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EN IEC 60601-2-57:2026/A11:2026 Standard

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  Keywords:

#annexes #publications #european #standard #regulation

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Monday 9th of November 2026

  Description:

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

  Purpose

The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered). These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

  Publication

Monday 9th of November 2026

  Amendment

This standard is an amendment for "EN IEC 60601-2-57:2026"

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