Standards and labels

• ISO 13485:2016

  Medical devices with the ISO 13485:2016 rating are tested for a quality management system that ensures consistent safety, quality, and regulatory compliance throughout their lifecycle. This provides assurance that the product is reliably produced to high international standards for patient use.

  Test results

  Medical Management Passed

  This product was made under a quality management system that ensures consistent design, production, and distribution. This focuses on the safety, performance, and regulatory compliance of medical devices throughout their entire lifecycle, from design to disposal.

• EN 14126

  Protective clothing with the EN 14126 rating is tested for its resistance to penetration by infectious agents like bacteria and viruses from contaminated liquids, aerosols, and solid particles. This ensures the clothing provides a reliable barrier against biological hazards, helping to protect you from exposure in environments with infection risks.

  Reach out to ask about the standard test results

• EN ISO 22610:2006

  Surgical drapes, gowns, and clean air suits with the EN ISO 22610:2006 rating are tested for their resistance to wet bacterial penetration. This means the material prevents bacteria carried in liquids from passing through, even when rubbed, helping to protect patients and medical staff from infection during procedures.

  Reach out to ask about the standard test results

• EN ISO 22612:2005

  Protective clothing like surgical gowns, masks, and coveralls with the EN ISO 22612:2005 rating are tested for resistance to penetration by dry bacteria-carrying particles. This ensures the material helps protect you from airborne germs and infectious agents, reducing exposure risk in various environments.

  Reach out to ask about the standard test results