DIN EN 82304-1 VDE 0750-102-1:2018-04

Health Software

Part 1: General requirements for product safety

(IEC 82304-1:2016); German version EN 82304-1:2017
Class/Status: Standard, valid
Released: 2018-04
VDE Art. No.: 0701127

Contents (only German)

This International Standard applies to the entire lifecycle including design, manufacture, installation, maintenance, and disposal of health software. This standard provides no requirements for software embedded in a medical device.

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 82304-1 VDE 0750-102-1:2018-04

Health Software

Part 1: General requirements for product safety

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