Urocare | News - Universal Standard Adopted

At Urocare, we are dedicated to delivering the highest standard of quality in medical products. The growing requirement to translate product labeling highlights the importance of using symbols. The use of internationally recognized symbols and marks is the only effective way to meet the requirements of a global market. To that end Urocare has adopted a universal standard for reference symbols used in the labeling its products (EN 980). Look for these symbols on all products as of February 13, 2009. The information provided below is only a partial explanation of reference symbols that can be found on various product labels.

Regulatory Agencies:
Agencies responsible for standards development and governing the use of standards containing these reference symbols can be found here:

ANSI - American National Standards Institute
FDA - United States Food and Drug Administration
ISO - The International Organization for Standardization
EN - European Norm. (developed under CEN mandate)

Frequently Asked Questions:
1. Can any reference symbol be used?

Not all symbols are accepted worldwide; thus, the use of any particular symbol must be one found in an applicable standard. Only symbols found in regulated standards are used on Urocare product labeling.

2. Are symbols approved for use in the United States?

The US FDA announced on April 28th, 2003 that they would recognize two standards associated with symbols, ISO 15223 "Symbols to be used with medical device labels, labeling and information to be supplied", and EN 980, "Graphical symbols for use in the labeling of medical devices". Within these standards there is a subset of symbols that are acceptable for use on US Medical Device labeling. These symbols can be found in Appendix II.

3. Are there some symbols that must be on all levels of packaging?

Symbols may be used in place of text or in addition to text. If the text is required on a specific level of packaging, then the corresponding symbol will be required as replacement for that text. Product characteristics determine which symbols are used and on which levels of packaging they are required.

Commonly Used Symbols: (Partial List)

SYMBOL	EXPLINATION
	Reference Number—Symbol that appears adjacent to the item's "Catalog" number also commonly referred to as the "Item" or "Reorder" number.
	Serial Number—Symbol that is commonly followed by or placed above, the manufacturer's serial number.
	Lot Number—Symbol placed adjacent to the manufacturer's lot number. The lot number may also be referred to as the batch code or batch number.
	Symbol indicating the "Date of Manufacture." The symbol should be adjacent to the date that the product was manufactured, expressed as four digits for the year and two digits for the month and where appropriate, two digits for the day.
	Symbol for "Use By." This symbol shall be adjacent to the expiration date, as given in EN 28601, expressed as four digits for the year and two digits for the month and where appropriate, two digits for the day. This symbol is intended to indicate that the device should not be used after the end of the month shown, or the day, if applicable.
	Symbol for sterile medical devices processed using "Aseptic" techniques.
	Symbol for method of sterilization using "Ethylene Oxide (EO)."
	Symbol for method of sterilization using "Irradiation."
	Symbol indicating that the device has *not* been sterilized. This symbol is used when there is a likelihood that a non-sterile item may be presumed to be sterile.
	Single Use Only—Symbol that signifies *"Do Not Reuse/Single Use Only"* for disposable one-time use products.
	Attention—Symbol commonly found in instruction manuals and used to direct the "attention" of the user to critical information about the use of a product. Often followed by the words "See Instructions for Use".