of the test apparatus used for these tests (specified in a) and b) are to be included in the calculation of the results, i.e. uncertainties are to be added to the differences measured.
b) Set the pressure to the minimum pressure setting.
c) Set lung parameters according to Table 201.102 with a tidal volume, Vt, of approximately 500 ml.
d) Simulate an apnoea event by turning the pump off for at least 1 min.
e) For each cycle, calculate the most positive and negative pressure difference from the set value. Average these results over a period of 5 min.
f) Record the pressure and flow rate waveforms. If necessary, adjust the settings until the breathing frequency and stroke volume match the desired settings.
g) Record the dynamic high and low pressure measurements as peak-to-peak values. Subtract the recorded dynamic low pressure from the recorded dynamic high pressure.
h) Verify that the average measured dynamic pressure is within the static AIRWAY PRESSURE ACCURACY limit disclosed in the instructions for use.
i) Repeat steps d) to h) for each set pressure indicated in Table 201.102.
j) Repeat b) to i) for each breath rate indicated in Table 201.102.

Key
1 – SLEEP APNOEA BREATHING THERAPY EQUIPMENT
2 – BREATHING GAS PATHWAY
3 – Standard resistance (see Figure 201.101)
4 – Flow meter
5 – Pressure-measuring device
6 – Pump that produces a sinusoidal cycle
7 – PATIENT-CONNECTION PORT
Figure 201.103 – Test set-up for dynamic AIRWAY PRESSURE ACCURACY in NORMAL USE
Table 201.102 — Parameters for dynamic AIRWAY PRESSURE ACCURACY testing

Fraction of the maximum adjustable pressure
P a
(hPa)
(cm H2O)
Pmin
Pmin +
¼ (Pmax - Pmin)
Pmin +
½ (Pmax - Pmin)
Pmin +
¾ (Pmax - Pmin)
Pmax
f
(breaths/min)
10, 15, and 20
Vt
(ml)
500
a Set pressure rounded to the nearest whole integer
Where
Pmin is the minimum pressure setting.
Pmax is the maximum pressure setting.

201.12.1.102.2 BI-LEVEL POSITIVE AIRWAY PRESSURE mode
With the SLEEP APNOEA BREATHING THERAPY EQUIPMENT operating in NORMAL CONDITION, the stability of the dynamic AIRWAY PRESSURE ACCURACY for both the inspiratory and expiratory pressure levels shall be disclosed in the instructions for use, as the mean and standard deviation of the error between the set values and the delivered values. The technical description shall disclose which percentage of each inspiratory and expiratory phase is taken into the calculation for determining the accuracy as well as where these time slots are located within the inspiratory and the expiratory phases.
NOTE 1 This information should be expressed in graphical or tabular form.
The accuracy of the performance of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT shall either be:
-determined for each BREATHING GAS PATHWAY configuration indicated in the instructions for use; or
-determined for the worst case BREATHING GAS PATHWAY configuration indicated in the instructions for use.
If worst case BREATHING GAS PATHWAY configurations are used, the rationale for their selection shall be documented in the RISK MANAGEMENT FILE.
Check compliance by inspection of the RISK MANAGEMENT FILE for the rationale, if applicable, and by inspection of the instructions for use with the following tests:
a) Connect the PATIENT-CONNECTION PORT to a pressure-measuring device and a pump that produces a sinusoidal cycle with an inspiratory:expiratory phase time (I/E ratio) of 1/1 and a breathing frequency of 10 breaths/min according to Figure 201.103. Switch off all comfort features of the ME EQUIPMENT. Monitor and measure the flowrate and pressure using a pressure- and flowrate-measuring device at the PATIENTCONNECTION
PORT.
NOTE 2 The deadspace of the test lung should be less than the tidal volume used.
NOTE 3 All measurement uncertainties of the test apparatus used for these tests (specified in a) and b) ) are to be included in the calculation of the results, i.e. uncertainties are to be added to the differences measured.
b) Set the pressure to the minimum pressure setting.
c) Set lung parameters according to Table 201.103 with a tidal volume, Vt, of approximately 500 ml.
NOTE 4 To accommodate the different control mechanisms of different designs during the change from the inspiratory phase to the expiratory phase and vice versa measure the inspiratory pressure and expiratory pressures as specified in the technical description.
d) Record the pressure and flowrate waveforms. If necessary, adjust the settings until the breathing frequency and stroke volume match the desired settings.
e) Simulate an apnoea event by turning the pump off for at least 1 min.
f) For each cycle, determine the extreme inspiratory pressure difference from the inspiratory set value. Calculate the mean and standard deviation of these pressures over a period of 5 min.
g) For each cycle, determine the extreme expiratory pressure difference from the expiratory set value. Calculate the mean and standard deviation of these pressures over a period of 5 min.
h) Verify that the mean and standard deviation of the dynamic inspiratory and expiratory pressure errors are within the limits disclosed in the instructions for use.
i) Repeat steps e) to h) for each set pressure indicated in Table 201.103.
j) Repeat b) to i) for each breath rate indicated in Table 201.103.
Table 201.103 — Parameters for dynamic AIRWAY PRESSURE ACCURACY testing for POSITIVE AIRWAY PRESSURE mode

Fraction of the maximum adjustable pressure
P a，inspiratory
(hPa)
(cm H2O)
Pmin+4
Pmin +2+
¼ (Pmax - Pmin)
Pmin +2+
½ (Pmax - Pmin)
Pmin +2+
¾ (Pmax - Pmin)
Pmax
P a，expiratory
(hPa)
(cm H2O)
Pmin
Pmin -2+
¼ (Pmax - Pmin)
Pmin-2 +
½ (Pmax - Pmin)
Pmin -2+
¾ (Pmax - Pmin)
Pmax-4
f
(breaths/min)
10, 15, and 20
Vt
(ml)
500
a Set pressure rounded to the nearest whole integer
Where
Pmin is the minimum pressure setting.
Pmax is the maximum pressure setting.

201.12.1.103 Maximum flow rate
The flow rate capability of SLEEP APNOEA BREATHING THERAPY EQUIPMENT over the set pressure range shall be disclosed in the instructions for use. The disclosure may be in tabular form.
Check compliance by inspection of the instructions for use and with the following tests:
a) Set up SLEEP APNOEA BREATHING THERAPY EQUIPMENT with a 1,9 ± 0,15 m BREATHING TUBE. Switch off all comfort features of the ME EQUIPMENT.
b) Apply a pressure-measuring device and flow rate meter to the PATIENT-CONNECTION PORT.
c) Apply an adjustable valve at the PATIENT-CONNECTION PORT.
d) Set the pressure to the minimum setting and adjust the valve to achieve (40 ± 2) l/min and measure the actual pressure delivered to the PATIENT-CONNECTION PORT.
e) Adjust the valve until the actual measured pressure is reduced by 1 hPa ± 0,1 hPa
(1 cm H2O ± 0,1 cm H2O). Read the corresponding measured pressure and flow rate value.
f) Repeat step e) 10 times and record the average value of these 10 measurements.
g) Verify that the SLEEP APNOEA BREATHING THERAPY EQUIPMENT can deliver at least as much flow as is in