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AAMI - AAMI STBK-S - AAMI STERILIZATION STANDARDS BOOK COLLECTION Organization: AAMI
AAMI - AAMI STBKCDXL - AAMI STERILIZATION STANDARDS MULTIMEDIA SET Organization: AAMI
AAMI - AAMI TIR22 - GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES— PART 1 AND PART 2:2006 - INCORPORATES AMENDMENT 1: 2008 Organization: AAMI
Date: 2007-01-01
Description: 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 terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes within the regulatory framework of the United States Food and Drug Administration that exists at the time of the publication of this document.
AAMI - AAMI STBKCD - AAMI STANDARDS ON CD - STERILIZATION EDITION (50+ AAMI STANDARDS AND GUIDANCE DOCUMENTS FOR STERILIZATION ON A CD) Organization: AAMI
AAMI - TIR19 - GUIDANCE FOR ANSI/AAMI/ISO 10993-7:1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS - REPLACES AAMI ST29 AND AAMI ST30; CITED AS RELEVANT GUIDANCE TO FDA-RECOGNIZED STANDARD ANSI/AAMI/ISO 10993-7 Organization: AAMI
Date: 1998-01-01
Description: This AAMI Technical Information Report (TIR) provides guidance to augment ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals. This TIR is intended to assist those individuals using ANSI/AAMI/ISO 10993-7 in understanding the steps necessary to evaluate an ethylene oxide-sterilized device according to the standard and to help those individuals choose appropriate actions where alternatives are given.
AAMI - TIR19 AMD 1 - GUIDANCE FOR ANSI/AAMI/ISO 10993-7:1995, BIOLOGICAL EVALUATION OF MEDICAL DEICES—PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS AMENDMENT Organization: AAMI
Date: 1999-01-01
AAMI - AAMI TIR19 - GUIDANCE FOR ANSI/AAMI/ISO 10993-7:1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS Organization: AAMI
AAMI - AAMI TIR17665-2 - STERILIZATION OF HEALTH CARE PRODUCTS — MOIST HEAT — PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 Organization: AAMI
Date: 2009-01-01
Description: 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.
AAMI - AAMI TIR11135-2 - STERILIZATION OF HEALTH CARE PRODUCTS — ETHYLENE OXIDE — PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1 Organization: AAMI
Date: 2008-01-01
Description: This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135- 1.
AAMI - ST55 - TABLE-TOP STEAM STERILIZERS - FDA RECOGNIZED Organization: AAMI
Date: 2010-01-01
Description: NOTE—Minimum labeling and performance requirements for large steam sterilizers (those having a volume greater than 56.63 liters [2 ft3]) are covered in ANSI/AAMI ST8. Guidelines for steam sterilization procedures in health care facilities, including typical steam sterilization cycle parameters, are provided in ANSI/AAMI ST79.
AAMI - AAMI ST8 - HOSPITAL STEAM STERILIZERS - FDA RECOGNIZED Organization: AAMI
Date: 2013-01-01
Description: NOTE—Minimum labeling and performance requirements for small steam sterilizers (those that are 56.63 L [2 ft3] or less in volume) are covered in ANSI/AAMI ST55; guidelines for the use of such sterilizers are provided in ANSI/AAMI ST79. ANSI/AAMI ST79 also covers inhospital steam sterilization procedures and quality control, as well as the selection and use of containment devices intended for use in steam sterilization.
AAMI - STBK-2 - STERILIZATION PART 2: STERILIZATION EQUIPMENT DESIGN AND USE Organization: AAMI
Date: 2010-01-01
Description: Additional guidance documents cover biological indicators (11138 series), packaging (11607 series), EO sterilizers, dry heat sterilizers, table-top steam sterilizers, and more.
AAMI - AAMI TIR14 - CONTRACT STERILIZATION USING ETHYLENE OXIDE Organization: AAMI
Date: 2016-01-01
Description: This TIR addresses how ANSI/AAMI/ISO 11135:2014 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
AAMI - AAMI ST50 - DRY HEAT (HEATED AIR) STERILIZERS - FDA RECOGNIZED Organization: AAMI
Date: 2004-01-01
Description: NOTE—For guidelines on sterilization procedures, sterility assurance procedures, and other aspects of the use of dry heat sterilizers within health care facilities, see ANSI/AAMI ST40.
AAMI - TIR15 - PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION Organization: AAMI
Date: 2009-01-01
Description: This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135–1:2007. 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 relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence.
AAMI - TIR29 - GUIDE FOR PROCESS CONTROL IN RADIATION STERILIZATION Organization: AAMI
Date: 2012-01-01
Description: 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, electron beam, and X-ray sterilization.
AAMI - AAMI TIR16 - MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION Organization: AAMI
Date: 2009-01-01
Description: It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
AAMI - AAMI TIR20 - PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION - CITED BY FDA AS "RELEVANT GUIDANCE" FOR ANSI/AAMI/ISO 11135: 1994 Organization: AAMI
Date: 2001-01-01
Description: Product adoption and process equivalency are not addressed in this document but will be addressed in a separate Association for the Advancement of Medical Instrumentation (AAMI) TIR.
AAMI - AAMI TIR37 - STERILIZATION OF HEALTH CARE PRODUCTS-RADIATION-GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS Organization: AAMI
Date: 2013-01-01
Description: 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 - AAMI TIR33 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE - METHOD VDMAX Organization: AAMI
Date: 2005-01-01
Description: This TIR also specifies a method of dose auditing to demonstrate the continued effectiveness of the sterilization dose. NOTE 1—This method of sterilization dose substantiation may be used to meet the product qualification requirements specified in ANSI/AAMI/ISO 11137.

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