The Official Journal of the EU published new harmonised standards for sterilizers for medical purposes and hearing aids. With Commission Implementing Decision (EU) 2026/760 published on 7 April, the European Commission amends Implementing Decision (EU) 2021/1182 and adds new entry to its Annex.
The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) revised existing harmonised standards in view of the latest technical and scientific progress.
New and revised harmonised standards for sterilizers and hearing aids
The revision of the standards resulted in the adoption of the following harmonised standards
- EN 13060:2025 on small steam sterilizers
- EN IEC 60118-0:2024 on electroacoustics
The newly added harmonised standard is the following:
- EN 14222:2021+A1:2025 on stainless steel steam boilers
Why harmonised standards?
Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in the applicable Regulation.
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References:
EUR-Lex (2026). Commission Implementing Decision (EU) 2026/760 of 1 April 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilizers for medical purposes – small steam sterilizers, stainless steel steam boilers and electroacoustics – hearing aids. Retrieved on 10/04/2026.
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