ISO 13485 is an international standard for medical device quality management systems, which specifies the requirements for the design, development, production, installation, and servicing of medical devices.

ISO 13485 O-rings are typically made from a variety of materials such as silicone, Viton, EPDM, and other materials that are suitable for use in medical devices. These materials are selected based on their properties such as chemical resistance, temperature resistance, and mechanical properties.

One of the key requirements of ISO 13485 O-rings is that they must be manufactured in a clean and controlled environment to prevent contamination. This means that the manufacturing process must be carried out in a cleanroom or other controlled environment to minimize the risk of contamination from particles, microorganisms, and other contaminants.

ISO 13485 O-rings must also be tested to ensure that they meet the requirements of the standard. This includes testing for dimensional accuracy, hardness, compression set, tensile strength, and other mechanical properties. In addition, they must also be tested for chemical resistance, biocompatibility, and other properties that are relevant to their intended use.

One of the main benefits of using ISO 13485 O-rings in medical devices is that they provide a high level of assurance that the devices are safe and effective. By using O-rings that have been manufactured and tested in accordance with the requirements of the standard, medical device manufacturers can be confident that their products will meet the regulatory requirements and will not pose a risk to patients.