ANSI/AAMI/ISO 11134-1993 pdf download.Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization.
3.4 commissioning: Obuaining and documenting evidence that equipment has been provided and insalledd in accordance w ith its specification and that it functions within predetermined limis when operated in accordance with operational instructions.
3.5 D value: Exposure time required under a defined set of conditions to cause a I-logarithm or 90% reduction in the population of a particular microorganism.
3.6 electromechanical control: Control system that uses mechanical means (e.g.. cams or punch cards) to time and initiate the electrical control signals,
3.7 environmental controls: Controls established in the product manufacturing areas to control bioburden.
NOTE 3 These may include air and fluid filters. surface disinfection, personnel uniforms and administrative procedures.
3.8 F value: Measure of the microbiological inactivation capability of a heat sterilization process.
3.9 Fo value: F value calculated al 121.1°C (250^F) with az value of 10 K and a D value of I minute.
3.10 materials of construction: Materials used in the serilization equipment composition.
3.11 microbiological challenge: Biological indicators. biological-indicator test packs. or inoculated product that contain known populations of microorganisms and can be used in testing sterilization cyeles.
3.12 moist heat: Heat that is derived from water. either as a liquid or as steam under pressure.
3.13 moist heat serilization: Process of using moist heat to produce a sterile product.
3.14 primary packaging: Element of the packaging system that maintains the strlity of the product.
3.15 process lethality: Capability ol the sterilization process to destroy microorganisms.
NOTE 4 This can be determined by measurements of microbial death or by establishing and measuring the required physical parameters.
3.16 product carrier sy stem: Mechanism used to hold the product and its packaging for sterilization.
NOTE 5 The carrier system should prevent product damage and allow uniform acess by the stcrilizing agent.
3.17 recomissioning Repetition of part or all ol the comsioning lesl requirements for the purpose of reconfirming process reliability.
3.18 rev alidation: Repeition of part or all of the validation test requirements for the purpose of reconfirming process relibilty.
3.19 saturated steam: Water vapor at a temperature coresponding to the boiling point of the source liquid.
3.20 simulated product load: Load that is used as an atemnative to the actual product load and that represents 2n equal or greater challenge to the process.
3.21 sterile: State of being free from viable microorganisms.
NOTE 6 In practice no such absolute statenent regarding the absence of microorganisms can be proven (see sterilization).
3.22 sterilization: Valdated process used to render a product free of all forms of viable microorganisms.ANSI/AAMI/ISO 11134 pdf download.