Flammability and Medical Applications

Are your cameras tested for flammability for use in medical applications?

The Imaging Source's cameras are designed and qualified as industrial machine vision products and comply with the applicable CE and FCC requirements. Flammability testing or certification of the complete camera is not part of the standard conformity assessment for our industrial cameras.

Our camera housings are made of metal rather than plastic, which significantly reduces the potential fire hazard associated with the enclosure material.

Can your cameras be used in medical equipment?

Our cameras can be integrated into medical or laboratory equipment; however, the camera itself is not certified as a medical device.

When our camera is integrated into a medical device or laboratory system, the manufacturer of the complete system is responsible for ensuring compliance with all standards and regulatory requirements applicable to the final product.

Depending on the application, these may include, for example:

• IEC 60601-1 - Medical electrical equipment - General requirements for basic safety and essential performance

• IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use

• Applicable requirements of the IEC 60695 series concerning fire hazard testing

The applicable requirements depend on the intended use, system architecture, and classification of the final product.

Do you provide flammability certificates for your cameras?

We do not provide a flammability certificate for the complete camera as a standard product document. Such certification is not part of the standard conformity assessment of our industrial machine vision cameras.

If specific material or component information is required for the safety assessment of a customer's system, we can review the request and provide available technical information where appropriate.

Who is responsible for the flammability assessment of a medical system?

The manufacturer of the final medical or laboratory equipment is responsible for assessing and demonstrating compliance of the complete system with the applicable safety standards and regulatory requirements.

This assessment may include the evaluation of all components integrated into the system, including cameras, cables, connectors, power supplies, and other assemblies.

We therefore recommend that customers define the applicable requirements based on the relevant product standard and their intended application before specifying additional tests or certificates for individual components.

Please contact us if you have specific compliance requirements for your application. We will be happy to assess what technical documentation is available for the camera and its components.