DIN EN 62366-1 VDE 0750-241-1:2021-08

Medical devices

Part 1: Application of usability engineering to medical devices

(IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020
Class/Status: Standard, valid
Released: 2021-08
VDE Art. No.: 0701324

The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified and presented to the National Committee members of IEC/SC 62A and to the Member Bodies of ISO/TC 210. A majority of the members of both committees that stated a position supported developing this amendment to address the identified issues while making no fundamental changes to the usability engineering process as originally conceived in IEC 62366-1:2015.

Replacement for:
DIN EN 62366-1 VDE 0750-241-1:2017-07

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 » More Information