ANSI AAMI ISO 11134 pdf free download

ANSI AAMI ISO 11134 pdf free download.Sterilization of health care products- Requirements for validation and routine control – Industrial moist heat sterilization.
3.4 commissioning: Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification and that it functions within predetermined limits 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 F0 value: F value calculated at 121.1°C (250°F) with a z value of 10 K and a D value of 1 minute.
3.10 materials of construction: Materials used in the sterilization 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 cycles.
3.12 moist heat: Heat that is derived from water, either as a liquid or as steam under pressure.
3.13 moist heat sterilization: Process of using moist heat to produce a sterile product.
3.14 primary packaging: Element of the packaging system that maintains the sterility of the product.
3.15 process lethality: Capability of 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 system: Mechanism used to hold the product and its packaging for sterilization.
NOTE 5 The carrier system should prevent product damage and allow uniform access by the sterilizing agent.
3.17 recommissioning: Repetition of part or all of the commissioning test requirements for the purpose of reconfirming process reliability.
3.18 revalidation: Repetition of part or all of the validation test requirements for the purpose of reconfirming process reliability.
3.19 saturated steam: Water vapor at a temperature corresponding to the boiling point of the source liquid.
3.20 simulated product load: Load that is used as an alternative to the actual product load and that represents an equal or greater challenge to the process.
3.21 sterile: State of being free from viable microorganisms.
NOTE 6 In practice no such absolute statement regarding the absence of microorganisms can be proven (see sterilization).
3.23 sterilization cycle: Automatic sequence of operating stages performed in the sterilizer.
3.24 sterilization process development: Studies conducted to develop a reproducible process by which the product can be sterilized to the desired probability of a non-sterile unit without damage.
3.25 validation: Documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.
NOTE 8 Validation covers three activities: commissioning, verification of process specification and performance qualification.
3.26 z value: Number of degrees of temperature required for a 1-logarithm change in the D value.
4 General
4.1 Responsibilities and training of personnel
Responsibility for the installation and maintenance of moist heat sterilizers, for the validation and routine control of moist heat sterilization, and for the release of sterilized product shall be assigned to qualified personnel as specified in ISO 9001 or in ISO 9002.ANSI AAMI ISO 11134 pdf download.