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Medical Instrument Scope Sistagrosa Sa Cert and Scope File 08-25-2020 - 1598381187
Medical Instrument Scope Sistagrosa Sa Cert and Scope File 08-25-2020 - 1598381187
Sistagrosa S.A.
Cdla Guayaquil, Av. Victor H. Sicuret P. Mz11,
S4; Entre Emilio Soro Lenti y Enma E. Ortiz Bermeo
Guayaquil, Ecuador
Fulfills the requirements of
ISO/IEC 17025:2017
In the field of
CALIBRATION
This certificate is valid only when accompanied by a current scope of accreditation document.
The current scope of accreditation can be verified at www.anab.org.
______________________________
R. Douglas Leonard Jr., VP, PILR SBU
Expiry Date: 02 October 2022
Certificate Number: AC-2622
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017.
This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory
quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
SISTAGROSA S.A.
Cdla Guayaquil, Av. Victor H. Sicuret P. Mz11, S4; Entre Emilio Soro
Lenti y Enma E. Ortiz Bermeo
Guayaquil, Ecuador
Víctor Ernesto Pineda Gonzalez Phone: (011) 59 34 2 269 2375
sistagrosa@sistagrosa.com www.sistagrosa.com
CALIBRATION
Valid to: October 2, 2022 Certificate Number: AC-2622
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Mass and Mass Related
Reference Standard,
Expanded Uncertainty of
Parameter/Equipment Range Method, and/or
Measurement (+/-)
Equipment
Non-Invasive Blood Pressure Vital Signs Patient
/Multi-parameter Monitor (30 to 150) mmHg (0.007 4X + 0.5) mmHg Simulator
(Electrical Simulation)1 Fluke PROSIM 8
Invasive Blood Pressure / Vital Signs Patient
Multi-parameter Monitor (0 to 120) mmHg (0.011X + 1.2) mmHg Simulator
(Electrical Simulation)1 Fluke PROSIM 8
Airway Pressure/Pulmonary
Fluke VT900 Gas Flow
Ventilator-Anesthesia (-100 to 100) cmH2O (0.006 3X + 0.083) cmH2O
Analyzer
Machines1
Airway Flow/Pulmonary
Fluke VT900 Gas Flow
Ventilator- Anesthesia (0.5 to 100) l/min (0.02X + 0.008) l/min
Analyzer
Machines1
Thermodynamic
Reference Standard,
Expanded Uncertainty of
Parameter/Equipment Range Method, and/or
Measurement (+/-)
Equipment
Temperature/ Incubator Analyzer
(25 to 40) ºC 0.77 ºC
Infant Incubator1 Fluke INCU
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Calibration and Measurement Capability (CMC) is expressed in terms of the measurement parameter, measurement range, expanded uncertainty of measurement and
reference standard, method, and/or equipment. The expanded uncertainty of measurement is expressed as the standard uncertainty of the measurement multiplied by a
coverage factor of 2 (k=2), corresponding to a confidence level of approximately 95%.
Notes:
1. On-site calibration service is available for this parameter, since on-site conditions are typically more variable than those in the laboratory, larger measurement
uncertainties are expected on-site than what is reported on the accredited scope.
2. X = reading of the unit under test.
3. This scope is formatted as part of a single document including Certificate of Accreditation No. AC-2622.
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