STERILIZATION

Sterilization in Health Care Facilities

ANSI/AAMI ST79:2006
ANSI/AAMI ST77:2006

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Containment devices for reusable medical device sterilization

ANSI/AAMI ST42:1998 ANSI/AAMI ST33:1996 AAMI TIR31:2003 ANSI/AAMI ST72:2002 ANSI/AAMI ST41: 1999/(R)2005 ANSI/AAMI ST35:2003 ANSI/AAMI ST58:2005 AAMI TIR12:2004 AAMI TIR30:2003 ANSI/AAMI ST65:2000 AAMI TIR11:2005 ANSI/AAMI ST40:2004 ANSI/AAMI/ISO TIR11139: 2006
Sterilization Equipment

Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care, medical, surgical, and dental facilities Guidelines for the selection and use of reusable rigid container systems for ethylene oxide sterilization and steam sterilization in health care Process challenge devices/test packs for use in health care facilities Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results Ethylene oxide sterilization in health care facilities: Safety and effectiveness Safe handling and biological decontamination of reusable medical devices in health care facilities and in nonclinical settings Chemical sterilization and high-level disinfection in health care facilities Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices Processing of reusable surgical textiles for use in health care facilities Selection and use of protective apparel and surgical drapes in health care facilities Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities Sterilization of health care products - Vocabulary

ANSI/AAMI/ISO 11138-1:2006 ANSI/AAMI/ISO 11138-2:2006 ANSI/AAMI/ISO 11138-3:2006 ANSI/AAMI/ISO 11138-4:2006 ANSI/AAMI/ISO 11138-5:2006 ANSI/AAMI/ISO 11140-1:2005 ANSI/AAMI ST66:1999 ANSI/AAMI/ISO 18472:2006 ANSI/AAMI ST24:1999/(R)2005 ANSI/AAMI ST50:2004 ANSI/AAMI ST55:2003 NSI/AAMI ST8:2001 ANSI/AAMI ST81:2004 ANSI/AAMI/ISO TIR11139:2006

Sterilization of health care products - Biological indicators - Part 1: General requirements Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde Sterilization of health care products - Chemical indicators - Part 1: General requirements Sterilization of health care products - Chemical indicators - Part 2: Class 2 indicators for air removal test sheets and packs Sterilization of health care products - Biological and chemical indicators - Test equipment Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities Dry heat (heated air) sterilizers Table-top steam sterilizers Hospital steam sterilizers Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices Sterilization of health care products - Vocabulary

Ethylene Oxide and Radiation

ANSI/AAMI ST67:2003 ANSI/AAMI/ISO 11135:1994 AAMI TIR14:1997 AAMI TIR14:1997/ A1:2004 AAMI TIR15:1997 AAMI TIR16:2000 ANSI/AAMI/ISO 10993-7:1995/ (R)2001 AAMI TIR19:1998 AAMI TIR19:1998/ A1:1999 AAMI TIR20:2001 AAMI TIR28:2001 ANSI/AAMI/ISO 11137-1:2006 ANSI/AAMI/ISO 11137-2:2006 ANSI/AAMI/ISO 11137-3:2006 AAMI TIR33:2005 AAMI TIR17:1997 ANSI/AAMI TIR35:2006 AAMI TIR29:2002 ANSI/AAMI/ISO TIR11139:2006
Steam and Other

Sterilization of health care products - Requirements for products labeled 'sterile' Medical devices - Validation and routine control of ethylene oxide sterilization Contract sterilization for ethylene oxide Contract sterilization for ethylene oxide, Amendment 1 Ethylene oxide sterilization equipment, process considerations and pertinent calculations Process development and performance qualification for ethylene oxide sterilization - Microbiological aspects Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals Amendment 1 to AAMI TIR19:1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Parametric release for ethylene oxide sterilization Product adoption and process equivalency for ethylene oxide sterilization Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects Sterilization of health care products - Radiation sterilization Substantiation of a selected sterilization dose - Method VDmax Radiation sterilization - Material qualification Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose Guide for process control in radiation sterilization Sterilization of health care products - Vocabulary

ANSI/AAMI/ISO 17665-1:2006 AAMI TIR13:1997 ANSI/AAMI ST67:2003 ANSI/AAMI/ISO 14937:2000 ANSI/AAMI ST63:2002 ANSI/AAMI/ISO 14160:1998 ANSI/AAMI/ISO 11737-1:2006 ANSI/AAMI/ISO 11737-2:1998 ANSI/AAMI/ISO 11737-3:2004 ANSI/AAMI ST72:2002 ANSI/AAMI/ISO 15882:2003 ANSI/AAMI/ISO 14161:2000 ANSI/AAMI/ISO 11607-1:2006 ANSI/AAMI/ISO 11607-2:2006
AAMI TIR22:2006

Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization Principles of industrial moist heat sterilization Sterilization of health care products - Requirements for products labeled 'sterile' Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation Sterilization of health care products - Requirements for the development, validation and routine control of an industrial sterilization Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data Bacterial endotoxin -Test methodologies, routine monitoring and alternatives to batch testing Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices Sterilization of health care products - Vocabulary

ANSI/AAMI/ISO TIR11139:2006