Standards catalogue

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

Medical devices -- Validation and routine control of ethylene oxide sterilization

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

Revision of Annex E, Single batch release

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 -- Requirements for validation and routine control -- Radiation sterilization

Selection of items for dose setting

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

Revision to 4.3.4 and 11.2

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

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 -- 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

Annex C: Alternative method for determining the D-value of LTSF SCBI

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

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 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 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 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 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizers

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 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 medical devices -- 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 -- 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

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

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

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

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

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

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

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

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 -- Guidance on the application of ISO14937 to the sterilization of medical devices using Ethylene Oxide in a flexible sterilization chamber

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

Traditional Chinese medicine -- Infection control for acupuncture treatment

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 forterminal sterilization of medical devices in health care facilities

Sterilization of healthcare products -- Microbiological Methods-- Guidance on conducting bioburden determinations and tests of sterility for 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