Life-Cycle is defined as per Clause 3.9 as "all phases in the life of a medical device, from the initial conception to final decommissioning and disposal."
Sterile Barrier System is defined as per Clause 3.19 as "minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use."
Sterile Medical Device is defined as per Clause 3.20 as "medical device intended to meet the requirements for sterility."
Medical Device Family is defined as per Clause 3.12 as "group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function."
Implantable Medical Device is defined as per Clause 3.6 as "medical device which can only be removed by medical or surgical intervention".
(Continued...)