Document Center List of Standards on Sterilization And Disinfection In General Including Sterilization Methods, Air Quality Of Surgery Rooms, Etc.
ICS Code 11.080.01
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-E1173 - Standard Test Method for Evaluation of 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Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) (Withdrawn 2023)
- 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(TSM) to Determine Sporicidal Efficacy of Liquids, Liquid Sprays, and Vapor or Gases on Contaminated Carrier Surfaces (Withdrawn 2014)
- ASTM-F3127 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
- ASTM-F3208 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
BSI:
- BS-5283 - Glossary of terms relating to disinfectants
- 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 - Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
- BS-EN-556-1 - Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'
- BS-EN-556-2 - Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'
- 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 - Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
- BS-EN-ISO-11135-1 - Sterilization of health care products. Ethylene oxide
- BS-EN-ISO-11137-1 - Sterilization of health care products. Radiation
- BS-EN-ISO-11137-2 - Sterilization of health care products. Radiation
- BS-EN-ISO-11137-2-TC - Tracked Changes. Sterilization of health care products. Radiation
- BS-EN-ISO-11137-3 - Sterilization of health care products. Radiation
- BS-EN-ISO-11137-3-TC - Tracked Changes. Sterilization of health care products. Radiation
- BS-EN-ISO-11138-1 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-1-TC - Tracked Changes. Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-2 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-3 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-4 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-4-TC - Tracked Changes. Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-5 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-5-TC - Tracked Changes. Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-7 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11138-8 - Sterilization of health care products. Biological indicators
- BS-EN-ISO-11139 - Sterilization of health care products. Vocabulary. Terms used in sterilization and related equipment and process standards
- BS-EN-ISO-11140-1 - Sterilization of health care products. Chemical indicators
- BS-EN-ISO-11140-3 - Sterilization of health care products. Chemical indicators
- BS-EN-ISO-11140-4 - Sterilization of health care products. Chemical indicators
- BS-EN-ISO-11737-1 - Sterilization of health care products. Microbiological methods
- BS-EN-ISO-11737-2 - Sterilization of health care products. Microbiological methods
- BS-EN-ISO-13408-1 - Aseptic processing of health care products
- BS-EN-ISO-13408-1-TC - Tracked Changes. Aseptic processing of health care products
- BS-EN-ISO-13408-2 - Aseptic processing of health care products
- BS-EN-ISO-13408-2-TC - Tracked Changes. Aseptic processing of health care products
- BS-EN-ISO-13408-3 - Aseptic processing of health care products
- BS-EN-ISO-13408-4 - Aseptic processing of health care products
- BS-EN-ISO-13408-5 - Aseptic processing of health care products
- BS-EN-ISO-13408-6 - Aseptic processing of health care products
- BS-EN-ISO-13408-6-TC - Tracked Changes. Aseptic processing of health care products
- BS-EN-ISO-13408-7 - Aseptic processing of health care products. Alternative processes for medical devices and combination products
- 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-14160-TC - Tracked Changes. 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-17664-1 - Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
- BS-EN-ISO-17664-1-TC - Tracked Changes. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
- BS-EN-ISO-17664-TC - Tracked Changes. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
- BS-EN-ISO-17665-1 - Sterilization of health care products. Moist heat
- BS-EN-ISO-18472 - Sterilization of health care products. Biological and chemical indicators. Test equipment
- BS-EN-ISO-18472-TC - Tracked Changes. Sterilization of health care products. Biological and chemical indicators. Test equipment
- 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 health care products. 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
- BS-ISO-13004 - Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
- BS-ISO-13408-7 - Aseptic processing of health care products. Alternative processes for medical devices and combination products
- BS-ISO-17664-2 - Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
- BS-ISO-22441 - Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
- 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
- PD-CEN-ISO-13004 - Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
- PD-ISO-11137-4 - Sterilization of health care products. Radiation
- PD-ISO-13004 - Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VD$dm$da$dxSD
- PD-ISO-17665-3 - Sterilization of health care products. Moist heat
- PD-ISO-19930 - Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
- PD-ISO-20520 - Traditional Chinese medicine. Infection control for acupuncture treatment
- PD-ISO-21387 - Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
- PD-ISO-22421 - Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
- PD-ISO-22456 - Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
- PD-ISO-5111 - Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
ISO:
- ISO-11134 - Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization
- ISO-11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- 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-11135/11137/1160 - ISO 11135, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11607-1 and ISO 11607-2
- ISO-11135-2 - Corrigendum
- ISO-11135-AM1 - - Amendment 1: Revision of Annex E, Single batch release
- ISO-11135 PACKAGE - ISO 11135 - Sterilization of Health Care Products Package (Ethylene Oxide process)
- 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-11137-1-AM2 - - Amendment 2: Revision to 4.3.4 and 11.2
- ISO-11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ISO-11137-2-AM1 - - Amendment 1: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1
- ISO-11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- ISO-11137-4 - Sterilization of health care products - Radiation - Part 4: Guidance on process control
- ISO-11137-AM1 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilizationAmendment 1: Selection of items for dose setting
- 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-11138-7 - Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
- ISO-11138-8 - Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
- ISO-11139 - Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
- ISO-11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements
- ISO-11140-1-1 - Amendment
- ISO-11140-2 - Sterilization of health care products -- Chemical indicators -- Part 2: Test equipment and methods
- 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-11140-6 - Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
- ISO-11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ISO-11737-1-AM1 - - Amendment 1
- ISO-11737-2 - Sterilization of health care products - 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: Sterilizing 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 as a sterilization dose for small or infrequent production batches
- ISO-13683 - Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
- 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 sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
- ISO-15844 - Sterilization of health care products -- Radiation sterilization -- Selection of sterilization dose for a single production batch
- ISO-15882 - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
- ISO-17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
- ISO-17664-1 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
- ISO-17664-2 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical 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-18362 - Manufacture of cell-based health care products - Control of microbial risks during processing
- ISO-18362-AM1 - - Amendment 1: Manufacture of cell-based health care products - Control of microbial risks during processing - Amendment 1
- ISO-18472 - Sterilization of health care products - Biological and chemical indicators - Test equipment
- ISO-19930 - Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
- ISO-20520 - Traditional Chinese medicine - Infection control for acupuncture treatment
- 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-21387 - Sterilization of medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
- ISO-22421 - Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
- ISO-22441 - Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO-22456 - Sterilization of healthcare products - Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
- ISO-25424 - Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO-25424-AM1 - - Amendment 1: Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
- ISO-5111 - Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
- ISO/DIS-11135 - Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Val
- ISO/DIS-11138-8 - Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator
- ISO/DIS-17664 - Information To Be Provided by the Manufacturer for the Reprocessing of Resterilizable Devi
Other SDOs:
- 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-11137-1-AM2 - 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)
- AAMI/ISO-11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- AAMI/ISO-11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
- AAMI/ISO-11138-2 - Sterilization of health care products- -Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- AAMI/ISO-11138-3 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- AAMI/ISO-11138-4 - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
- AAMI/ISO-11138-5 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes - American National Standard
- AAMI/ISO-11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements
- AAMI/ISO-11140-3 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
- AAMI/ISO-11140-4 - Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
- AAMI/ISO-11140-5 - Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
- AAMI/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
- AAMI/ISO-17665-2 - Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
- AAMI/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
- AAMI-ST58 - Chemical sterilization and high-level disinfection in health care facilities
- AAMI-TIR16 - Microbiological aspects of ethylene oxide sterilization
- AAMI-TIR17 - Compatibility of materials subject to sterilization
- AAMI-TIR20 - Parametric release for ethylene oxide sterilization
- AAMI-TIR27 - Sterilization Of Health Care Products - Radiation Sterilization - Substantiation Of 25 Kgy As A Sterilization Dose - Method Vd Max
- AAMI-TIR29 - Guide for process control in radiation sterilization
- AAMI-TIR33 - Sterilization of health care products - Radiation sterilization - Substantiation of a selected sterilization dose - Method VDmax
- AAMI-TIR35 - Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
- AAMI-TIR37 - Sterilization of health care products - Radiation - Guidance on sterilization of biologics and tissue-based products
- AAMI-TIR40 - Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
- AAMI-TIR56 - Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of 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/ISO-11139 - Sterilization of health care products - Vocabulary
- 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/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 pro
- ANSI/AAMI/ISO-15882 - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
- ANSI/AAMI/ISO-17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
- 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
- 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 a sterilization process for medical devices
- ANSI/AAMI-ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2017)
- DIN-EN-13824 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements; German version EN 13824:2004
- DIN-EN-556-2 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
- DIN-EN-ISO-11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
- DIN-EN-ISO-11138-2 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- DIN-EN-ISO-11138-3 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- DIN-EN-ISO-11138-4 - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
- DIN-EN-ISO-11138-5 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- DIN-EN-ISO-11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements
- DIN-EN-ISO-11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
- 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. Requirements - Replaced by EN-ISO-13408-1
- 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-556-2 - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
- EN-ISO-11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
- 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
- EN-ISO-11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- EN-ISO-11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- EN-ISO-11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
- EN-ISO-11138-2 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- EN-ISO-11138-3 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- EN-ISO-11138-4 - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
- EN-ISO-11138-5 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- EN-ISO-11138-7 - Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
- EN-ISO-11139 - Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
- EN-ISO-11140-1 - Sterilization of health care products - Chemical indicators - Part 1: 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-13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
- 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
- SIS-CEN-ISO-17665-2 - Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
- SIS-CEN-ISO/TS-11135-2 - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
- SIS-CEN-ISO/TS-16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
- SIS-CEN-ISO/TS-17665-2 - Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
- SIS-EN-ISO-17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
- SIS-EN-ISO/TS-13004 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
- SIS-ISO/TS-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/TS 17665-3:2013, IDT)
- SIS-ISO/TS-22421 - Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)
- SIS-TR-323 - Programming languages - BASIC
- SIS-TR-57 - Guide for basic recommendations for storage, handling, and transportation of sterile medical devices in health care, dental care, and veterinary care
- SIS-TS-39 - Microbiological cleanliness in the operating room - Preventing airborne contamination - Guidance and fundamental requirements
- SS-EN-13795-2 - Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
- SS-EN-13824 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
- SS-EN-15424 - Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of sterilization process for medical devices
- SS-EN-16437 - Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
- SS-EN-16438 - Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
- SS-EN-1650 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
- SS-EN-16616 - Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
- SS-EN-17422 - Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of teat disinfectants used in the veterinary area - Test method and requirements (phase 2 step 2)
- SS-EN-556 - Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"
- SS-EN-556-1 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
- SS-EN-556-2 - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
- SS-EN-ISO-11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
- SS-EN-ISO-11135-1 - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
- SS-EN-ISO-11135-AM1 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
- SS-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, including Amd 1:2013)
- SS-EN-ISO-11137-1-AM2 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
- SS-EN-ISO-11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
- SS-EN-ISO-11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
- SS-EN-ISO-11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
- SS-EN-ISO-11138-2 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
- SS-EN-ISO-11138-3 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
- SS-EN-ISO-11138-4 - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
- SS-EN-ISO-11138-5 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
- SS-EN-ISO-11138-7 - Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
- SS-EN-ISO-11138-8 - Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
- SS-EN-ISO-11139 - Sterilization of health care products - Vocabulary - Terms used in sterilization and related equipment and process standards (ISO 11139:2018)
- SS-EN-ISO-11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
- SS-EN-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 11140-3:2007, including Cor 1:2007)
- SS-EN-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 11140-4:2007)
- SS-EN-ISO-11140-6 - Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
- SS-EN-ISO-11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
- SS-EN-ISO-11737-1-AM1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
- SS-EN-ISO-11737-2 - Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
- SS-EN-ISO-13408-1 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
- SS-EN-ISO-13408-2 - Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
- SS-EN-ISO-13408-3 - Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
- SS-EN-ISO-13408-4 - Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
- SS-EN-ISO-13408-5 - Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
- SS-EN-ISO-13408-6 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
- SS-EN-ISO-13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
- SS-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 (ISO 14160:2020)
- SS-EN-ISO-14161 - Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results (ISO 14161:2009)
- SS-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 (ISO 14937:2009)
- SS-EN-ISO-15882 - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
- SS-EN-ISO-17664-1 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
- SS-EN-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 17665-1:2006, IDT)
- SS-EN-ISO-18472 - Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
- SS-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)
- SS-EN-ISO-25424 - Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
- SS-EN-ISO-25424-AM1 - Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
- SS-ISO-13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products (ISO 13408-7:2012, IDT)
- SS-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, IDT)