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Standards [CURRENT]

ISO 11737-2

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Edition 2019-12

Draft standard [New]

ISO/DIS 14155

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2024-06

Standards [CURRENT]

ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2020-07

Standards [CURRENT]

ISO 15223-2

Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
Edition 2010-01

Standards [CURRENT]

ISO 15309

Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
Edition 2013-12

Standards [CURRENT]

ISO 16428

Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
Edition 2005-04

Standards [CURRENT]

ISO 16429

Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
Edition 2004-07

Standards [CURRENT]

ISO 17664-1

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
Edition 2021-07

Standards [CURRENT]

ISO 17664-2

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
Edition 2021-02

Technical rule [CURRENT]

ISO/TR 21582

Pyrogenicity - Principles and methods for pyrogen testing of medical devices
Edition 2021-07

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