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Standards [CURRENT]

ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2014-07

Standards [CURRENT]

ISO 11135 AMD 1

Revision of Annex E, Single batch release
Edition 2018-10

Standards [CURRENT]

ISO 11136

Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area
Edition 2014-12

Standards [CURRENT]

ISO 11136 AMD 1

Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area; Amendment 1
Edition 2020-01

Standards [CURRENT]

ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2025-04

Standards [CURRENT]

ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Edition 2013-06

Standards [CURRENT]

ISO 11137-2 AMD 1

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Amendment 1
Edition 2022-06

Standards [CURRENT]

ISO 11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
Edition 2017-06

Pre-standard

ISO/TS 11137-4

Sterilization of health care products - Radiation - Part 4: Guidance on process control
Edition 2020-06

Standards [CURRENT]

ISO 11138-1

Sterilization of health care products - Biological indicators - Part 1: General requirements
Edition 2017-03

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