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DEK rules and standards

Standards [CURRENT]

CSA C22.2 No. 60601-2-66

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (Adopted IEC 60601-2-66:2019, third edition, 2019-10, with Canadian deviations)
Edition 2021-07-01

Standards [CURRENT]

ABNT NBR IEC 60118-16

Electroacoustics - Hearing aids Part 16: Definition and verification of hearing aid features
Edition 2023-07-12

Medical electrical equipment Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
Edition 2020-09-29

Draft standard

24/30485512 DC

BS EN 60601-2-66 Medical electrical equipment. Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
Edition 2024-07-05

Standards [CURRENT]

UNE-EN IEC 60118-4/A1

Electroacoustics - Hearing aids - Part 4: Induction-loop systems for hearing aid purposes - System performance requirements
Edition 2018-05-16

Standards [CURRENT]

UNE-EN IEC 60118-16

Electroacoustics - Hearing aids - Part 16: Definition and verification of hearing aid features (Endorsed by Asociación Española de Normalización in June of 2022.)
Edition 2022-06-01

Standards [CURRENT]

UNE-EN IEC 60601-2-66

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (Endorsed by Asociación Española de Normalización in May of 2020.)
Edition 2020-05-01

Standards [CURRENT]

UNE-EN 60118-4

Electroacoustics - Hearing aids - Part 4: Induction-loop systems for hearing aid purposes - System performance requirements
Edition 2016-02-24

Standards [CURRENT]

AS 1088.3

Hearing aids Hearing aid equipment not entirely worn on the listener
Edition 1987

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