AIDC Healthcare Implementation Guide - GS1

AIDC Healthcare Implementation Guide2.2. Medical DevicesMedical device means any instrument, apparatus, implement, machine, appliance, implant, in vitroreagent or calibrator, software, material or other similar or related article, intended by the manufacturerto be used, alone or in combination, for human beings for one or more of the specific purposes of:■■■■■■■Diagnosis, prevention, monitoring, treatment or alleviation of diseaseDiagnosis, monitoring, treatment, alleviation of or compensation for an injuryInvestigation, replacement, modification or support of the anatomy or of a physiologicalprocessSupporting or sustaining lifeControl of conceptionDisinfection of medical devicesProviding information for medical purposes by means of in vitro examination of specimensderived from the human body and which does not achieve its primary intended action in or onthe human body by pharmacological, immunological or metabolic means, but which may beassisted in its function by such means.3. Healthcare Product MarkingWhen adopting the GS1 standards for Healthcare product marking consideration should be given tothe following:■■■■AIDC Marking LevelsProduct ConfigurationPackage HierarchyDistribution ChannelThe following sections will more fully describe these areas of consideration to be used by theorganization(s) responsible for selection of the AIDC marking.Note: All products shown in this implementation guide are intended as examples. Please referto your local regulatory or trading partner requirements for more information.Note: All of the terms used in sections 3.1 and 3.2 are defined in section 3.3.3.1. Marking for Pharmaceutical ProductsThe following flow diagram will assist the reader in visualizing the navigation of Healthcare AIDCMarking for Pharmaceutical Products. This should be reviewed in conjunction with the GS1 GeneralSpecifications and the Pharmaceutical Marking Grid (Figure 3-2). It describes the possiblecombinations of data content for AIDC marking of Healthcare Pharmaceutical trade items.Issue 1.1, Approved, Dec-2010 All contents copyright © GS1 Page 10 of 33