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Influence of materials on water intended for human consumption - Influence due to migration - Prediction of migration from organic materials using mathematical modelling
60.60 Standard published
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
90.20 Standard under periodical review
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
60.60 Standard published
General requirements for in vitro diagnostic medical devices for self-testing
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
60.60 Standard published
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
90.93 Standard confirmed
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
90.93 Standard confirmed
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
90.93 Standard confirmed
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
90.92 Standard to be revised
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
60.60 Standard published
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
90.92 Standard to be revised
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
60.60 Standard published
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)
60.60 Standard published
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)
60.60 Standard published
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)
60.60 Standard published
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
60.60 Standard published