Sterilization (microbiology) equal to the probability of a non-sterile unit. For high-risk applications, such as medical devices and injections, a sterility assurance level of at least 10 is required by the United States Food and Drug Administration (FDA). A widely used method for heat sterilization is the autoclave, sometimes called a converter or steam sterilizer. Autoclaves use steam heated to under pressure. To achieve sterility, the article is placed in a chamber and heated by injected steam until the article reaches a temperature and time setpoint. Almost all the air is removed from the chamber, because air is undesired in the moist
Medical device Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not require sterilization or do not measure a function) can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the CE mark on the packaging, insert leaflets, etc..