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Pre-standard

ISO/TS 21387

Sterilization of medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Edition 2020-09

Standards [CURRENT]

ISO 21474-2

In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 2: Validation and verification
Edition 2022-05

Standards [CURRENT]

ISO 21899

Biotechnology - Biobanking - General requirements for the validation and verification of processing methods for biological material in biobanks
Edition 2020-06

Pre-standard

ISO/TS 22176

Cosmetics - Analytical methods - Development of a global approach for validation of quantitative analytical methods
Edition 2020-01

Standards [CURRENT]

ISO 22183

Plastics - Validation of force-time curves obtained from high-speed tensile tests
Edition 2023-05

Standards [CURRENT]

ISO 22441

Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2022-08

Standards [CURRENT]

ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Edition 2007-12

Technical rule [CURRENT]

ISO/TR 22442-4

Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Edition 2010-12

Pre-standard

ISO/TS 23031

Graphic technology - Assessment and validation of the performance of spectrocolorimeters and spectrodensitometers
Edition 2020-08

Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products
Edition 2021-08

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