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  UNE-EN ISO 56001:2024





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Number of results 424

UNE
In force
2024-11-27

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

UNE
In force
2024-11-06

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 17664-2:2021)

UNE
In force
2024-11-06

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 (ISO 11139:2018/Amd 1:2024)

UNE
In force
2024-02-14

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

UNE
In force
2023-08-01

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) (Endorsed by Asociación Española de Normalización in August of 2023.)

UNE
In force
2023-07-19

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)

UNE
In force
2023-07-12

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

UNE
In force
2023-01-18

Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021)

UNE
In force
2022-12-21

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)

UNE
In force
2022-06-01

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)

UNE
In force
2022-03-16

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)

UNE
In force
2022-03-16

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

UNE
In force
2022-02-16

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

UNE
In force
2022-02-16

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)

UNE
In force
2022-01-19

Accessibility requirements for sign elements in buildings.

UNE
In force
2021-09-08

Accessibility and usability of the built environment - Functional requirements

UNE
In force
2021-09-01

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) (Endorsed by Asociación Española de Normalización in September of 2021.)

UNE
In force
2020-12-16

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)

UNE
In force
2020-10-14

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)

UNE
In force
2020-07-22

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)

UNE
In force
2020-07-22

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)

UNE
In force
2020-04-01

Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)

UNE
In force
2020-04-01

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)

UNE
In force
2020-02-12

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

Number of results 424