Prism Calibration Centre
NABL Accredited · CC-2480

SpO2 Simulators
Calibration
Services

NABL-accredited calibration for SpO2 simulators, pulse oximeter testers, and patient simulators. IEC 60601-2-61 compliant. Accepted by NABH, WHO GMP, and FDA auditors across Gujarat.

IEC 60601-2-61SpO2 Standard
Range: 70–100% SpO2Accuracy: ±1%Standard: IEC 60601-2-61
NABL CC-2480IEC 60601-2-61ISO/IEC 17025:201770–100% SpO2±1% AccuracyNABH AcceptedWHO GMPOnsite Gujarat4 SpO2 Types
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Instruments Calibrated
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— WHAT IS IT —

What is SpO2 Simulator Calibration?

SpO2 simulator calibration verifies that the optical reference signals generated by a pulse oximeter simulator accurately represent the intended blood oxygen saturation levels and pulse rates across the full clinical range.

IEC 60601-2-61 and NABH biomedical standards require documented calibration of all SpO2 test equipment used to verify pulse oximeters in clinical settings.

Prism's NABL CC-2480 calibration covers optical signal accuracy, SpO2 level accuracy at 5+ saturation points, and pulse rate accuracy at multiple BPM settings.

Why Calibration Matters

A miscalibrated simulator gives false confidence in oximeter accuracy
Undetected SpO2 errors in ICUs can lead to missed hypoxia events
IEC 60601-2-61 mandates traceable calibration of all SpO2 test equipment
NABH requires documented calibration of biomedical test instruments annually
Pulse rate errors cascade into arrhythmia detection failures

— INSTRUMENTS COVERED —

SpO2 Equipment We Calibrate

01

Pulse Oximeter Simulator

Functional SpO2 simulators generating optical reference signals for verifying pulse oximeter SpO2 and pulse rate readings.

70–100% SpO2Res: ±1%IEC 60601-2-61
02

SpO2 / PR Tester

Combined SpO2 and pulse rate accuracy testers calibrated for signal level, modulation ratio, and timing accuracy.

70–100% SpO2Res: ±1%IEC 60601-2-61
03

Functional Patient Simulator

Multi-parameter patient simulators with SpO2 channel calibrated for optical signal accuracy across the full saturation range.

70–100% SpO2Res: ±1%IEC 60601-2-61
04

SpO2 Probe Verification

Probe performance testers verifying optical transmission, wavelength accuracy, and probe-device interface integrity.

70–100% SpO2Res: ±1%IEC 60601-2-61

— OUR PROCESS —

Calibration Process — Step by Step

01

Intake & Condition Check

SpO2 simulator received and tagged. Physical inspection — probe connector condition, display, battery, and optical output verified as-found.

02

Optical Signal Calibration

Optical signal amplitude and modulation ratio calibrated at reference saturation levels using NPL-traceable optical power references.

03

SpO2 Accuracy Verification

Simulator output verified at 5+ saturation levels (70%, 80%, 90%, 95%, 100%) — deviation from target SpO2 recorded at each point.

04

Pulse Rate Accuracy Test

Pulse rate output accuracy measured at standard rates (30, 60, 80, 120, 250 BPM) and compared against reference frequency counter.

05

As-Left Verification

Post-calibration SpO2 and PR readings verified at all calibration points. Expanded uncertainty calculated per ISO/IEC 17025.

06

NABL Certificate Issued

NABL CC-2480 certificate issued with SpO2 accuracy, PR accuracy data, uncertainty (k=2), and IEC 60601-2-61 traceability.

— STANDARDS & COMPLIANCE —

Standards We Work To

ISO/IEC 17025
NABL Accreditation Standard
IEC 60601-2-61
SpO2 Equipment Standard
ISO 13485
Medical Device QMS
NABH
Hospital Accreditation
WHO GMP
GMP Compliance
FDA 21 CFR
US FDA Compliance
NPL / NIST
Traceable Reference
ISO 9001:2015
Quality Management

— NON-NABL OPTION —

Non-NABL Calibration Available

Not every calibration needs a NABL certificate. For internal quality checks, maintenance records, or large batch instruments, our non-NABL calibration service offers the same technical precision at a lower cost and faster turnaround.

All non-NABL calibrations use the same NPL-traceable reference standards and follow ISO/IEC 17025 methodology — only the certificate header differs.

Traceable References

All non-NABL jobs use the same NPL-traceable references — only the certificate type differs.

Faster Turnaround

Non-NABL jobs completed faster — ideal for urgent maintenance or large bulk batches.

Cost-Effective

Priced lower than NABL — right choice for internal checks and non-audit use cases.

Onsite or In-Lab

Available at our Ahmedabad lab and as onsite service across Gujarat — same team, same quality.

— SERVICE AREAS —

Onsite Calibration Across Gujarat

AhmedabadVadodaraBharuchDahejAnkleshwarSuratRajkotGandhinagarNadiadAnand

— WHY PRISM —

Why Choose Prism Calibration?

NABL CC-2480 — ILAC MRA

Accepted in 100+ countries. Recognized by FDA, GPCB, WHO GMP auditors internationally.

Fast Certificate Delivery

Same-day urgent service available. Certificates delivered digitally within 24 hours.

100% Onsite, No Downtime

Engineers travel to your facility. No instrument removal.

Triple Govt. Authorization

NABL + GPCB + BEE — one of very few Gujarat labs holding all three simultaneously.

70+ Engineers

NABL-certified field & lab specialists

Same-Day Service

Urgent certificates when you need them

Zero Rejections

Every certificate WHO GMP & FDA accepted

All Gujarat

Every GIDC zone covered onsite

ILAC MRA

Globally recognized, 100+ countries

Since 2004

20+ years of unbroken track record

— FAQ —

Frequently Asked Questions

— GET IN TOUCH —

Request a Calibration Quote

Fill in the form and our team will contact you within 2 business hours with pricing and availability for onsite or in-lab SpO2 simulator calibration.

Address
F-101, Rudraksh Complex 2, Phase 3, GIDC Vatva, Ahmedabad 382445
WhatsApp Us Now

— FROM OUR BLOG —

Related Articles & Guides

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.