Standards expertise

What are the steps that make up validation in accordance with EN ISO 13849-2?

Question: Validation of safety functions in compliance with the standard: ISO 13849-2 names several procedures such as analysis, testing, verification and validation. How can you use them to derive a structure, so that the result represents a correct validation? Is it correct to say that validation does not exist "as such", but rather that all activities such as testing, analysis, function test etc. represent validation when performed in a structured manner and documented?

Answer: Validation in accordance with EN ISO 13849-2 is made up of several steps, which depend on the complexity of the application. Validation includes quantitative evidence with regard to the safety functions (verification of the Performance Level), functional tests, plus other functional analyses and tests - including with respect to documentation.
As explained in the question therefore, validation is all the various steps involved in the analysis and function test, with full documentation.


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