We have products certified to 60601-1 2nd edition, which we are just now starting to get certified for 3rd edition.
The risk management philosophy embedded in the 3rd edition is for the full product life cycle, and risk management as specified in ISO 14971 is called for from the start of the product design process.
Unless the manufacturer was prescient enough to apply ISO 14971 in its design process before this was mandated by the 3rd edition of 60601-1, how can any product designed prior to the 3rd edition comply with its risk management requirements?
Or to put it more concretely, how are testing houses dealing with this issue?
Eamon Egan
The risk management philosophy embedded in the 3rd edition is for the full product life cycle, and risk management as specified in ISO 14971 is called for from the start of the product design process.
Unless the manufacturer was prescient enough to apply ISO 14971 in its design process before this was mandated by the 3rd edition of 60601-1, how can any product designed prior to the 3rd edition comply with its risk management requirements?
Or to put it more concretely, how are testing houses dealing with this issue?
Eamon Egan