Sterilization Standards
Search Results
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HISTORICAL
AAMI/ISO 11135-1 / 11135-2 SET
This document has been replaced. View the most recent version.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (11135-1:2007) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008)
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.
Languages:
Historical Editions: AAMI/ISO 11135:2014, AAMI/ISO TIR11135-2:2008, AAMI/ISO 11135-1:2007, AAMI 11135:1994
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HISTORICAL
AAMI/ISO 11135-1:2007
This document has been replaced. View the most recent version.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/25/2007.
Languages: English
Historical Editions: AAMI/ISO 11135:2014, AAMI/ISO 11135-1 / 11135-2 SET, AAMI/ISO TIR11135-2:2008, AAMI 11135:1994
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MOST RECENT
AAMI/ISO 11135:2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/27/2015.
Languages: English
Historical Editions: AAMI/ISO 11135-1 / 11135-2 SET, AAMI/ISO TIR11135-2:2008, AAMI/ISO 11135-1:2007, AAMI 11135:1994
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MOST RECENT
AAMI/ISO 13004:2022
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 02/09/2024.
Languages: English
Historical Editions: AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]
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MOST RECENT
AAMI/ISO 13408-1:2008/(R)2011/A1:2013
Aseptic processing of health care products--Part 1: General requirements, Amendment 1
Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 03/27/2013.
Languages: English
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HISTORICAL
AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017
This document has been replaced. View the most recent version.
Aseptic processing of health care products--Part 1: General requirements
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.
Languages: English
Amendments, rulings, and supplements: AAMI/ISO 13408-1:2008/(R)2011/A1:2013
Historical Editions: AAMI/ISO 13408-1:2023
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MOST RECENT
AAMI/ISO 13408-1:2023
Aseptic processing of health care products—Part 1: General requirements
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/01/2024.
Languages: English
Historical Editions: AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017
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HISTORICAL
AAMI/ISO 13408-2:2003/(R)2013
This document has been replaced. View the most recent version.
Aseptic processing of health care products - Part 2: Filtration
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.
Languages: English
Historical Editions: AAMI/ISO 13408-2:2018
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MOST RECENT
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 11/17/2017.
Languages: English
Historical Editions: AAMI/ISO 13408-2:2003/(R)2013
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MOST RECENT
AAMI/ISO 13408-3:2006/(R)2015
Aseptic processing of health care products - Part 3: Lyophilization
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.
Languages: English
