
Medical device software Part 2: Validation of software for medical device quality systems
出版:International Organization for Standardization

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This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
DS ISO/TR 80002-2 : 2017 - Identical
DS ISO/TR 80002-2 : 2017 - Identical
AAMI ISO TIR 80002-2 : 2017 - Identical
BS PD ISO/TR 80002-2 : 2017 - Identical
NEN NPR ISO/TR 80002-2 : 2017 - Identical
AAMI ISO TIR 80002-2 : 2017 - Identical
NEN NPR ISO/TR 80002-2 : 2017 - Identical
BS PD ISO/TR 80002-2 : 2017 - Identical