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E DIN EN ISO 11197 VDE 0750-211:2025-05

Medical supply units

(ISO/DIS 11197:2024); German and English version prEN ISO 11197:2024
Class/Status: Draft, valid
Released: 2025 -05   Published: 2025-04 -04
VDE Art. No.: 1702109
End of objection deadline: 2025-06-04

This document applies to the basic safety and essential performance of MEDICAL SUPPLY UNITS, hereafter also referred to as ME equipment.
This document applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site, including joinery, cabinetry and other enclosures, which incorporate patient care services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the MEDICAL SUPPLY UNIT.