The 2007 update to the international standard on symbols used in medical device labeling will help users and manufacturers alike.
Users of medical devices benefit from the clarity offered by symbols. A device labeled in a number of different languages can cause the user confusion and lead to delay in locating the appropriate information.
For manufacturers, who seek to minimize the costs of labeling by reducing variants, a universal symbol can eliminate some of the problems inherent with translation, design, and logistics when multiple languages are included on a single label or piece of documentation.
The solution to these problems is the use of internationally recognized symbols with precisely defined meanings.
For instance, the hourglass symbol, accompanied by a date, indicates that the device should not be used after the end of the year, month, or day shown. By using the symbol, manufacturers need not provide a different version of their label in English, French, Spanish, Japanese, German, and so on, and do not need to attempt a “one-size-fits-all” label with a multitude of languages jumbled together, which makes it difficult for the user to navigate.
The updated standard now available from AAMI, ANSI/AAMI/ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied: — Part 1: General requirements, is the U.S. adoption of the ISO standard of the same name. It replaces the 2000 edition of the standard as well as two amendments issued in 2001 and 2004, which added a number of new symbols. The new standard includes 31 symbols that cover key areas such as biological risks, sterility and re-use, atmospheric conditions and limitations, manufacturing and use-by data, control numbers, and so on.
ANSI/AAMI/ISO 15223-1 addresses symbols that may be used to convey information that is considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the device in most regulatory domains. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems for device manufacturers and users.
The updated standard is primarily intended to be used by manufacturers of medical devices, who market the same products in countries having different language requirements for medical device labeling. The standard may also be of assistance to:
distributors of medical devices or other representatives of manufacturers;
healthcare providers responsible for training as well as those being trained;
those responsible for post- market vigilance;
healthcare regulatory authorities, testing organizations, certification bodies, and other organizations responsible for implementing regulations affecting medical devices and having responsibility for post-market surveillance; and
or end users of medical devices who draw their supplies from a number of sources and may have varied language capabilities.
Changes to the New Edition
In this new edition, a number of additional terms and definitions have been added to provide clarification. There are also new requirement sections on proposals for symbol adoption and requirements for usage, as well as four new annexes on examples, requirements to provide when proposing a new symbol, requirements for the basic symbol design, and use of the general prohibition symbol.
While compiling symbols to present in 15223-1, ISO/TC 210, which is administered by AAMI, came to recognize the need for systematic methodology for the development and presentation of symbols proposed for adoption. This will be the subject of a new international standard to be developed as 15223-2 on development, selection, and validation of symbols for inclusion in ISO 15223-1. The new standard may also be of use to manufacturers who need to validate symbols they are creating for their devices.
Proposing a New Symbol
When proposing a symbol for adoption into ISO 15223-1, the initiator of the request shall provide the following information:
A rationale for the development of the symbol with an assessment of how the use of the symbol can assist with safe and effective use with results of risk analysis for the substitution of the symbol for text.
Clear and unambiguous title and description for the symbol.
Identification of the intended users of the device(s) that will bear the symbol.
Details of existing or proposed symbols in the same or related applications.
Symbol original set out within the basic pattern following the principles of IEC 80416-1:2001.
Identification of any particular considerations such as orientation, which can affect legibility, reproduction, or understanding.
Details of any evaluation carried out on the use, comprehension, or acceptability of the symbol.
Detail of any existing registration or submission to a gatekeeper (ISO/TC 145 or IEC/SC 3C).
Proposals for further development, including validation.
The identity of the organization submitting the symbol(s), the relationship of the organization to ISO/TC 210, and the name and contact details of a person to whom correspondence should be addressed.
If the symbol is an existing symbol or based on existing symbology, elements of the above information can be provided by making reference to published documents.
When an entirely new symbol is presented for consideration or partly developed ideas are submitted for advice, as much of the above information as is available at the time, should be submitted. In addition, the symbol can be presented as a symbol concept.
Kurt Larrick is AAMI's director of technical publishing and marketing.