Biomaterial Database

Sterile by any other name. 1996

M E Donawa

Donawa and Associates Ltd., Rome, Italy.

Will manufacturers of CE-marked medical devices produced under aseptic conditions be able to label their products with the harmonized symbol for sterile? Perhaps not. This is because there are differences of opinion concerning the sterility assurance level that a European harmonized symbol for sterile should represent. This article will discuss the current proposed criteria for labelling a medical device with the European harmonized symbol for sterile, a more stringent approach, and some factors that should be taken into consideration before reaching any final decisions.

UI	MeSH Term	Description	Entries
D011356	Product Labeling	Use of written, printed, or graphic materials upon or accompanying a product or its container or wrapper. It includes purpose, effect, description, directions, hazards, warnings, and other relevant information.	Labeling, Product,Package Inserts,Product Labelling,Insert, Package,Inserts, Package,Labelling, Product,Package Insert
D003257	Consumer Product Safety	The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.	Safety, Consumer Product,Product Approval,Product Approvals,Product Safety, Consumer
D004616	Emblems and Insignia	Figures or symbols identifying or representing organizations or societies.	Caduceus,Flags,Flags and Banners,Insignia,Emblems,Insigne,Banners and Flags
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D005062	European Union	An economic union with the principal objectives of free movement of goods, capital, and labor. The constituent countries are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. (https://europa.eu/european-union/about-eu/countries accessed 12/31/2020)	Common Market,Euratom,European Atomic Energy Community,European Coal and Steel Community,European Common Market,European Community,European Economic Community,Community, European Economic,EEC,Economic Community, European,Common Market, European,Common Markets,Common Markets, European,Communities, European,Communities, European Economic,Community, European,Economic Communities, European,European Common Markets,European Communities,European Economic Communities,Market, Common,Market, European Common,Union, European
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.