SIQ Accredited for Testing Surgical and Diagnostic Lamps under IEC 60601-2-41

SIQ is an internationally accredited testing laboratory for conformity assessment according to the standard IEC 60601-2-41 — Particular requirements for the basic safety and essential performance of surgical and diagnostic lamps. All testing is performed in-house, in our dedicated laboratory, fully equipped to carry out the complete range of evaluations required by the standard.

Types of Lamps Covered by the Standard

IEC 60601-2-41 distinguishes between two main types of lamps, each with its own testing scope:

• Surgical lamps – used during surgical procedures
• Diagnostic lamps – used during diagnostic examinations

Ensuring Long-Term Performance and Usability

For surgical lamps, it is especially important that the light quality and performance remain stable even after prolonged use over many hours, days, or years. Critical parameters, such as Ra (Colour Rendering Index) and CRI (Colour Rendering Index), play a key role in enabling the surgeon to clearly distinguish tissue and organ colours during procedures — supporting accuracy, safety, and optimal outcomes.

However, compliance with the standard extends beyond technical parameters alone. The usability of the lamp in real-world conditions is equally essential. To address this, SIQ incorporates realistic simulations of operating room conditions, including potential obstacles, such as the presence of medical staff in the light path.

Obstacle Simulation Testing

We assess lamp performance under conditions that simulate real-world obstructions:

-Operator Obstruction Simulation

Operator obstruction is simulated using a 210 mm diameter mask to represent the surgeon’s head. The “surgeon’s head” is modelled as a black-painted metal disc, with a thickness of no more than 2 mm and a diameter of 210 mm. This mask is positioned 600 mm from the sensor and 400 mm from the light source, assuming a reference distance (D_ref) of 1000 mm. D_ref refers to the standard distance at which most measurements are performed.

There are two different approaches to these measurements:

1. Single-mask setup: A single mask is placed at the centre of the light source.
2. Dual-mask setup: Two masks are used instead of one.

Why use two masks?
The answer is simple—during complex surgical procedures, the surgeon is often accompanied by assistants who may also obstruct the light and cast shadows on the patient’s body. Therefore, the dual-mask setup simulates a more realistic scenario.

Measurement Procedure:

The measurements are carried out in four stages:

1. Place both masks in a horizontal position with a 50 mm gap between them.
2. Rotate both masks evenly by 45°.
3. (You may want to include the remaining stages here if applicable.)

-Simulated Cavity Testing

In addition to obstacle testing, we also evaluate illumination in combination with simulated cavities, designed to represent hard-to-reach internal areas of the body. These tests ensure that the lamp can provide sufficient and consistent illumination, even in confined or obstructed surgical fields — which is vital for reducing the risk of error.

More information:
Janez Vidmar
E-mail: janez.vidmar@siq.si
Tel.: +386 1 4778 256