Honeywell medical fibers have passed ISO 13485 certification to help the high-quality development of China's medical device industry

Ultra-light and ultra-high-strength fibers have won industry management standards for safety and quality

Shanghai, China, August 25, 2021 – Honeywell (NASDAQ: HON) today announced that its Spectra® medical fiber has achieved ISO 13485 certification to manufacture and supply to the medical device industry. This lays a solid foundation for Honeywell's further development in China's medical device market. Honeywell will continue to develop products and technologies that meet customer needs and contribute to the high-quality development of China's medical device industry.

Spectra® Medical Fiber is an ultra-lightweight, ultra-high-strength fiber that can be used to produce minimally invasive surgical medical devices, giving manufacturers greater flexibility to design and build more compact, high-strength and lightweight medical devices. Compared to traditional polyethylene fibers, Spectra® medical fibers offer ultra-high molecular weight, high orientation, and crystallinity, resulting in significantly improved fiber strength and surface damage resistance. At the same volume, it is three times stronger than polyester fibers and is not resistant to chemical corrosion, water washes and UV exposure. In addition, it is highly resistant to chemicals, fatigue and abrasion, with a low coefficient of friction and smooth movement, making it an ideal biomaterial for many applications in the medical device industry.

With ISO 13485 certification, Honeywell can identify, control and mitigate risks in the production and sale of medical device raw materials and components by implementing a medical device quality management system. The certification stipulates technical conditions and standards according to the requirements of the medical device industry, thereby improving the production process and ensuring consistent quality. It also helps customers reduce the cost of non-conforming products, ensure that objective quality standards are met, and improve market competitiveness.

"Honeywell is committed to creating value for the development and production of medical devices in China. This certification means a lot to Honeywell's customers. As regulations become more stringent, this certification helps our customers manage risk and help their medical devices obtain regulatory approval," said Weiqiang Liu, vice president and general manager, Asia Pacific, Honeywell Performance Materials, "With the help of Spectra® medical fibers, medical device manufacturers can continue to develop and launch products that are more compact, efficient, stronger and lighter. ”

The International Organization for Standardization (ISO) is the world's largest international standardization body, headquartered in Geneva, Switzerland. ISO 13485 is the highest quality management system standard for the design and production of medical devices, specifying the capabilities required by manufacturers to supply medical devices and ancillary services, with a focus on the safety and effectiveness of medical devices to ensure that they consistently meet customer and regulatory requirements. Many countries have translated the ISO 13485 standard into their own standards and implemented them in the field of medical devices.

China's medical device regulatory authorities actively follow up the formulation and revision process of ISO13485 standards, and simultaneously transform the industry standards applicable to the Chinese market and align with international standards. In 2017, the State Food and Drug Administration issued and implemented the new version of YY/T0287-2017/ISO13485 "Requirements for the Use of Medical Device Quality Management System in Regulations" in accordance with the ISO13485:2016 standard to promote the healthy development of the medical device industry.

Honeywell is a leading manufacturer of fibers and films that develop and produce high-performance packaging films, high-performance fibers and composites in line with global trends. Spectra® fibers offer lighter, higher weight and performance than steel in applications such as medical devices, pharmaceutical packaging, industrial ropes and fishing lines.

Honeywell medical fibers have passed ISO 13485 certification to help the high-quality development of China's medical device industry

Honeywell medical fibers have passed ISO 13485 certification to help the high-quality development of China's medical device industry

Sections viewed

Contact

working hours