Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products

Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 — Technical Corrigendum 1

Medical devices — Validation and routine control of ethylene oxide sterilization

Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrigendum 1

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

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

Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1

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

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Technical Corrigendum 1

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

Sterilization of health care products — Radiation — Part 4: Guidance on process control

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose setting

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Technical Corrigendum 1

Sterilization of health care products — Biological indicators — Part 1: General

Sterilization of health care products — Biological indicators — Part 1: General requirements

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

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

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

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat 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 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 processes

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes

Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results

Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator

Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

Sterilization of health care products — Vocabulary

Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions

Sterilization of health care products — Vocabulary

Sterilization of health care products — Chemical indicators — Part 1: General requirements

Sterilization of health care products — Chemical indicators — Part 1: General requirements — Amendment 1

Sterilization of health care products — Chemical indicators — Part 1: General requirements

Sterilization of health care products — Chemical indicators — Part 1: General requirements

Sterilization of health care products — Chemical indicators — Part 2: Test equipment and methods

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicators for steam penetration test sheets

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test — Technical Corrigendum 1

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators for steam penetration test packs

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

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

Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for air removal test sheets and packs

Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

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

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management

Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly

Packaging for terminally sterilized medical devices

Packaging for terminally sterilized medical devices

Sterilization of medical devices — Microbiological methods — Part 1: Estimation of population of microorganisms on products

Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products

Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Technical Corrigendum 1

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1

Sterilization of health care products — 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 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

Aseptic processing of health care products — Part 1: General requirements

Aseptic processing of health care products — Part 1: General requirements

Aseptic processing of health care products — Part 1: General requirements — Amendment 1

Aseptic processing of health care products — Part 1: General requirements

Aseptic processing of health care products — Part 2: Filtration

Aseptic processing of health care products — Part 2: Sterilizing filtration

Aseptic processing of health care products — Part 3: Lyophilization

Aseptic processing of health care products — Part 4: Clean-in-place technologies

Aseptic processing of health care products — Part 5: Sterilization in place

Aseptic processing of health care products — Part 6: Isolator systems

Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1

Aseptic processing of health care products — Part 6: Isolator systems

Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches

Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches

Sterilization of health care products — Requirements for validation and routine control of moist heat sterilization in health care facilities

Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants

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

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

Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results

Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results

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

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 — Technical Corrigendum 1

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

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

Sterilization of health care products — Radiation sterilization — Selection of sterilization dose for a single production batch

Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results

Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests — Amendment 1

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy

Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy

Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noncritical medical devices and health care equipment

Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment

Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

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

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

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification

Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1

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

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Manufacture of cell-based health care products — Control of microbial risks during processing

Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1

Sterilization of health care products — Biological and chemical indicators — Test equipment

Sterilization of health care products — Biological and chemical indicators — Test equipment

Sterilization of health care products — Application of ISO/TS 22421 to the requirements for sterilizers used for the terminal sterilization of health care products containing aqueous liquid in sealed containers

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

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

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

Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

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