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ASME BPE (American Society of Mechanical Engineers: Bioprocessing Equipment) is an international Standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by the ASME Board of Pressure Technologies.
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.
So SAL is used to express the probability of the survival. For example, medical device manufacturers design their sterilization processes for an extremely low SAL, such as 10 −6, which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilization process.
ISO 7197:2006 Neurosurgical implants – Sterile, single-use hydrocephalus shunts and components; ISO 7198:2016 Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches; ISO 7199:2016 Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
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 ...
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.
Design and development planning; Design input, including intended use and user needs (also known as customer attributes) Design output, including evaluation of conformance to design input requirements through: Design verification confirming that the design output meets the design input requirements ("did we design the device right?")
ISO 30005:2012 Ships and marine technology – Ship recycling management systems – Information control for hazardous materials in the manufacturing chain of shipbuilding and ship operations; ISO 30006:2010 Ship recycling management systems – Diagrams to show the location of hazardous materials on board ships