NABL Accredited · CC-2480 · Est. 2004 · Gujarat's Trusted Calibration Lab
NABL-accredited calibration for all ECG machine types — 12-lead systems, simulators, heart rate testers, and electrode impedance checks. IEC 60601-2-51 traceable, accepted by NABH, WHO GMP, and all hospital quality auditors.
±5 mV
Range
±2%
Accuracy
IEC 60601-2-51
Standard
IEC 60601-2-51
ECG Machine Standard
NABL Accredited
CC-2480
— WHAT IS ECG MACHINE CALIBRATION —
Imagine a cardiologist reading an ECG where the ST segment appears 0.5 mm elevated — enough to suggest myocardial ischaemia — but the elevation is an artefact of an uncalibrated machine. Conversely, a real 1 mm elevation could appear as 0.7 mm on a machine with gain error, leading to a missed diagnosis. ECG accuracy is not an abstract requirement — it is a clinical necessity.
ECG machine calibration involves verifying signal amplitude accuracy across all 12 leads, checking paper speed, heart rate measurement accuracy, and frequency response. Any deviations are documented and corrected, resulting in a NABL certificate confirming compliance with IEC 60601-2-51 — the international standard for ECG machine performance.
Verify
Amplitude, speed, HR and frequency response tested across all 12 leads.
Correct
Gain adjustment and correction factors applied where required by manufacturer.
Certify
NABL CC-2480 certificate issued — accepted by NABH, WHO GMP, and FDA auditors.
— INSTRUMENTS COVERED —
12-lead systems, ECG simulators, heart rate testers, and electrode impedance checks — all calibrated per IEC 60601-2-51.
Full 12-lead ECG machine calibration verifying amplitude accuracy, frequency response, and timing across all leads.
ECG patient simulators calibrated for waveform amplitude, heart rate accuracy, and arrhythmia pattern generation.
Heart rate measurement accuracy verified at multiple rates against calibrated reference frequency sources.
Electrode connection quality and patient input impedance verification per IEC 60601-2-51 requirements.
— OUR PROCESS —
ECG machine received and tagged. Physical inspection — lead cables, electrode connections, paper feed, and display function documented as-found.
Internal 1 mV calibration pulse amplitude and timing verified against calibrated reference. Paper speed accuracy tested at 25 and 50 mm/s.
Signal amplitude accuracy measured at 0.5, 1, 2, and 5 mV inputs across all 12 leads using calibrated ECG simulator. Deviations recorded.
Frequency response from 0.05 to 150 Hz verified. Heart rate accuracy tested at 30, 60, 80, 120, and 200 BPM.
Post-calibration amplitude and heart rate re-measured at all calibration points. Expanded uncertainty calculated per ISO/IEC 17025.
NABL CC-2480 certificate issued with amplitude data, HR accuracy, frequency response, and IEC 60601-2-51 traceability.
— STANDARDS & COMPLIANCE —
Every ECG machine calibration follows IEC 60601-2-51 with full traceability to NPL national electrical standards. Our certificates satisfy NABH, WHO GMP, FDA, and all cardiology audit requirements.
ISO/IEC 17025
NABL Accreditation Standard
IEC 60601-2-51
ECG Machine Standard
IEC 60601-1
Medical Equipment Safety
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.
