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AAMI STBKCDXL - AAMI STERILIZATION STANDARDS MULTIMEDIA SET
AAMI
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AAMI STBK-S - AAMI STERILIZATION STANDARDS BOOK COLLECTION
AAMI
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AAMI TIR14 - Contract sterilization using ethylene oxide
January 1, 2016 - AAMI

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...

AAMI STD - AAMI STANDARDS ON CD - THE COMPLETE COLLECTION
AAMI
A description is not available for this item.
AAMI TIR22 - Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices— Part 1 and Part 2:2006
January 1, 2007 - AAMI

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...

AAMI TIR15 - Physical aspects of ethylene oxide sterilization
January 1, 2016 - AAMI

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...

AAMI TIR16 - Microbiological aspects of ethylene oxide sterilization
January 1, 2017 - AAMI

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...

AAMI TIR63 - Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
January 1, 2014 - AAMI

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...

AAMI TIR29 - Guide for process characterization and control in radiation sterilization of medical devices
January 1, 2012 - AAMI

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,...

AAMI TIR20 - PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
January 1, 2001 - AAMI

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...

AAMI ST91 - Flexible and semi-rigid endoscope processing in health care facilities
January 1, 2015 - AAMI

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...

AAMI ST58 - Chemical sterilization and high-level disinfection in health care facilities
January 1, 2013 - AAMI

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...

AAMI TIR40 - Sterilization of health care products-Radiation- Guidance on dose setting utilizing a Modified Method 2
January 1, 2018 - AAMI

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...

AAMI ST41 - Ethylene oxide sterilization in health care facilities: Safety and effectiveness
January 1, 2008 - AAMI

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...

AAMI TIR37 - Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products
January 1, 2013 - AAMI

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.

AAMI ST40 - Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
January 1, 2004 - AAMI

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...

AAMI TIR17665-2 - Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
January 1, 2009 - AAMI

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...

AAMI TIR11135-2 - Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
January 1, 2008 - AAMI

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...

CSA PLUS 1173 - Guide to the selection and use of sterilization indicators
January 1, 2012 - CSA

Preface This is the first edition of CSA PLUS 1173, Guide to the selection and use of sterilization indicators. This handbook has been developed to answer general questions in all health care and personal service settings where monitoring of the effectiveness of reprocessing of medical...

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