Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Using IEC 60601-1-9 to Your Advantage
Environmentally conscious design is an overall good practice for the medical device industry. In order to make claims of sustainability, some countries require verification. Other countries, like Brazil, are moving toward requirements for improving the environmental impact of medical electrical devices. One standard can provide the guidance for manufacturers: IEC 60601-1-9
IEC 60601-1-9 is based on practical experiences from the industry. The objective of the standard is the improvement of environmental impact, taking into account all stages of a product's life cycle, from initial specification to end-of-life management. It does not provide a simple list of eco-friendly design specifications, but assessment checks based on verifying procedures are in place and evidence is documented to illustrate that environmentally friendly principles were included in the design and development process. The end goal is to minimize significant impact on the environment.
The core requirements of IEC 60601-1-9 can be summed up as "identification," "instruction," and "end-of-life management." In order to demonstrate compliance to IEC 60601-1-9, the following must be submitted: design documents and process descriptions, packaging information, documents on minimizing environmental impact and information related to end-of-life management. Assessments can be done independently from the evaluations of the other parts of the IEC 60601 series. A manufacturer can also use risk analysis to help decide on environmental improvement targets, although this is not required.
The benefits of eco-conscious design in medical electrical equipment can be great, fulfilling requirements or simply indicating a product fills an eco-friendly demand. Using IEC 60601-1-9 as a guide can help support sustainability claims and allow manufacturers to bring greener medical devices to the market. For more insights on how to use IEC 60601-1-9 in designing and developing eco-friendly medical devices, download a copy of our free white paper.
Michael Brousseau is the U.S. Technical Lead for Intertek's Medical business line. In nearly 20 years with Intertek he has worked with electrical manufacturers across a wide range of industries – including medical, IT, industrial, lighting, and more – to meet regulatory, industry, and market requirements around the world.