Standards
ISO 18113-1:2022
ISO 18113-1:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
Standards
ISO 21856:2022
ISO 21856:2022 Assistive products — General requirements and test methods
Standards
ISO 10993-10:2021
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Standards
ISO 11607-2:2019
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Standards
ISO/TR 24971:2020
ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971
Standards
ISO 14971:2019
ISO 14971:2019 Medical devices — Application of risk management to medical devices
Standards
ISO/TR 21582:2021
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
Standards
ISO 17664-1:2021
ISO 17664-1:2021 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
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