DIN EN 62304 VDE 0750-101:2016-10

Medical device software

Software life-cycle processes

(IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
Class/Status: Standard, valid
Released: 2016-10
VDE Art. No.: 0701048

Contents (only German)

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE 68 SOFTWARE life cycle PROCESSES.

Replacement for:
DIN EN 62304 VDE 0750-101 Berichtigung 1:2009-05
DIN EN 62304 VDE 0750-101:2007-03

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

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 0750-101:2016-10

Medical device software

Software life-cycle processes

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