NABL Accredited · CC-2480 · Est. 2004 · Gujarat's Trusted Calibration Lab
NABL-accredited calibration for multiparameter, ECG/SpO2, NIBP, and IBP waveform patient simulators. IEC 60601-1 traceable, accepted by NABH and ISO 13485 auditors.
Multi-param
Range
±1%
Accuracy
IEC 60601-1
Standard
IEC 60601-1
Patient Simulator Standard
NABL Accredited
CC-2480
— WHAT IS PATIENT SIMULATOR CALIBRATION —
Imagine a patient monitor that's verified against a simulator outputting an SpO2 signal that's itself 3% off — the monitor would "pass" testing while still being clinically inaccurate. The simulator is the reference; if it drifts, every device tested against it inherits the error.
Patient simulator calibration verifies ECG, SpO2, NIBP, and IBP waveform outputs against NPL-traceable references at multiple set points. Deviations are documented, internal coefficients adjusted, and a NABL certificate issued confirming IEC 60601-1 compliance — accepted by NABH and ISO 13485 auditors.
Check
ECG, SpO2, NIBP, and IBP outputs measured against NPL-traceable reference at multiple set points.
Correct
Internal calibration coefficients adjusted; correction table issued for fixed-output parameters.
Certify
NABL CC-2480 certificate issued with full accuracy data and uncertainty statement.
— INSTRUMENTS COVERED —
Multiparameter, ECG/SpO2, NIBP, and IBP waveform simulators across all major brands.
Comprehensive simulators (Fluke ProSim, BIOTEK MPS) calibrated for ECG, SpO2, NIBP, and temperature simultaneously.
ECG amplitude and SpO2 saturation level simulation accuracy verified using NABL-traceable reference.
Non-invasive blood pressure simulators calibrated for systolic, diastolic, and mean arterial pressure accuracy.
Invasive blood pressure waveform simulators verified for waveform shape, amplitude, and pressure accuracy.
— OUR PROCESS —
Patient simulator make, model, serial number, and all output parameters documented. Battery condition and software version noted.
ECG amplitude output (1 mV standard) measured using calibrated oscilloscope or AC signal reference. Heart rate accuracy at 40–250 bpm verified.
SpO2 simulation levels (70–100%) and NIBP simulation pressure output measured against NABL-traceable reference.
Internal calibration coefficients adjusted where permitted. Correction table issued for fixed-output parameters.
Post-adjustment outputs verified at all parameters. Expanded uncertainty calculated per ISO/IEC 17025.
NABL CC-2480 certificate with accuracy data for all simulated parameters, uncertainty (k=2), traceability issued within 24 hours.
— STANDARDS & COMPLIANCE —
Every patient simulator calibration is performed under IEC 60601-1, with full traceability to NPL national standards. Our certificates satisfy all hospital accreditation and regulatory audit requirements.
ISO/IEC 17025
NABL Accreditation Standard
IEC 60601-1
Medical Equipment Safety
IEC 60601-2-49
Patient Monitor Standard
ISO 13485
Medical Device QMS
NABH
Hospital Accreditation
WHO GMP
GMP Compliance
NPL / NIST
Traceable Reference
ISO 9001:2015
Quality Management
Prism holds NABL CC-2480 under ISO/IEC 17025:2017, recognized under the ILAC MRA agreement. Our biomedical calibration certificates are valid for WHO GMP, FDA, NABH, and all audit purposes.
— NON-NABL CALIBRATION —
For routine maintenance, bulk calibration, or facilities not needing NABL certification — Prism offers cost-effective non-NABL calibration with the same trained engineers and traceable references.
All non-NABL jobs use the same NPL-traceable references — only the certificate type differs.
Non-NABL jobs completed faster — ideal for urgent maintenance or large bulk batches.
Priced lower than NABL — right choice for internal checks and non-audit use cases.
Available at our Ahmedabad lab and as onsite service across Gujarat — same team, same quality.
— AREAS WE SERVICE —
NABL-certified engineers travel to your facility across Gujarat — hospital, pharma, or laboratory onsite service.
Why Choose Prism
Since 2004, every NABL biomedical certificate issued by Prism has been accepted by WHO GMP, FDA, NABH, and ISO auditors — no rejections, no rework.
— FAQ —
Get In Touch
Tell us what you need calibrated and whether you need onsite or in-lab service. We respond within 2 business hours.
— FROM OUR BLOG —
NABL Accreditation Disclaimer
Calibration services are provided under NABL Certificate CC-2480 in strict accordance with our officially approved scope of accreditation (ISO/IEC 17025:2017). Parameters or onsite conditions falling outside our active NABL scope are processed with standard metrological traceability to NPL/BIPM national standards.
