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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.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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Title		Format
	Prinz, Thorsten (Hrsg.) Entwicklung und Herstellung medizinischer Software Normen in der Medizintechnik VDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich

Prinz, Thorsten (Hrsg.)

Entwicklung und Herstellung medizinischer Software

Normen in der Medizintechnik
VDE-Schriftenreihe – Normen verständlich, Band 171

2017, 219 pages, Din A5, Broschur

Dieser Buchtitel ist auch als E-Book (PDF) erhältlich

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

Medical supply units

Entwicklung und Herstellung medizinischer Software

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