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Standards [CURRENT]

ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Edition 2020-01

Standards [CURRENT]

ISO 10993-18 AMD 1

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor
Edition 2022-05

Pre-standard

ISO/TS 10993-19

Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Edition 2020-03

Pre-standard

ISO/TS 10993-20

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
Edition 2006-08

Technical rule [CURRENT]

ISO/TR 10993-22

Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
Edition 2017-07

Standards [CURRENT]

ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation
Edition 2021-01

Technical rule [CURRENT]

ISO/TR 10993-33

Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
Edition 2015-03

Technical rule [CURRENT]

ISO/TR 10993-55

Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity
Edition 2023-02

Pre-standard

ISO/TS 11633-1

Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1: Requirements and risk analysis
Edition 2019-08

Technical rule [CURRENT]

ISO/TR 11633-2

Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 2: Implementation of an information security management system (ISMS)
Edition 2021-02

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