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The Association for the Advancement of Medical Instrumentation (AAMI) is an organization for advancing the development, and safe and effective use of medical technology founded in 1965 by Robert D. Hall Jr. and Robert J. Allen, President and Vice President respectively of Tech/Reps, Inc. (a medical Instrumentation marketing firm in Needham, Massachusetts).
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. A very effective sterilization process has a very low SAL.
The time is counted once the temperature that is needed has been reached. Steam sterilization requires four conditions in order to be efficient: adequate contact, sufficiently high temperature, correct time and sufficient moisture. [16] Sterilization using steam can also be done at a temperature of 132 C (270 F), at a double pressure. [citation ...
Earle Spaulding of Temple University (Philadelphia, Pennsylvania) in a 1939 paper on disinfection of surgical instruments in a chemical solution proposed "a strategy for sterilization or disinfection of inanimate objects and surfaces based on the degree of risk involved in their use". [1]
The Association for Professionals in Infection Control and Epidemiology (APIC) is a private nonprofit professional organization based in Arlington, VA for healthcare practitioners dedicated to the principles of infection control. APIC has more than 15,000 members. APIC concentrates its efforts in the hospital, nursing home and home health settings.
The goal of asepsis is to eliminate infection, not to achieve sterility. [1] Ideally, a surgical field is sterile, meaning it is free of all biological contaminants (e.g. fungi, bacteria, viruses), not just those that can cause disease, putrefaction, or fermentation. [1] Even in an aseptic state, a condition of sterile inflammation may develop.
Microorganisms growing on an agar plate. Sterilization (British English: sterilisation) refers to any process that removes, kills, or deactivates all forms of life (particularly microorganisms such as fungi, bacteria, spores, and unicellular eukaryotic organisms) and other biological agents (such as prions or viruses) present in fluid or on a specific surface or object. [1]
The aim of bioburden testing is to measure the total number of viable micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use. [ 2 ] 21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process ...