Medical device software. Software life-cycle processes Ingestion-build-67170 4 kPa (ga) [15 psig]

4 kPa (ga) [15 psig]

While the recommendations given in this part of BS EN ISO 9241 apply to a wide range of available front-end technologies

for which the main requirement is their resistance to the effects of hot gases and products of combustion at temperatures above 550 8C

6 Service conditions 6

Annex C (normative) Polyester moulding compound production testing

Medical device software. Software life-cycle processes Ingestion-build-67170 4 kPa (ga) [15 psig]What is this standard about? It deals with medical device software. The amendment adds requirements for legacy software which will help manufacturers demonstrate compliance with the relevant European Directives. Who is this standard for? The standard is relevant to manufacturers of: Medical electrical equipment Medical devices incorporating software Software that is itself a medical device Why should you use this standard? The amended standard applies