Monday, 7 October 2013

Sterilization and disinfection standards


Here is a handy list of sterilization and disinfection standards:
  • ASTM-E1173 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
  • ASTM-E1327 - Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions
  • ASTM-E1837 - Standard Test Method To Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
  • ASTM-E1838 - Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
  • ASTM-E2414 - Standard Test Method for Quantitative Sporicidal Three-Step Method (Tsm) To Determine Sporicidal Efficacy of Liquids, Liquid Sprays, and Vapor or Gases on Contaminated Carrier Surfaces


  • BS-EN-1174-1 - Part 1: Requirements, Sterilization of Medical Devices, Estimations of the Population Of
  • BS-EN-1174-2 - Part 2: Guidance, Sterilization of Medical Devices, Estimation of the Population of Micro
  • BS-EN-1174-3 - Part 3: Guide To the Methods for Validation of Microbiological Techniques.
  • BS-EN-13824 - Sterilization of Medical Devices. Aseptic Processing of Liquid Medical Devices. Requirements
  • BS-EN-15424 - Sterilization of Medical Devices. Low Temperature Steam and Formaldehyde. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-550 - Sterilization of Medical Devices, Validation & Routine Control of Ethylene Oxide Sterili
  • BS-EN-552 - Sterilization of Medical Devices. Validation and Routine Control of Sterilization by Irradiation
  • BS-EN-554 - Sterilization of Medical Devices. Validation and Routine Control of Sterilization by Moist Heat
  • BS-EN-556-1 - Sterilization of Medical Devices. Requirements for Medical Devices To Be Designated Sterile. Requirements for Terminally Sterilized Medical Devices
  • BS-EN-866-1 - Biological Systems for Testing Sterilizers & Sterilization Process. General Requiremen
  • BS-EN-866-2 - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers, Biological Systems for T
  • BS-EN-866-3 - Part 3: Particular Systems for Use in Moist Heat Sterilizers, Biological Systems for Testi
  • BS-EN-ISO-11135-1 - Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-ISO-11137-1 - Sterilization of Health Care Products. Radiation. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-ISO-11137-2 - Sterilization of Health Care Products. Radiation. Establishing the Sterilization Dose
  • BS-EN-ISO-11137-3 - Sterilization of Health Care Products. Radiation. Guidance on Dosimetric Aspects
  • BS-EN-ISO-11138-1 - Sterilization of Health Care Products. Biological Indicators. General Requirements
  • BS-EN-ISO-11138-2 - Sterilization of Health Care Products. Biological Indicators. Biological Indicators for Ethylene Oxide Sterilization Processes
  • BS-EN-ISO-11138-3 - Sterilization of Health Care Products. Biological Indicators. Biological Indicators for Moist Heat Sterilization Processes
  • BS-EN-ISO-11138-4 - Sterilization of Health Care Products. Biological Indicators. Biological Indicators for Dry Heat Sterilization Processes
  • BS-EN-ISO-11138-5 - Sterilization of Health Care Products. Biological Indicators. Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes
  • BS-EN-ISO-11140-1 - Sterilization of Health Care Products. Chemical Indicators. General Requirements
  • BS-EN-ISO-11140-3 - Sterilization of Health Care Products. Chemical Indicators. Class 2 Indicator Systems for Use in the Bowie and Dick-Type Steam Penetration Test
  • BS-EN-ISO-11140-4 - Sterilization of Health Care Products. Chemical Indicators. Class 2 Indicators as an Alternative To the Bowie and Dick-Type Test for Detection of Steam Penetration
  • BS-EN-ISO-11737-1 - Sterilization of Medical Devices. Microbiological Methods. Determination of a Population of Microorganisms on Products
  • BS-EN-ISO-11737-2 - Sterilization of Medical Devices. Microbiological Methods. Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
  • BS-EN-ISO-13408-1 - Aseptic Processing of Health Care Products. General Requirements
  • BS-EN-ISO-13408-2 - Aseptic Processing of Health Care Products. Filtration
  • BS-EN-ISO-13408-3 - Aseptic Processing of Health Care Products. Lyophilization
  • BS-EN-ISO-13408-4 - Aseptic Processing of Health Care Products. Clean-In-Place Technologies
  • BS-EN-ISO-13408-5 - Aseptic Processing of Health Care Products. Sterilization in Place
  • BS-EN-ISO-13408-6 - Aseptic Processing of Health Care Products. Isolator Systems
  • BS-EN-ISO-14160 - Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-ISO-14161 - Sterilization of Health Care Products. Biological Indicators. Guidance for the Selection, Use and Interpretation of Results
  • BS-EN-ISO-14937 - Sterilization of Health Care Products. General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-ISO-15882 - Sterilization of Health Care Products. Chemical Indicators. Guidance for Selection, Use and Interpretation of Results
  • BS-EN-ISO-16201 - Technical Aids for Disabled Persons. Environmental Control Systems for Daily Living
  • BS-EN-ISO-17665-1 - Sterilization of Health Care Products. Moist Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-ISO-18472 - Sterilization of Health Care Products. Biological and Chemical Indicators. Test Equipment and Methods
  • BS-EN-ISO-20857 - Sterilization of Health Care Products. Dry Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-EN-ISO-25424 - Sterilization of Medical Devices. Low Temperature Steam and Formaldehyde. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • BS-ISO-11140-5 - Sterilization of Health Care Products. Chemical Indicators. Class 2 Indicators for Bowie and Dick-Type Air Removal Tests
  • BS-ISO-13408-7 - Aseptic Processing of Health Care Products. Alternative Processes for Medical Devices and Combination Products
  • DD-CEN-ISO-11135-2 - Sterilization of Health Care Products. Ethylene Oxide. Guidance on the Application of ISO 11135-1
  • DD-CEN-ISO-17665-2 - Sterilization of Health Care Products. Moist Heat. Guidance on the Application of ISO 17665-1
  • ISO-11134 - Sterilization of Health Care Products - Requirements for Validation & Routine Control - In
  • ISO-11135 - Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization (Replaced by ISO-11135-1 and ISO-11135-2)
  • ISO-11135-1 - Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO-11135-2 - Sterilization of Health Care Products - Ethylene Oxide - Part 2: Guidance on the Application of ISO 11135-1
  • ISO-11137 - Sterilization of Health Care Products -- Requirements for Validation and Routine Control -- Radiation Sterilization
  • ISO-11137-1 - Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO-11137-1-AM1 - - Amendment 1
  • ISO-11137-2 - Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose
  • ISO-11137-3 - Sterilization of Health Care Products - Radiation - Part 3: Guidance on Dosimetric Aspects
  • ISO-11137-AM1 - Amendment 1: Selection of Items for Dose Setting, Sterilization of Health Care Product
  • ISO-11138-1 - Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements
  • ISO-11138-2 - Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes
  • ISO-11138-3 - Sterilization of Health Care Products - Biological Indicators - Part 3: Biological Indicators for Moist Heat Sterilization Processes
  • ISO-11138-4 - Sterilization of Health Care Products - Biological Indicators - Part 4: Biological Indicators for Dry Heat Sterilization Processes
  • ISO-11138-5 - Sterilization of Health Care Products - Biological Indicators - Part 5: Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes
  • ISO-11139 - Sterilization of Health Care Products - Vocabulary
  • ISO-11140-1 - Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements
  • ISO-11140-1-1 - Amendment 1: Part 1: General Requirements, Sterilization of Health Care Products - Ch
  • ISO-11140-2 - Part 2: Test Equipment & Methods, Sterilization of Health Care Products - Chemical Indicat
  • ISO-11140-3 - Sterilization of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicator Systems for Use in the Bowie and Dick-Type Steam Penetration Test
  • ISO-11140-4 - Sterilization of Health Care Products - Chemical Indicators - Part 4: Class 2 Indicators as an Alternative To the Bowie and Dick-Type Test for Detection of Steam Penetration
  • ISO-11140-5 - Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick-Type Air Removal Tests
  • ISO-11737-1 - Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products
  • ISO-11737-2 - Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
  • ISO-11737-3 - Sterilization of Medical Devices - Microbiological Methods - Part 3: Guidance on Evaluation and Interpretation of Bioburden Data
  • ISO-13004 - Sterilization of Health Care Products - Radiation - Substantiation of Selected Sterilization Dose: Method Vdmaxsd
  • ISO-13408-1 - Aseptic Processing of Health Care Products - Part 1: General Requirements
  • ISO-13408-1-AM1 - - Amendment 1
  • ISO-13408-2 - Aseptic Processing of Health Care Products - Part 2: Filtration
  • ISO-13408-3 - Aseptic Processing of Health Care Products - Part 3: Lyophilization
  • ISO-13408-4 - Aseptic Processing of Health Care Products - Part 4: Clean-In-Place Technologies
  • ISO-13408-5 - Aseptic Processing of Health Care Products - Part 5: Sterilization in Place
  • ISO-13408-6 - Aseptic Processing of Health Care Products - Part 6: Isolator Systems
  • ISO-13408-6-AM1 - - Amendment 1
  • ISO-13408-7 - Aseptic Processing of Health Care Products - Part 7: Alternative Processes for Medical Devices and Combination Products
  • ISO-13409 - Sterilization of Health Care Products-Radiation Sterilization-Substantiation of 25 Kgy
  • ISO-13683 - Sterilization of Health Care Products - Requirements for Validation & Routine Control of M
  • ISO-14160 - Sterilization of Health Care Products - Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives - Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO-14161 - Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results
  • ISO-14937 - Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO-15843 - Sterilization of Health Care Products-Radiation Sterilization-Product Families and Sam
  • ISO-15844 - Sterilization of Health Care Products - Radiation Sterilization - Selection of Sterilizati
  • ISO-15882 - Sterilization of Health Care Products - Chemical Indicators - Guidance for Selection, Use and Interpretation of Results
  • ISO-17664 - Sterilization of Medical Devices - Information To Be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
  • ISO-17665-1 - Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO-17665-2 - Sterilization of Health Care Products - Moist Heat - Part 2: Guidance on the Application of ISO 17665-1
  • ISO-17665-3 - Sterilization of Health Care Products - Moist Heat - Part 3: Guidance on the Designation of a Medical Device To a Product Family and Processing Category for Steam Sterilization
  • ISO-18472 - Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
  • ISO-20857 - Sterilization of Health Care Products - Dry Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO-25424 - Sterilization of Medical Devices - Low Temperature Steam and Formaldehyde - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • ISO/DIS-11135 - Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Val
  • ISO/DIS-17664 - Information To Be Provided by the Manufacturer for the Reprocessing of Resterilizable Devices
  • AAMI/ISO-11137-1 - Sterilization of Health Care Products - Radiation - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • AAMI/ISO-11137-2 - Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose (ANSI/AAMI/ISO 11137-2:2013)
  • ANSI/AAMI-ST79 - Comprehensive Guide To Steam Sterilization and Sterility Assurance in Health Care Facilities (ANSI/AAMI St79:2010 & a1:2010 & a2:2011 & a3:2012)
  • ANSI/AAMI/ISO-11139 - Sterilization of Health Care Products - Vocabulary
  • ANSI/AAMI/ISO-14160 - Sterilization of Health Care Products - Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives - Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Ani/AAMI/ISO 14160:2011)
  • ANSI/AAMI/ISO-15882 - Sterilization of Health Care Products - Chemical Indicators - Guidance for Selection, Use and Interpretation of Results
  • ANSI/AAMI/ISO-18472 - Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
  • ANSI/AAMI/ISO-20857 - Sterilization of Health Care Products - Dry Heat: Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices
  • ANSI/AAMI/ISO11138-1 - Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements
  • ANSI/AAMI/ISO11138-2 - Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes
  • ANSI/AAMI/ISO11138-3 - Sterilization of Health Care Products - Biological Indicators -Part 3: Biological Indicators for Moist Heat Sterilization Processes
  • ANSI/AAMI/ISO11138-4 - Sterilization of Health Care Products - Biological Indicators - Part 4: Biological Indicators for Dry Heat Sterilization Processes
  • ANSI/AAMI/ISO11138-5 - Sterilization of Health Care Products - Biological Indicators - Part 5: Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes
  • ANSI/AAMI/ISO11140-1 - Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements
  • ANSI/AAMI/ISO11737-1 - Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products
  • ANSI/AAMI/ISO11737-2 - Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
  • ANSI/AAMI/ISO11737-3 - Sterilization of Medical Devices - Microbiological Methods - Part 3: Guidance on Evaluation and Interpretation of Bioburden Data
  • ANSI/AAMI/ISO17665-1 - Sterilization of Health Care Products -- Moist Heat -- Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • DIN-EN-13824 - Sterilization of Medical Devices - Aseptic Processing of Liquid Medical Devices - Requirements
  • DIN-EN-ISO-11138-1 - Part 1: General Requirements, Sterilization of Health Care Products - Biological Indic
  • DIN-EN-ISO-11138-2 - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes, Sterilizatio
  • DIN-EN-ISO-11138-3 - Part 3: Biological Indicators for Moist Heat Sterilization Processes, Sterilization Of
  • DIN-EN-ISO-11138-4 - Part 4: Biological Indicators for Dry Heat Sterilization Processes, Sterilization of H
  • DIN-EN-ISO-11138-5 - Part 5: Biological Indicators for Low-Temperature Steam & Foormaldehyde Sterilization
  • DIN-EN-ISO-11140-1 - Part 1: General Requirements, Sterilization of Health Care Products - Chemical Indicat
  • DIN-EN-ISO-11737-1 - Part 1: Determination of a Population of Microorganisms on Products, Sterilization Of
  • DIN-EN-ISO-17665-1 - Part 1: Requirements for the Development, Validation & Routine Control of a Sterilizat
  • DIN-EN-ISO-18472 - Sterilization of Health Care Products - Biological & Chemical Indicators - Test Equipm
  • EN-13824 - Sterilization of Medical Devices, Aseptic Processing of Liquid Medical Devices, Requir
  • EN-15424 - Sterilization of Medical Devices, Low Temperature Steam & Formaldehyde, Requirements F
  • EN-556 - Sterilization of Medical Devices - Requirements for Terminally-Sterilized Medical Devi
  • EN-556-1 - Part 1: Requirements for Terminally Sterilized Medical Devices, Sterilization of Medic
  • EN-ISO-11135-1 - Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (ISO 11135-1:2007)
  • EN-ISO-11135-2 - Sterilization of Health Care Products - Ethylene Oxide - Part 2: Guidance on the Application of ISO 11135-1 (ISO/Ts 11135-2:2008)
  • EN-ISO-11137-1 - Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (ISO 11137-1:2006/AMD 1:2013)
  • EN-ISO-11137-2 - Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose (ISO 11137-2:2012)
  • EN-ISO-11137-3 - Sterilization of Health Care Products - Radiation - Part 3: Guidance on Dosimetric Aspects (ISO 11137-3:2006)
  • EN-ISO-11138-1 - Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements (ISO 11138-1:2006)
  • EN-ISO-11138-2 - Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes (ISO 11138-2:2006)
  • EN-ISO-11138-3 - Sterilization of Health Care Products - Biological Indicators - Part 3: Biological Indicators for Moist Heat Sterilization Processes (ISO 11138-3:2006)
  • EN-ISO-11138-4 - Sterilization of Health Care Products - Biological Indicators - Part 4: Biological Indicators for Dry Heat Sterilization Processes (ISO 11138-4:2006)
  • EN-ISO-11138-5 - Sterilization of Health Care Products - Biological Indicators - Part 5: Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes (ISO 11138-5:2006)
  • EN-ISO-11140-1 - Sterilization of Health Care Products, Chemical Indicators, General Requirements
  • EN-ISO-11140-3 - Sterilization of Health Care Products, Chemical Indicators, Class 2 Indicator Systems
  • EN-ISO-11140-4 - Part 4: Class 2 Indicators as an Alternative To the Bowie & Dick-Type Test for Detect
  • EN-ISO-11737-1 - Part 1: Determination of a Population of Microorganisms on Products, Sterilization Of
  • EN-ISO-11737-2 - Part 2: Tests of Sterility Performed in the Definition, Validation & Maintenance of A
  • EN-ISO-13408-1 - Aseptic Processing of Health Care Products - Part 1: General Requirements
  • EN-ISO-13408-2 - Aseptic Processing of Health Care Products - Part 2: Filtration
  • EN-ISO-13408-3 - Aseptic Processing of Health Care Products - Part 3: Lyophilization
  • EN-ISO-13408-4 - Aseptic Processing of Health Care Products - Part 4: Clean-In-Place Technologies
  • EN-ISO-13408-5 - Aseptic Processing of Health Care Products - Part 5: Sterilization in Place
  • EN-ISO-13408-6 - Aseptic Processing of Health Care Products - Part 6: Isolator Systems
  • EN-ISO-14160 - Sterilization of Health Care Products - Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives - Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • EN-ISO-14161 - Sterilization of Health Care Products - Biological Indicators - Guidance for the Selec
  • EN-ISO-14937 - Sterilization of Health Care Products - General Requirements for Characterization of A
  • EN-ISO-15882 - Sterilization of Health Care Products, Chemical Indicators, Guidance for Selection, U
  • EN-ISO-17665-1 - Part 1: Requirements for the Development, Validation & Routine Control of a Sterilizat
  • EN-ISO-18472 - Sterilization of Health Care Products - Biological & Chemical Indicators - Test Equipm
  • EN-ISO-20857 - Sterilization of Health Care Products - Dry Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (ISO 20857:2010)
  • EN-ISO-25424 - Sterilization of Medical Devices - Low Temperature Steam and Formaldehyde - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Posted by Tim Sandle

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