CERTIFICATE OF ACCREDITATION
ANSI National Accreditation Board
11617 Coldwater Road, Fort Wayne, IN 46845 USA
This is to certify that
Laboratorio de Metrología Biomédica SAS – MET&CAL
CARRERA 43 No. 74 – 155 – TERCER PISO
Barranquilla, Colombia
has been assessed by ANAB and meets the requirements of international standard
ISO/IEC 17025:2017
while demonstrating technical competence in the field of
CALIBRATION
Refer to the accompanying Scope of Accreditation for information regarding the types of
activities to which this accreditation applies
AC-1948
Certificate Number
Certificate Valid Through: 05/14/2021
Version No. 009 Issued: 05/14/2019
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
Laboratorio de Metrología Biomédica SAS - MET&CAL
CARRERA 43 No. 74 – 155 – TERCER PISO
Barranquilla, Colombia
Jose Arturo Romero Phone: (011) 57 5 385 0007
[email protected] www.metandcal.com
CALIBRATION
Valid to: May 14, 2021 Certificate Number: AC-1948
Electrical – DC/Low Frequency1
Reference Standard,
Expanded Uncertainty of
Parameter / Equipment Range Method and/or
Measurement2 (+/-)
Equipment
Internal Procedure # MC-
DT-I-004 using Fluke
Energy/Defibrillator (10 to 360) J (0.011X + 0.58) J
Impulse 7000DP
Defibrillator Analyzer
(5 to 300) W:
Internal Procedure # MC-
at 200 Ω
DT-I-022 using Fluke QA
Power/Electrosurgical Unit at 300 Ω (0.021X + 0.97) W
ES II Electrosurgery
at 400 Ω
Analyzer
at 500 Ω
Mass and Mass Related1
Reference Standard,
Expanded Uncertainty of
Parameter / Equipment Range Method and/or
Measurement2 (+/-)
Equipment
Internal Procedure MC-DT-
I-006 using Infusion Pump
Flow/Infusion Pump (16 to 200) ml/h (0.008 3X + 0.017) ml/h
Analyzer (Fluke IDA 4
Plus)
OIML R16-1 method using
Vital Signs Patient
Pressure/ Simulators (Fluke PROSIM
(0 to 300) mmHg (0.001 9X + 0.61) mmHg
blood pressure cuff 8, Fluke BP PUMP 2L,
Fluke PROSIM 4,
Fluke700P04)
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Mass and Mass Related1
Reference Standard,
Expanded Uncertainty of
Parameter / Equipment Range Method and/or
Measurement2 (+/-)
Equipment
(-14 to -1.2) psig 0.086 psi CEM ME-003 method
(3 to 30) psig 0.0093 psi using reference pressure
(30 to 300) psig 0.1 psi gauges
Pressure/ (300 to 1 000) psig 1.3 psi (Fluke 717 30G, Fluke 717
Pressure gauges (1 000 to 10 000) psig 1.4 psi 300G, Fluke 2700G-G70M)
or pressure transducers and
(0.25 to 1) inH2O 0.009 6 inH2O readouts (Fluke 700P series
modules)
Internal Procedure # MC-
DT-I-007 using Fluke
Non-Invasive Blood Pressure
(30 to 150) mmHg 0.79 mmHg PROSIM 8 or Fluke BP
Monitoring Devices
PUMP 2L Vital Signs
Patient Simulator
Internal Procedure # MC-
Invasive Blood Pressure
(0 to 120) mmHg 1.1 mmHg DT-I-012 using Fluke MPS
Monitoring Devices
450 Patient Simulator
OIML Class M1
5 g to 5 kg 0.82 g
weights and SIM
Non-Automatic Weighing 5 g to 20 kg 4.1 g
MWG7/cg-01/v.00 utilized
Instruments (Scales) 100 g to 200 kg 21 g
for the calibration of the
100 g to 400 kg 85 g
weighing system
Thermodynamic
Reference Standard,
Expanded Uncertainty of
Parameter / Equipment Range Method and/or
Measurement2 (+/-)
Equipment
Internal Procedure # MC-
DT-I-014 using Fluke INCU
Temperature/
(25 to 40) ºC 0.98 ºC Incubator Analyzer,
Infant Incubator1
MadgeTech HiTemp 140
Datalogger
CEM TH-001 method using
Temperature/
POLYSCIENCE PP07R-
Digital Thermometers,
20L External Digital
Direct Indication
(-10 to 100) °C 0.17 ºC Thermometer and
Thermometers,
Circulating Bath, Fluke
Temperature Data Loggers,
1524 Digital Thermometer
Bimetallic Thermometers
Temperature sensor PT100.
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Thermodynamic
Reference Standard,
Expanded Uncertainty of
Parameter / Equipment Range Method and/or
Measurement2 (+/-)
Equipment
CEM TH-007 method using
Temperature/ POLYSCIENCE Reference
Environmental Digital Thermometer, Fluke
(17 to 40) °C 0.17 ºC
Thermometers, 1524 Digital Thermometer
Thermo-Hygrometers Temperature sensor PT100
and Oven
Humidity/ CEM TH-007 method using
Thermo-Hygrometers, Vaisala Humidity and
(40 to 90) %RH 1.1 %RH
Hygrometers, Temperature Meter and
Humidity Data Loggers Humidity Chamber
Internal Procedure MC-DT-
I-042 using NT-04
Fluke 1524 Digital
Temperature/
Thermometer Temperature
Coolers/Ovens/Circulating (-10 to 100) °C 0.18 ºC
sensor PT100, MadgeTech
Baths1
HiTemp 140 Datalogger,
MicroDaq EL-USB-1
Datalogger
Time and Frequency1
Reference Standard,
Expanded Uncertainty of
Parameter / Equipment Range Method and/or
Measurement2 (+/-)
Equipment
Internal Procedure # MC-
Centrifugal Rotational
(500 to 4000) RPM 2.1 RPM DT-I-033 using Optical
Velocity
Tachometer
Cardiac Rate/
Electrocardiograms (ECG) (40 to 180) BPM 0.82 BPM Internal Procedure MC-
Monitoring Devices DT-I-003 using Fluke
Cardiac Rate/ Biomedical Patient Vital
(40 to 80) BPM 0.65 BPM
Electrocardiograms (ECG) Signs Simulators
(80 to 120) BPM 1.5 BPM
Records
Fetal Cardiac Rate/ Internal Procedure MC-
Fetal Doppler and Fetal (90 to 120) BPM 0.86 BPM DT-I-029 using Fluke PS
Monitoring Devices 320 Fetal Simulator
Internal Procedure MC-
Respiration Rate/ DT-I-039 using Fluke
(20 to 60) BrPM 0.82 BrPM
Monitoring Devices Biomedical Patient Vital
Signs Simulators
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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-1948.
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