CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,

Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 1 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

Permanent Facility
MEDICAL
DEVICES- Using Gas Flow
Anesthesia Machine
1 DISCHARGE analyzer by 10 psi to 80 psi 1.11 psi
-PRESSURE
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Vital Sign
10 mmHg to 290
2 DISCHARGE BP Apparatus Simulator by 3.55 mmHg
mmHg
EQUIPMENT/DE Comparison method
VICES
Electrical Safety -
Protective Earth-
MEDICAL
Suction
DEVICES- Using Electrical
Pump,Nebulizer,Syri 0.01 ohm to 0.04
3 DISCHARGE Safety Analyzer by 0.2 Ohm to 1.8 Ohm
ng Pump,Infusion ohm
EQUIPMENT/DE Direct method
Pump, CPAP, BIPAP,
VICES
Anesthesia Machine,
Pulse Oxymeter
Electrical Safety
Analyze-Mains
MEDICAL
Voltage-Suction
DEVICES- Using Electrical
Pump,Nebulizer,Syri
4 DISCHARGE Safety Analyzer by 10 V to 240 V 7.4 % to 2.3 %
ng Pump,Infusion
EQUIPMENT/DE Direct method
Pump, CPAP, BIPAP,
VICES
Anesthesia Machine,
Pulse Oxymeter

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 2 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

Electrical Safety-
Insulation
MEDICAL
Resistance-Suction
DEVICES- Using Electrical
Pump,Nebulizer,Syri 10 MegaOhm to 100 0.24 Mohm to 8.77
5 DISCHARGE Safety Analyzer by
ng Pump,Infusion MegaOhm Mohm
EQUIPMENT/DE Direct method
Pump, CPAP, BIPAP,
VICES
Anesthesia Machine,
Pulse Oxymeter
Electrical Safety-
Leakage
MEDICAL Current(Paitent,Encl,
DEVICES- Earth)-Suction Using Electrical
6 DISCHARGE Pump,Nebulizer,Syri Safety Analyzer by 10 µA to 10000 µA 11.6 %
EQUIPMENT/DE ng Pump,Infusion Direct method
VICES Pump, CPAP, BIPAP,
Anesthesia Machine,
Pulse Oxymeter
MEDICAL
DEVICES- Using Gas Flow
FIO2 - Anesthesia
7 DISCHARGE analyzer by 21 % to 100 % 0.78 % to 1.68 %
Machine
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Flow - Boyles
8 DISCHARGE analyzer by 1 lpm to 30 lpm 0.08 lpm to 1.2 lpm
Apparatus
EQUIPMENT/DE Comparison method
VICES

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 3 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES- Using Gas Flow
Flow - Flow meter
9 DISCHARGE analyzer by 1 lpm to 30 lpm 0.08 lpm to 1 lpm
with Humidifier
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
10 ml/hr to 999 0.15 ml/hr to 12.64
10 DISCHARGE Flow - Infusion Pump device analyzer by
ml/hr ml/hr
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
10 ml/hr to 999 0.18 ml/hr to 12.66
11 DISCHARGE Flow - Syringe Pump device analyzer by
ml/hr ml/hr
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
12 DISCHARGE Flow- Nebulizer analyzer by 1 lpm to 11 lpm 0.30 lpm to 0.57 lpm
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Occlusion Pressure -
13 DISCHARGE device analyzer by 0 psi to 21 psi 0.71 psi
Infusion Pump
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Occlusion Pressure -
14 DISCHARGE device analyzer by 0 psi to 21 psi 0.71 psi
Syringe Pump
EQUIPMENT/DE Comparison method
VICES

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 4 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES- Using Gas Flow
15 DISCHARGE Pressure - CPAP analyzer by 1 mbar to 10 mbar 0.16 mbar
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Pressure(IPAP/EPAP)
16 DISCHARGE analyzer by 1 mbar to 10 mbar 0.16 mbar
- BiPAP
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Pressure- Boyles
17 DISCHARGE analyzer by 10 psi to 80 psi 1.11 psi
Apparatus
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Pressure- Oxygen
18 DISCHARGE analyzer by 10 psi to 80 psi 1.11 psi
Cylinder
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Vital Sign
Pulse Rate - Pulse
19 DISCHARGE Simulator by 30 bpm to 240 bpm 1%
Oxymeter
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Respiration Rate - 30 brpm to 240 0.8 brpm to 9.1
20 DISCHARGE analyzer by
BiPAP brpm brpm
EQUIPMENT/DE Comparison method
VICES

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 5 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES- Using Gas Flow
Respiratory Rate - 30 brpm to 240 0.8 brpm to 9.1
21 DISCHARGE analyzer by
Anesthesia Machine brpm brpm
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using SPO2 analyzer
SPO2 - Pulse
22 DISCHARGE by comparison 80 % to 100 % 1%
Oxymeter
EQUIPMENT/DE method
VICES
MEDICAL
DEVICES- Using Gas Flow
Suction Pump -
23 DISCHARGE analyzer by 0 psi to 12 psi 1%
Vacuum
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Volume - Syringe
24 DISCHARGE device analyzer by 5 ml to 400 ml 0.20 ml to 9.31 ml
Pump
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Volume- Infusion
25 DISCHARGE device analyzer by 5 ml to 400 ml 0.71 ml
Pump
EQUIPMENT/DE Comparison method
VICES
MEDICAL
Using Vital Sign
DEVICES-
26 ECG Output - ECG patient simulator by 0.48 mV to 2.24 mV 0.12 mV to 0.30 mV
IMAGING/PLOT
Comaprison method
TERS

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 6 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL Electrical Safety -

Using Electrical
DEVICES- Insulation 10 MOhm to 100 0.24 Mohm to 8.77
27 Safety Analyzer by
IMAGING/PLOT Resistance - Medical MOhm Mohm
Direct method
TERS Devices
MEDICAL
Electrical Safety - Using Electrical
DEVICES- 0.01 ohm to 0.04
28 Protective Earth - Safety Analyzer by 0.2 Ohm to 1.8 Ohm
IMAGING/PLOT ohm
Medical Devices Direct method
TERS
Electrical Safety-
MEDICAL
Leakage Using Electrical
DEVICES-
29 Current(Patient, Safety Analyzer by 10 µA to 10000 µA 11.6 %
IMAGING/PLOT
Encl, Earth) - Direct method
TERS
Medical Devices
MEDICAL
Using Vital Sign
DEVICES- 0.68 bpm to 2.96
30 Heart Rate - ECG Simulator by 30 bpm to 300 bpm
IMAGING/PLOT bpm
Comparison method
TERS
MEDICAL
Using SPO2 analyzer
DEVICES- -Spo2 - Patient
31 by comparison 80% to 100% 1%
MONITORING Monitors
method
UNIT
MEDICAL
Using Vital Sign
DEVICES- Heart Rate - Patient
32 Simulator by 30 bpm to 300 bpm 1.36 bpm
MONITORING Monitors
Comparison method
UNIT
MEDICAL
Using Vital Sign
DEVICES- IBP - Patient 30 mmHg to 250
33 Simulator by 1.96 mmHg
MONITORING Monitors mmHg
Comparison method
UNIT

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 7 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
Using Vital Sign
DEVICES- NIBP - Patient 50 mmHg to 390
34 patient simulator by 3.05 mmHg
MONITORING Monitors mmHg
Comaprison method
UNIT
MEDICAL
Using SPO2 analyzer
DEVICES- PULSE RATE-Patient
35 by comparison 30 BrPM to 240 BrPM 1.63 BrPM
MONITORING Monitors
method
UNIT
MEDICAL
DEVICES-
Using Defibrillator
PATIENT Charge Time -
36 analyzer by 1.8 s to 7.5 s 0.3 s to 0.25 s
CONDITIONING Defibrilator
Comparison method
/
MAINTENANCE
Electrical Safety -
Insulation
MEDICAL
Resistance-
DEVICES-
Autoclave, Using Electrical
PATIENT 10 MegaOhm to 100 0.24 Mohm to 8.77
37 Defibrillator,Ventilat Safety Analyzer by
CONDITIONING MegOhm Mohm
or, Electronic Direct method
/
Tourniquet, OT
MAINTENANCE
Table, Electronic/
Mechanical Bed
Electrical Safety -
MEDICAL Protective Earth-
DEVICES- Autoclave,
Using Electrical
PATIENT Defibrillator,Ventilat 0.01 ohm to 0.04
38 Safety Analyzer by 0.2 Ohm to 1.8 Ohm
CONDITIONING or, Electronic ohm
Direct method
/ Tourniquet, OT
MAINTENANCE Table, Electronic/
Mechanical Bed

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 8 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

Electrical Safety-
MEDICAL Mains Voltage -
DEVICES- Autoclave,
Using Electrical
PATIENT Defibrillator,Ventilat
39 Safety Analyzer by 10 V to 240 V 7.4 % to 2.3 %
CONDITIONING or, Electronic
Direct method
/ Tourniquet, OT
MAINTENANCE Table, Electronic/
Mechanical Bed
MEDICAL
DEVICES-
Using Defibrillator
PATIENT
40 Energy - Defibrilator analyzer by 10.50 J to 300 J 0.68 J to 3.75 J
CONDITIONING
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT
41 FIO2 - Ventilator analyzer by 21% to 100% 0.78 % to 1.68 %
CONDITIONING
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT
42 Flow - Ventilator analyzer by 1 LPM to 80 LPM 0.08 lpm to 1.11 lpm
CONDITIONING
Comparison method
/
MAINTENANCE

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 9 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES-
Using Defibrillator
PATIENT Heart Rate -
43 analyzer by 30 BPM to 300 BPM 0.76 bpm to 9.1 bpm
CONDITIONING Defibrillator
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT Pressure (PEEP,
44 analyzer by 1 mbar to 10 mbar 0.16 mbar
CONDITIONING PIP,MAP) - Ventilator
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Vital Sign
PATIENT Pressure - Electronic 50 mmHg to 360
45 Simulator by 4.47 mmHg
CONDITIONING Tourniquet mmHg
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT Respiration Rate - 30 brpm to 240 0.8 brpm to 3.8
46 analyzer by
CONDITIONING Ventilator brpm brpm
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Volume (Tidal Using Gas Flow
PATIENT
47 Volume, Minute analyzer by 0.22 ltr to 25 ltr 0.02 ltr to 0.7 ltr
CONDITIONING
Volume) - Ventilator Comparison method
/
MAINTENANCE

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 10 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

Site Facility
MEDICAL
DEVICES- Using Gas Flow
Anesthesia Machine
1 DISCHARGE analyzer by 10 psi to 80 psi 1.11 psi
-PRESSURE
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Vital Sign
10 mmHg to 290
2 DISCHARGE BP Apparatus Simulator by 3.55 mmHg
mmHg
EQUIPMENT/DE Comparison method
VICES
Electrical Safety -
Protective Earth-
MEDICAL
Suction
DEVICES- Using Electrical
Pump,Nebulizer,Syri 0.01 ohm to 0.04
3 DISCHARGE Safety Analyzer by 0.2 Ohm to 1.8 Ohm
ng Pump,Infusion ohm
EQUIPMENT/DE Direct method
Pump, CPAP, BIPAP,
VICES
Anesthesia Machine,
Pulse Oxymeter
Electrical Safety
Analyze-Mains
MEDICAL
Voltage-Suction
DEVICES- Using Electrical
Pump,Nebulizer,Syri
4 DISCHARGE Safety Analyzer by 10 V to 240 V 7.4 % to 2.3 %
ng Pump,Infusion
EQUIPMENT/DE Direct method
Pump, CPAP, BIPAP,
VICES
Anesthesia Machine,
Pulse Oxymeter

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 11 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

Electrical Safety-
Insulation
MEDICAL
Resistance-Suction
DEVICES- Using Electrical
Pump,Nebulizer,Syri 10 MegaOhm to 100 0.24 Mohm to 8.77
5 DISCHARGE Safety Analyzer by
ng Pump,Infusion MegaOhm Mohm
EQUIPMENT/DE Direct method
Pump, CPAP, BIPAP,
VICES
Anesthesia Machine,
Pulse Oxymeter
Electrical Safety-
Leakage
MEDICAL Current(Paitent,Encl,
DEVICES- Earth)-Suction Using Electrical
6 DISCHARGE Pump,Nebulizer,Syri Safety Analyzer by 10 µA to 10000 µA 11.6 %
EQUIPMENT/DE ng Pump,Infusion Direct method
VICES Pump, CPAP, BIPAP,
Anesthesia Machine,
Pulse Oxymeter
MEDICAL
DEVICES- Using Gas Flow
FIO2 - Anesthesia
7 DISCHARGE analyzer by 21 % to 100 % 0.78 % to 1.68 %
Machine
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Flow - Boyles
8 DISCHARGE analyzer by 1 lpm to 30 lpm 0.08 lpm to 1.2 lpm
Apparatus
EQUIPMENT/DE Comparison method
VICES

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 12 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES- Using Gas Flow
Flow - Flow meter
9 DISCHARGE analyzer by 1 lpm to 30 lpm 0.08 lpm to 1 lpm
with Humidifier
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
10 ml/hr to 999 0.15 ml/hr to 12.64
10 DISCHARGE Flow - Infusion Pump device analyzer by
ml/hr ml/hr
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
10 ml/hr to 999 0.18 ml/hr to 12.66
11 DISCHARGE Flow - Syringe Pump device analyzer by
ml/hr ml/hr
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
12 DISCHARGE Flow- Nebulizer analyzer by 1 lpm to 11 lpm 0.30 lpm to 0.57 lpm
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Occlusion Pressure -
13 DISCHARGE device analyzer by 0 psi to 21 psi 0.71 psi
Infusion Pump
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Occlusion Pressure -
14 DISCHARGE device analyzer by 0 psi to 21 psi 0.71 psi
Syringe Pump
EQUIPMENT/DE Comparison method
VICES

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 13 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES- Using Gas Flow
15 DISCHARGE Pressure - CPAP analyzer by 1 mbar to 10 mbar 0.16 mbar
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Pressure(IPAP/EPAP)
16 DISCHARGE analyzer by 1 mbar to 10 mbar 0.16 mbar
- BiPAP
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Pressure- Boyles
17 DISCHARGE analyzer by 10 psi to 80 psi 1.11 psi
Apparatus
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Pressure- Oxygen
18 DISCHARGE analyzer by 10 psi to 80 psi 1.11 psi
Cylinder
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Vital Sign
Pulse Rate - Pulse
19 DISCHARGE Simulator by 30 bpm to 240 bpm 1%
Oxymeter
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Gas Flow
Respiration Rate - 30 brpm to 240 0.8 brpm to 9.1
20 DISCHARGE analyzer by
BiPAP brpm brpm
EQUIPMENT/DE Comparison method
VICES

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 14 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES- Using Gas Flow
Respiratory Rate - 30 brpm to 240 0.8 brpm to 9.1
21 DISCHARGE analyzer by
Anesthesia Machine brpm brpm
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using SPO2 analyzer
SPO2 - Pulse
22 DISCHARGE by comparison 80 % to 100 % 1%
Oxymeter
EQUIPMENT/DE method
VICES
MEDICAL
DEVICES- Using Gas Flow
Suction Pump -
23 DISCHARGE analyzer by 0 psi to 12 psi 1%
Vacuum
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Volume - Syringe
24 DISCHARGE device analyzer by 5 ml to 400 ml 0.20 ml to 9.31 ml
Pump
EQUIPMENT/DE Comparison method
VICES
MEDICAL
DEVICES- Using Infusion
Volume- Infusion
25 DISCHARGE device analyzer by 5 ml to 400 ml 0.71 ml
Pump
EQUIPMENT/DE Comparison method
VICES
MEDICAL
Using Vital Sign
DEVICES-
26 ECG Output - ECG patient simulator by 0.48 mV to 2.24 mV 0.12 mV to 0.30 mV
IMAGING/PLOT
Comaprison method
TERS

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 15 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL Electrical Safety -

Using Electrical
DEVICES- Insulation 10 MOhm to 100 0.24 Mohm to 8.77
27 Safety Analyzer by
IMAGING/PLOT Resistance - Medical MOhm Mohm
Direct method
TERS Devices
MEDICAL
Electrical Safety - Using Electrical
DEVICES- 0.01 ohm to 0.04
28 Protective Earth - Safety Analyzer by 0.2 Ohm to 1.8 Ohm
IMAGING/PLOT ohm
Medical Devices Direct method
TERS
Electrical Safety-
MEDICAL
Leakage Using Electrical
DEVICES-
29 Current(Patient, Safety Analyzer by 10 µA to 10000 µA 11.6 %
IMAGING/PLOT
Encl, Earth) - Direct method
TERS
Medical Devices
MEDICAL
Using Vital Sign
DEVICES- 0.68 bpm to 2.96
30 Heart Rate - ECG Simulator by 30 bpm to 300 bpm
IMAGING/PLOT bpm
Comparison method
TERS
MEDICAL
Using SPO2 analyzer
DEVICES- -Spo2 - Patient
31 by comparison 80% to 100% 1%
MONITORING Monitors
method
UNIT
MEDICAL
Using Vital Sign
DEVICES- Heart Rate - Patient
32 Simulator by 30 bpm to 300 bpm 1.36 bpm
MONITORING Monitors
Comparison method
UNIT
MEDICAL
Using Vital Sign
DEVICES- IBP - Patient 30 mmHg to 250
33 Simulator by 1.96 mmHg
MONITORING Monitors mmHg
Comparison method
UNIT

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 16 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
Using Vital Sign
DEVICES- NIBP - Patient 50 mmHg to 390
34 patient simulator by 3.05 mmHg
MONITORING Monitors mmHg
Comaprison method
UNIT
MEDICAL
Using SPO2 analyzer
DEVICES- PULSE RATE-Patient
35 by comparison 30 BrPM to 240 BrPM 1.63 BrPM
MONITORING Monitors
method
UNIT
MEDICAL
DEVICES-
Using Defibrillator
PATIENT Charge Time -
36 analyzer by 1.8 s to 7.5 s 0.3 s to 0.25 s
CONDITIONING Defibrilator
Comparison method
/
MAINTENANCE
Electrical Safety -
Insulation
MEDICAL
Resistance-
DEVICES-
Autoclave, Using Electrical
PATIENT 10 MegaOhm to 100 0.24 Mohm to 8.77
37 Defibrillator,Ventilat Safety Analyzer by
CONDITIONING MegOhm Mohm
or, Electronic Direct method
/
Tourniquet, OT
MAINTENANCE
Table, Electronic/
Mechanical Bed
Electrical Safety -
MEDICAL Protective Earth-
DEVICES- Autoclave,
Using Electrical
PATIENT Defibrillator,Ventilat 0.01 ohm to 0.04
38 Safety Analyzer by 0.2 Ohm to 1.8 Ohm
CONDITIONING or, Electronic ohm
Direct method
/ Tourniquet, OT
MAINTENANCE Table, Electronic/
Mechanical Bed

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 17 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

Electrical Safety-
MEDICAL Mains Voltage -
DEVICES- Autoclave,
Using Electrical
PATIENT Defibrillator,Ventilat
39 Safety Analyzer by 10 V to 240 V 7.4 % to 2.3 %
CONDITIONING or, Electronic
Direct method
/ Tourniquet, OT
MAINTENANCE Table, Electronic/
Mechanical Bed
MEDICAL
DEVICES-
Using Defibrillator
PATIENT
40 Energy - Defibrilator analyzer by 10.50 J to 300 J 0.68 J to 3.75 J
CONDITIONING
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT
41 FIO2 - Ventilator analyzer by 21% to 100% 0.78 % to 1.68 %
CONDITIONING
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT
42 Flow - Ventilator analyzer by 1 LPM to 80 LPM 0.08 lpm to 1.11 lpm
CONDITIONING
Comparison method
/
MAINTENANCE

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 18 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

Measurand or Reference
Measurement range and
Material/Type of instrument * Calibration and
Calibration or Measurement additional parameters
S.No Discipline / Group or material to be calibrated Measurement
Method or procedure where applicable(Range
or measured / Quantity Capability(CMC)(±)
and Frequency)
Measured /Instrument

MEDICAL
DEVICES-
Using Defibrillator
PATIENT Heart Rate -
43 analyzer by 30 BPM to 300 BPM 0.76 bpm to 9.1 bpm
CONDITIONING Defibrillator
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT Pressure (PEEP,
44 analyzer by 1 mbar to 10 mbar 0.16 mbar
CONDITIONING PIP,MAP) - Ventilator
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Vital Sign
PATIENT Pressure - Electronic 50 mmHg to 360
45 Simulator by 4.47 mmHg
CONDITIONING Tourniquet mmHg
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Using Gas Flow
PATIENT Respiration Rate - 30 brpm to 240 0.8 brpm to 3.8
46 analyzer by
CONDITIONING Ventilator brpm brpm
Comparison method
/
MAINTENANCE
MEDICAL
DEVICES-
Volume (Tidal Using Gas Flow
PATIENT
47 Volume, Minute analyzer by 0.22 ltr to 25 ltr 0.02 ltr to 0.7 ltr
CONDITIONING
Volume) - Ventilator Comparison method
/
MAINTENANCE

This is annexure to 'Certificate of Accreditation' and does not require any signature.
 CRITISURE MEDITECH, B 310, WING B, THE ONE WORLD, 150 FT RING ROAD,
Laboratory Name :
RAJKOT, GUJARAT, INDIA
Accreditation Standard ISO/IEC 17025:2017
Certificate Number CC-4008 Page No 19 of 19
Validity 01/08/2024 to 08/11/2024 Last Amended on -

* CMCs represent expanded uncertainties expressed at approximately the 95% level of confidence, using a coverage factor of k = 2.

This is annexure to 'Certificate of Accreditation' and does not require any signature.