BS EN IEC 60601-2-57:2023/prAA:2025. 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
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Standard number:
25/30528364 DC
Pages:
9
Released:
2025-06-06
Status:
Draft for Comment
Pages (English):
9
DESCRIPTION
25/30528364 DC
This standard 25/30528364 DC BS EN IEC 60601-2-57:2023/prAA:2025. Medical electrical equipment is classified in these ICS categories:
11.040.50 Radiographic equipment
11.040.60 Therapy equipment
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.
