Reminder of Key ChangesUnder EN ISO 14971:2009
ISO 14971:2007 (and EN ISO 14971) madefundamental changes from the original 2000directive in considering potential risk:
Phase of the Life Cycle
: Requirements 7.1and 7.3.2 addressed the need to examinedifferent stages of the product, includingmanufacture, product release, in-use errorsand disposal.
Type of Hazard
: This version of thestandard distinguishes between hazard(potential source of harm) and hazardoussituation (circumstance in which people,property, or the environment are exposed toone or more hazards). The risks must beestimated for both.
Confirmation of Standard Applicability
toall medical devices, including in vitrodiagnostic devices (IVDs), for which aspecific annex (H) was added about theidentification of hazards.