AAMI ST63 pdf free download

AAMI ST63 pdf free download.Sterilization of health care products—Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices—Dry heat.
2.6 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of medical devices—Microbiological methods—Part 1: Estimation of population of microorganisms on products. ANSI/AAMI/ISO 1 1 737-1 :1 995. Arlington (VA): AAMI, 1 995. American National Standard. 2.7 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the validation of a sterilization process. ANSI/AAMI/ISO 1 1 737-2:1 998. Arlington (VA): AAMI, 1 998. American National Standard. 2.8 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Quality systems—Medical devices—Particular requirements for the application of ISO 9001. ANSI/AAMI/ISO 1 3485:1 996. Arlington (VA): AAMI, 1 996. American National Standard. 2.9 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of health care products—Biological indicators—Guidance for the selection, use, and interpretation of results. ANSI/AAMI/ISO 1 41 61 :2000. Arlington (VA): AAMI, 2000. American National Standard. 2.10 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Medical devices— Application of risk management to medical devices. ANSI/AAMI/ISO 1 4971 :2000. Arlington (VA): AAMI, 2000. American National Standard. 2.11 INTERNATIONAL ELECTROTECHNICAL COMMISSION. Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements. IEC 61 01 0-1 :2001 . Geneva: ISO, 2001 . 2.12 INTERNATIONAL ELECTROTECHNICAL COMMISSION. Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-043: Particular requirements for dry heat sterilizers using either hot air of hot inert gas for the treatment of medical materials and for laboratory purposes. IEC 61 01 0-2-043:1 997. Geneva: ISO, 1 997. 3.1 batch: Defined quantity of bulk, intermediate, or finished product that is intended or purported to be uniform in character and quality, and which has been produced during a defined cycle of manufacture. 3.2 bioburden: Population of viable microorganisms on or in a product and/or package. 3.3 bioburden estimate: Value established for the bioburden by applying a factor compensating for the efficiency of the defined technique used in the recovery of microorganisms. 3.4 biological indicator (BI): Inoculated carrier, contained within its primary pack ready for use, that provides a defined resistance to the specified sterilization process. 3.5 calibration: Comparison of a measurement system or device of unknown accuracy to a measurement system or device of known accuracy (traceable to national standards) to detect, correlate, report, or eliminate by adjustment any variation from the required performance limits of the unverified measurement system or device. 3.6 chamber: Enclosed area into which product is placed and in which the sterilization process occurs. NOTE—For purposes of this standard, “chamber” refers not only to closed batch sterilization systems but also to the tunnels of continuous sterilization systems, even though the latter are open at both ends. 3.7 change control: Formal assessment and determination of the appropriateness of a proposed alteration to product or procedure. 3.8 chemical indicator: System that reveals a change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process.3.9 D value; D 10 value: Time or radiation dose required to achieve inactivation of 90 % of a population of the test microorganism under stated exposure conditions. NOTE—For purposes of this standard, “radiation dose” does not apply. 3.10 depyrogenation: Validated process designed to remove or deactivate endotoxin. 3.11 dry heat sterilization: Sterilization process that uses dry heat as the sterilizing agent. 3.12 establish: Determine by theoretical evaluation and confirm by experimentation. 3.13 exposure time: Period for which the process parameters are maintained within their specified tolerances.AAMI ST63 pdf download.