IEC/EN 60601-1-9 Sustainable Medical Devices Test Standard

This standard is based on practical industry experience demonstrating requirements, cost savings and marketing benefits. While not a requirement for many countries and certification programs, if a manufacturer wishes to make sustainability claims about their products, they are legally required to provide verifiable data to support their claims, given the importance of such products to the industry.

The aim of IEC/EN 60601-1-9 is to improve environmental impact by considering all phases of a product's entire life cycle, from initial specification to end-of-life management. While it does not provide a simple list of eco-design specifications, the conformity assessment controls outlined in the standard are based on verifying that procedures exist and documented evidence of how eco-friendly principles are incorporated into the design and development process. The ultimate goal is to minimize the significant impact on the environment.

This standard addresses the environmental impact of medical devices, taking into account factors such as emissions of toxic materials and biological and chemical hazards. Evaluating results at each stage of the activity provides valuable input to the risk management process.

To demonstrate compliance with IEC/EN 60601-1-9, the following must be submitted:

• Design documents and process description for defining environmental aspects and information from the supply chain
• Design documents related to the reduction of negative environmental impacts
• Information about packaging
• Accompanying documents; sections on minimizing environmental impact during normal use
• Information on end-of-life management

The acceptability of the environmental impacts of medical electrical equipment is balanced against other factors. Intended function, performance, safety, cost, marketability, quality, and legal and regulatory requirements. The balance may differ depending on the intended use of the device. For a device intended to correct a minor ailment, a life-saving or life-support equipment-friendly solution may not be suitable. This means that the manufacturer must also be prepared to verify that the medical benefit outweighs the associated adverse environmental effects.

EUROLAB assists manufacturers with IEC/EN 60601-1-9 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories.