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Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
Download as PDF; Printable version; In other projects ... requires information to allow the design stages applied to the device to be understood as part of the design ...
CSTDs generally follow one of two design concepts, using either a physical barrier or an air-cleaning technology to prevent the escape of hazardous drugs into the work environment. Physical barrier - Blocking the unintended release of drug into the surrounding environment or the intake of environment contaminates into a sterile drug pathway. [8]
BFS-packaged eye drops for single use. Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Lab orders in the LIMS module of the GNU Health project.. A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations.
For example, for a patient who has had a right sided hip replacement who is scheduled for surgery, the return electrode is placed on the left side of the body on the lateral side of the lower abdomen, which places the return electrode between the location of the metal and the surgical site and on the opposite side from the metal.
Standalone software used for diagnostic or therapeutic purposes. Software embedded in a medical device (often referred to as "medical device software"). Software that drives a medical device or determines how it is used. Software that acts as an accessory to a medical device. Software used in the design, production, and testing of a medical ...