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DIN EN 62304 VDE 0750-101 Berichtigung 1:2026-04

Medical device software

Software life-cycle processes

(IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015; Corrigendum 1
Class/Status: Standard, valid
Released: 2026-04
VDE Art. No.: 0701670

Note: You can pre-order this document (delivery subject to availability). Valid from 2026-04-01.

The corrigendum only applies to the German version DIN EN 62304 (VDE 0750-101):2016-10. This standard defines the life cycle requirements for medical device software. This corrigendum 1 corrects an entry in table A.1.

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
35	INFORMATION TECHNOLOGY. OFFICE MACHINES
35.020	Information technology (IT) in general
35.030	IT Security
35.040	Information coding
35.060	Languages used in information technology
35.080	Software. Programms
35.100	Open systems interconnection (OSI)
35.110	Networking
35.160	Microprocessor systems
35.200	Interface and interconnection equipment
35.240	Applications of information technology
35.260	Office machines

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DIN EN 62304 VDE 0750-101 Berichtigung 1:2026-04

Medical device software

Software life-cycle processes

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