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Standards [CURRENT]

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
Edition 2018-10

Standards [CURRENT]

ISO 25424 AMD 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
Edition 2022-01

Technical rule [CURRENT]

ISO/TR 80002-2

Medical device software - Part 2: Validation of software for medical device quality systems
Edition 2017-06

Standards [CURRENT]

OENORM B 8110-6-2

Thermal insulation in building construction - Part 6-2: Validation of heating and cooling demand
Edition 2024-03-01

Standards [New]

OENORM EN ISO 4259-4

Petroleum and related products - Precision of measurement methods and results - Part 4: Use of statistical control charts to validate 'in-statistical-control' status for the execution of a standard test method in a single laboratory (ISO 4259-4:2021, Corrected version 2023-10)
Edition 2024-07-01

Water quality - Detection and enumeration of bacteriophages - Part 3: Validation of methods for concentration of bacteriophages from water (ISO 10705-3:2003)
Edition 2024-05-01

Draft standard

OENORM 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/DIS 11135:2024)
Edition 2024-02-01

Standards [CURRENT]

OENORM 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 + Amd 1:2018) (consolidated version)
Edition 2020-04-01

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
Edition 2023-05-15

Standards [CURRENT]

OENORM 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 + Amd.1:2013 + Amd.2:2018) (consolidated version)
Edition 2020-04-01

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