According to the essential requirements of the medical device directive, devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.
According to EN ISO 13485 :2016, processes for sterilization and sterile barrier systems shall be validated prior to implementation and following product or process changes, as appropriate.
Following the requirements of EN ISO 11607-2 process validation consists of 3 activities, which are referred to as IQ, OQ and PQ.
IQ is the process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification.
OQ is the process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures.
PQ is the process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification