Scope of Accreditation of Central Directorate of Food ...



|Measured Quantity |Range |Calibration & Measurement Capability* (± |Brief Description of |

| | |vol %) |Measurement & Equipment Used |

|Vaporizing Gas Calibrator |

|Vaporizing Gas |O2 Base: Halothane 0~5 vol % | 0.03 @ 0.6 | In-House Method MICL –WI -02 |Anesthetic Gas Monitor |

| | | | |Manufacturer Riken Keiki , Japan |

| | | | |Model FI-21 |

| | | | |S.N 751050095 |

| | | 0.02 @ 1 | | |

| | | 0.02 @ 2 | | |

| | | 0.04 @ 3 | | |

| | | 0.07 @ 4 | | |

| | | 0.10 @ 5 | | |

| |O2 Base: Isoflurane 0~6 vol % | 0.03 @ 0.6 | | |

| | | 0.02 @ 1 | | |

| | | 0.01 @ 2 | | |

| | | 0.04 @ 3 | | |

| | | 0.07 @ 4 | | |

| | | 0.10 @ 5 | | |

| | | 0.13 @ 6 | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability* (± |Brief Description of |

| | |vol %) |Measurement & Equipment Used |

|Vaporizing Gas Calibrator |

|Vaporizing Gas |O2 Base: Sevoflurane: 0~8 vol % | 0.03 @ 0.6 | In-House Method MICL –WI -02 | Anesthetic Gas Monitor |

| | | | |Manufacturer Riken Keiki , Japan |

| | | | |Model FI-21 |

| | | | |S.N 751050095 |

| | | 0.02 @ 1 | | |

| | | 0.01 @ 2 | | |

| | | 0.04 @ 3 | | |

| | | 0.07 @ 4 | | |

| | | 0.10 @ 5 | | |

| | | 0.13 @ 6 | | |

| | | 0.16 @ 7 | | |

| | | 0.19 @ 8 | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability*(±) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Pulse Oximeter |

| O2% | 35 – 100 % | 1.2 % @ 76 – 100% | In-House Method MICL –WI -05 | SpO2 Simulator |

| | |3.1 % @ 72% | |Manufacturer Fluke ,USA |

| | | | |Index 2XLFE |

| | | | |S.N 9344026 |

|Heart Rate | 30 -250 BPM | 2.9 BPM @ 180 BPM | | |

| | | 2.3 BPM @ 150 BPM | | |

| | | 2.0 BPM @ 120 BPM | | |

| | | 1.9 BPM @ 90 BPM | | |

| | | 1.8 BPM @ 80 BPM | | |

| | | 1.6 BPM @ 70 BPM | | |

| | | 0.82 BPM @ 50 BPM | | |

|Limits Test | |Qualitative | | |

|Pulse Amplitude Test | | | | |

|Electrical Probe Test | | | | |

(*) Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

BPM: Beat Per Minute

|Measured Quantity |Range |Calibration & Measurement Capability*(±) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Defibrillator |

| Output Energy | 0 J : 100 J | 0.31 J @ 10 J | In-House Method MICL –WI -04 | Defibrillator Analyzer |

| | | | |Manufacturer BIO- TEK , USA |

| | | | |Model QED-6 |

| | | | |S.N 9344023 |

| | | 1.1 J @ 50 J | | |

| | 0 J : 1000 J | 4.0 J @ 100 J | | |

| | | 6.0 J @ 200 J | | |

| | | 8.0 J @ 300 J | | |

| | | 9.2 J @ 360 J | | |

|Measuring Synchronization |0-199.9 ms | 2.0 ms | | |

|Charge Time | 0 – 60 sec | 0.01 sec @ 360 J | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability*(±) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Non-Invasive Blood Pressure Measurement Instrument |

| Pressure Measurement | Up to 400 mmHg | Adult -Standard Blood Pressure | In-House Method MICL –WI -06 | Non-Invasive Blood Pressure Analyzer |

| | | | |Manufacturer BIO - TEK , USA |

| | | | |Model BP Pump 2 |

| | | | |S.N 9342005 |

| | | 1.5 / 1.3 mmHg @ 60 / 30 mmHg | | |

| | | 1.8 / 1.9 mmHg @ 120 / 80 mmHg | | |

| | | 2.2 / 2.5 mmHg @ 200 / 150 mmHg | | |

| | |Patient Condition | | |

| | | 2.0 / 1.8 mmHg @ 110 / 80 mmHg | | |

| | | 1.8 / 1.8 mmHg @ 120 / 105 mmHg | | |

| | | 1.8 / 1.8 mmHg @ 120 / 60 mmHg | | |

| | |Respiratory Artifact | | |

| | |Spontaneous Breath | | |

| | | 2.7 / 2.8 mmHg @ 112/47 mmHg | | |

| | | 3.2 / 1.7 mmHg @ 149/65 mmHg | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

BPM: Beat Per Minute

|Measured Quantity |Range |Calibration & Measurement Capability*(±) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Non-Invasive Blood Pressure Instrument |

| Pressure Measurement | Up to 400 mmHg |Neonate | In-House Method MICL –WI -06 | Non-Invasive Blood Pressure Analyzer |

| | | | |Manufacturer BIO - TEK , USA |

| | | | |Model BP Pump 2 |

| | | | |S.N 9342005 |

| | | 1.5 / 1.6 mmHg @ 35/15 mmHg | | |

| | | 1.6 / 1.6 mmHg @ 60/30 mmHg | | |

| | | 1.6 / 1.4 mmHg @ 80/50 mmHg | | |

| | | 2.0 / 1.8 mmHg @ 100/70 mmHg | | |

| | | 2.1 / 1.6 mmHg @ 70/50 mmHg | | |

| | | 1.3 / 1.3 mmHg @ 20/10 mmHg | | |

|Pressure Source/Gauge | Up to 400 mmHg | 1.6 @ 100 mmHg | | |

| | | 2.1 @ 200 mmHg | | |

| | | 2.5 @ 250 mmHg | | |

|Leak Test | Up to 400 mmHg | 0.06 mmHg /min @ 200 ,250,300 mmHg | | |

|Relief Pressure Test | Up to 400 mmHg | 7.5 mmHg | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement |Brief Description of |

| | |Capability*(±Watt) |Measurement & Equipment Used |

|Calibration of Electrosurgical Unit |

|HF Power |1- 400 Watt | At Pure | In-House Method MICL –WI -03 | Electrosurgical Analyzer |

| | | | |Manufacturer BIO- TEK , USA |

| | | | |Model RF 303 |

| | | | |S.N. 9345014 |

| | | 3.0 @ 50 Watt | | |

| | | 8.8 @ 175 Watt | | |

| | | 15.0 @ 300 Watt | | |

| | |At Blend 1 | | |

| | | 3.0 @ 50 Watt | | |

| | | 7.5 @ 150 Watt | | |

| | | 12.5 @ 250 Watt | | |

| | |At Blend 2 | | |

| | | 3.0 @ 50 Watt | | |

| | | 6.3 @ 125 Watt | | |

| | | 10.0 @ 200 Watt | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement |Brief Description of |

| | |Capability*(±Watt) |Measurement & Equipment Used |

|Calibration of Electrosurgical Unit |

|HF Power |1- 400 Watt |At Blend 3 | In-House Method MICL –WI -03 | Electrosurgical Analyzer |

| | | | |Manufacturer BIO- TEK , USA |

| | | | |Model RF 303 |

| | | | |S.N. 9345014 |

| | | 3.0 @ 50 Watt | | |

| | | 5.0 @ 100 Watt | | |

| | | 7.5 @ 150 Watt | | |

| | |At Spray | | |

| | | 3.0 @ 20 Watt | | |

| | | 3.5 @ 70 Watt | | |

| | | 6.0 @ 120 Watt | | |

| | | Forced | | |

| | | 3.0 @ 20 Watt | | |

| | | 3.5 @ 70 Watt | | |

| | | 6.0 @ 120 Watt | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability*(±) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Electrosurgical Unit |

| HF Power |1- 400 Watt |Soft | In-House Method MICL –WI -03 | Electrosurgical Analyzer |

| | | | |Manufacturer BIO- TEK , USA |

| | | | |Model RF 303 |

| | | | |S.N. 9345014 |

| | | 3.0 Watt @ 20 Watt | | |

| | | 3.5 Watt @ 70 Watt | | |

| | | 7.5 Watt @ 150 Watt | | |

| | |Bipolar (max. 50 Watt) | | |

| | | 3.0 Watt @ 10 Watt | | |

| | | 3.0 Watt @ 30 Watt | | |

| | | 3.0 Watt @ 50 Watt | | |

| | |Micro bipolar | | |

| | | 3.0 Watt @ 10 Watt | | |

| | | 3.0 Watt @ 30 Watt | | |

| | | 3.0 Watt @ 50 Watt | | |

|HF Current |30-2500 mA RMS |Due to active electrode | | |

| | |Pure 1 15.0 mA | | |

| | |Blend 1 15.0 mA | | |

| | |Blend 2 15.0 mA | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability*(± mA) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Electrosurgical Unit |

|HF Current (mA) |30 -2500 mA RMS | Blend 3 15.0 mA | In-House Method MICL –WI -03 | Electrosurgical Analyzer |

| | | | |Manufacturer BIO- TEK , USA |

| | | | |Model RF 303 |

| | | | |S.N. 9345014 |

| | | Spray 15.0 mA | | |

| | | Forced 15.0 mA | | |

| | | Soft 15.0 mA | | |

| | | Bipolar 15.0 mA | | |

| | | Micro bipolar 15.0 mA | | |

| | |Due to dispersive electrode | | |

| | | Pure 1 15.0 mA | | |

| | | Blend 1 15.0 mA | | |

| | | Blend 2 15.0 mA | | |

| | | Blend 3 15.0 mA | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability*(± mA) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Electrosurgical Unit |

|HF Current (mA) |30 -2500 mA |Spray 15.0 mA | In-House Method MICL –WI -03 | Electrosurgical Analyzer |

| | | | |Manufacturer BIO- TEK , USA |

| | | | |Model RF 303 |

| | | | |S.N. 9345014 |

| | |Forced 15.0 mA | | |

| | | Soft 15.0 mA | | |

| | |Bipolar 15.0 mA | | |

| | |Micro bipolar 15.0 mA | | |

|CQM (REM) Test |50 – 250 Ω |Qualitative | | |

(*)Calibration & Measurement Capabilities are to be expressed as expanded uncertainty (k=2) i.e. providing a level of confidence of approximately 95%.

|Measured Quantity |Range |Calibration & Measurement Capability*(± mA) |Brief Description of |

| | | |Measurement & Equipment Used |

|Calibration of Ventilator Unit |

|Tidal Volume |High Flow => ± 60l | 24 ml @800ml | In-House Method MICL –WI -01 | Gas Flow Analyzer |

| |Low Flow => ± 60l |16 ml @500ml | |Manufacturer FLUKE BIOMEDICAL , USA |

| | |10 ml @300ml | |Model VT Plus HF |

| | |7.8 ml @250ml | |S.N. 9340035 |

| | |2.0 ml @50ml | | |

| | |2.0 ml @30ml | | |

|Minute Volume |0-60L | 0.24 lpm @800ml | | |

| | |0.32 lpm @500ml | | |

| | |0.18 lpm @300ml | | |

| | |0.17 lpm @250ml | | |

| | |0.03 lpm @50ml | | |

| | |0.03 lpm @30ml | | |

|Breath Rate |0.5-150bpm | 0.12 bpm | | |

|I:E Ratio |1:200-200:1 | 0.1 | | |

|Inspiratory Time |0-60s | 0.02s | | |

|Expiratory Time |0-90s | 0.01s | | |

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المجلـــس الوطنـــى للإعتمــاد

إيجاك

Egyptian Accreditation Council

EGAC

Kornish El-Maadi, Riad El-Maadi Tower 1 - Cairo – Egypt

Tel.: (202) 5275220/5275224/5275225/5275227

Fax: (202) 5275226

كورنيش المعادى – برج رياض المعادى1- القاهرة – مصر

تليفون : 5275227/ 5275225 / 5275224 /5275220 (202 )

فاكس : 5275226 (202)

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