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Standards [CURRENT]

CAN/CSA-C22.2 No. 60601-1-6

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Adopted IEC 60601-1-6:2010, third edition, 2010-01, consolidated with amendment 1:2013 and amendment 2:2020, with Canadian deviations)
Edition 2022

Standards [CURRENT]

CAN/CSA-ISO/IEC 25066

Systems and software engineering - Systems and software Quality Requirements and Evaluation (SQuaRE) - Common Industry Format (CIF) for Usability - Evaluation Report (Adopted ISO/IEC 25066:2016, first edition, 2016-06-15)
Edition 2018-01-01

Standards [CURRENT]

CSA ISO 9241-11

Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts (Adopted ISO 9241-11:2018, second edition, 2018-03)
Edition 2019-10-01

Effizient DIN EN 62366-1- und FDA-konform dokumentieren
Edition 2020-12

Draft standard [New]

ISO/FDIS 25062

Systems and software engineering - Systems and software Quality Requirements and Evaluation (SQuaRE) - Common Industry Format (CIF) for reporting usability evaluations
Edition 2024-10

Technical rule [CURRENT]

IEC/TR 62366-2

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
Edition 2016-04

Standards [CURRENT]

ABNT ISO/TR 16982

Ergonomics of human-system interaction - Usability methods supporting human-centred design
Edition 2014-03-11

Usability of consumer products and products for public use Part 2:Summative test method
Edition 2016-12-13

Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Edition 2022-01-06

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