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A closed system drug transfer device or "CSTD" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. Open versus closed systems are commonly applied in medical devices to maintain the sterility of a fluid pathway.
The system safety concept helps the system designer(s) to model, analyse, gain awareness about, understand and eliminate the hazards, and apply controls to achieve an acceptable level of safety. Ineffective decision making in safety matters is regarded as the first step in the sequence of hazardous flow of events in the "Swiss cheese" model of ...
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 ...
Safety engineering is an engineering discipline which assures that engineered systems provide acceptable levels of safety. It is strongly related to industrial engineering/systems engineering, and the subset system safety engineering. Safety engineering assures that a life-critical system behaves as needed, even when components fail.
With such a wide area of application, not every cleanroom is the same. For example, the rooms utilized in semiconductor manufacturing need not be sterile (i.e., free of uncontrolled microbes), [8] while the ones used in biotechnology usually must be.
Safety engineering is an applied science strongly related to Systems engineering. Safety engineering assures that a life-critical system behaves as needed, even when pieces fail. The main article for this category is Safety engineering .
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.
The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.