"Quality control and evaluation of" sterile medical device consists of two parts. The first chapter is the theory part, more comprehensively and systematically introduces the process of producing sterile medical instrument quality management and requirements, from the laws and regulations, administrative supervision, quality management, risk control, clean workshop, laboratory construction, introduction of microorganism, particulate control, pyrogen control, disinfection and sterilization, aseptic packaging, process water and chemical properties and biocompatibility evaluation, statistical technology application and other related content, the theories contact actual, elaborated the content and the related requirements, to ensure that the use of sterile medical device clinical safe and effective. Second experimental guide part, embarks from the reality, through biological testing and sterile medical devices and chemical properties testing, environmental testing and biocompatibility testing, improve the quality inspection personnel aseptic operation level, strengthening professional training in basic skills, help sterile medical device enterprises to better carry out the work of product quality supervision and inspection. This book can be used as a production staff, sterile medical devices business management personnel, testing personnel training materials, but also can be used as medical devices administration and related professional reading reference.
The first piece of sterile medical devices related knowledge, the first chapter of sterile medical equipment and implantable medical devices overview of sterile medical equipment and implantable medical devices industry development and regulation in the second day of sterile medical equipment and implantable medical device special, classification and application of third section of sterile medical equipment and implantable medical devices and main performance biological evaluation of the second chapter of sterile medical device quality management system and regulations first medical device quality management system - section second medical device laws and regulations section third medical risk management requirements of the third chapter of sterile medical equipment products, personnel and clean workshop requirements section without Yin medical products basic requirements section second non Yin medical equipment production and personnel management the third day without Yin medical equipment production of clean plant construction fourth chapter of sterile medical equipment laboratory construction, validation and test the first day of sterile medical equipment laboratory construction and validation of second sterile medical device test item third non Yin examination limitation and sterility assurance level fifth chapter overview of microorganisms and microbial morphology and structure second Festival bacterial growth conditions, metabolism and nutrition section third microbial distribution in nature fourth bacterial morphological examination sixth chapter particulate control section second particles hazards third sources of particulate pollution and control section fourth particles test method Fifth Department of orthopedics implantable medical device end cleaning process to confirm the seventh chapter. The first section of the control of pyrogen pyrogen composition and harm of second physicochemical properties and heat third pyrogen contamination source control section fifth section fourth pyrogen pyrogen test of the eighth chapter of sterile medical instrument disinfection and sterilization and packaging the first non Yin medical instrument disinfection and sterilization of the fundamental concepts of the second day of physical and chemical disinfection eliminate Yin Method third ethylene oxide sterilization process control section fourth damp heat sterilizing process control section fifth radiation sterilization validation and process control in section sixth, chapter ninth packaging process control process water section process water basic knowledge second section of purified water and water for injection monitoring the tenth chapter of sterile medical equipment chemical testing section chemical testing of significance and quality requirements...... Second experimental guide appendix a sterile / implantable medical device related common universal standards and reference guide appendix two national related standard code in Appendix three to the American ASTM standard knowledge introduction appendix four inspection of chemical properties and microbial inspection table
(a) is the main component of the sterilizer vessel, container interior storage sterilization, sterilization sterilization is the place, vessel usually should according to GB150 "steel pressure vessel" national standards for the design, manufacture, inspection and acceptance, and accept the supervision and management of pressure vessel regulations, combined container comprises a cylinder body, a door body and all other related components and the sterilization chamber permanently connected. 1 cylinder block is mainly composed of a chamber and a clamping sleeve, the structure is divided into square and circular, internal and external wall by dissolving and welding. The chamber material usually is a stainless steel plate and pressed into the cylinder, to ensure that no corrosion, no pollution. The clamping sleeve and the reinforcing rib material usually made of stainless steel plate or carbon steel materials. The 2 door door by door body panels, door arm plate and moving mechanism, the door body plate material usually is a stainless steel plate and stiffener, door arm plate material is usually carbon structural steel. The door body is provided with a safety interlocking device, ensure the safety of the equipment to open the door. Unless the maintenance needs to double the sterilizer should not open two doors at the same time. (two) piping materials pipeline system sterilizer mainly for stainless steel material (according to user requirements can also use carbon steel material), the main connector of wire, elbow joint, live. Pipeline by using the function is divided into: into the steam piping, steam exhaust pipe, the vacuum pipeline, pump water inlet pipe and return air pipe. The main components of pipeline pneumatic valve, check valve, manual valve, filter, pressure sensor, pressure gauge, the pilot valve, electromagnetic valve etc.. 1 main steam pipe sterilizer into steam pipeline: external vapor passes through the control valve into the chamber, and also by external vapor passes through the control valve into the jacket, the jacket into the chamber through the control valve. In order to prevent the temperature controller or pressure controller out of control in the operation, operation personnel injury and equipment damage caused by accidents and sterilization, into the steam pipeline usually achieve temperature and pressure. When the chamber of vapor pressure or vapor temperature reaches the preset value, automatically close the inlet valve control system of steam sterilizer, cut into the chamber or the jacket, to prevent the interior or the jacket produce over-voltage and over temperature. The main parts in the steam pipeline by the inlet valve, inlet valve, safety valve and so on.......
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