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This AAMI TIR provides guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135:2014 applies to contract...
This document specifically provides guidance on the application of ANSI/AAMI/ISO11607-1:2006, Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems and ANSI/AAMI/ISO 11607-2:2006, Packaging for...
General This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process improvement and new product evaluation. Inclusions...
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate...
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization...
General This TIR identifies the necessary steps to effectively manage medical devices not owned by the health care facility in which they are used. Inclusions This TIR addresses the management of loaned critical and semi-critical medical devices that require sterilization or high-level...
This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma,...
Parametric release is the declaration of adequacy of routine processing for a validated sterilization process based solely on measurement and documentation of physical process parameters rather than results of biological indicator or product sterility evaluation. This technical information...
This standard provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, highlevel disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes; flexible bronchoscopes; flexible ear, nose, and throat endoscopes; surgical flexible...
General This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/highlevel disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and...
General This recommended practice provides guidelines for EO sterilization processing in hospitals and other health care facilities. These guidelines are intended to promote sterility assurance and to assist health care personnel in the proper use of processing equipment. These guidelines...
Inclusions This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a predetermined sterility assurance level (SAL). This method of sterilization dose...
General This recommended practice provides guidelines for decontamination and dry heat sterilization procedures used in dentists' and physicians' offices, laboratories, ambulatory care clinics, and other health care facilities. These guidelines are intended to promote the assurance of...
This AAMI Technical Information Report (TIR) provides guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products.
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good...
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification. For ease of reference, the clause numbering in this...
