Intertek, a Total Quality Assurance provider to a range of industries worldwide, is announcing new services to help manufacturers of medical electrical equipment verify their products are environmentally conscious.
The services are an expansion of Intertek’s existing IEC 60601-1 services and consist of an engineering review of product design and development processes in line with the IEC 60601-1-9 standard on environmentally conscious design.
More than 80 percent of hospitals around the world are expected to incorporate sustainability into their purchasing decisions, according to a Harris Poll commissioned by Johnson & Johnson in 2014.1
Additionally, Brazil will mandate regulatory compliance with a number of IEC 60601-1-9 clauses beginning December 1st, emphasizing healthcare’s role in promoting eco-friendly products to encourage human and environmental health. By law, medical device companies need to provide verifiable data for claims of sustainability.
The International Electrotechnical Commission (IEC) provides a formal way of verifying eco-friendly claims with its IEC 60601-1-9 standard and using these standards, the Intertek team can help customers make important sustainability claims about their products.
"Intertek is committed to guiding its customers throughout the product design and development process to better address concerns from the global healthcare industry and regulatory agencies," said Stephanie Gruhn, Medical Global Business Lead at Intertek.
"By partnering with them throughout the process, these new services will help them navigate regulatory requirements that bring environmentally conscious products to the global market faster and more easily.
The new offering was developed in conjunction with an Intertek white paper identifying how the IEC standard can be used to promote sustainability claims. Key areas highlighted in the paper include regulatory requirements; impact on certification schemes, including the IECEE CB scheme; benefits of applying the IEC 60601-1-9 standard and how to demonstrate compliance.
For more than 50 years Intertek has been partnering with medical device manufacturers to develop global regulatory solutions for assurance, testing, inspection and certification auditing. The company’s experts understand the latest technologies and the regulatory requirements that products must meet, including those for mobile health applications and software.
With more than 80 engineers and technicians across the world dedicated to testing medical devices at 10 Centers of Excellence and 23 labs equipped with state-of-the-art equipment for electromagnetic compatibility (EMC) testing, Intertek helps customers launch new medical devices to market quickly.
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 40,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.