A voluntary consensus standard can result in the summation of the best existing practices and techniques in an industry that were in use prior to its publication, and this collective approach can be used to heighten competitiveness, increase efficiency, or assure safety. For practices in many industries, however, these benefits of standardization directly influence each other. For example, with medical devices, standardized labeling is responsible for a heightened efficiency, as it eliminates confusion with their use, which in turn makes the products safer by reducing the likelihood of errors.
The international standard symbols selected to be used with medical device labels are listed in ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements. This document includes visual examples of the symbols themselves, along with their titles, what they represent, and any other notes on their restrictions or requirements for use. Some of these symbols are intended simply to convey information from the manufacturer to the product user that bears no affiliation to the product’s use. For example, ISO 15223-1 includes the following:
The symbol on the left is the official international symbol for “manufacturer,” according to the standard, and, as specified in the document, it is to be followed by the name and address of the manufacturing company, along with the date of manufacture, in some instances.
Many of the symbols specified for medical device labeling in ISO 15223-1:2021 also derive from more-customary origins. Despite the fact that these symbols are generally used as de facto standards, even outside of the medical industry, it is completely necessary for them to have been included within this voluntary consensus standard. Through official standardization, the medical industry is able to put an end to any ambiguity or redundancy when it comes to device labels, reaffirming the symbols chosen for labeling. Some examples of these include:
The symbol on the left represents “caution,” indicating that the product user should proceed with caution, further examining the packaging for directions, while the one on the right is for “biological risk,” indicating that there are potential biological risks that can emerge while using the product. While each of these are well-known symbols, the ISO 15223-1:2021 document describes them and their purpose in depth.
Some well-established symbols that objectively contain little-to-no relevance to medical devices should also be used in accordance with the standard. This is because their images are so common throughout different cultures that they can convey the same idea to almost anyone. Examples of these symbols are:
The symbol on the left clearly illustrates an umbrella under rainfall, while the one on the right is a wineglass. These, when appearing on medical device labels, represent “keep dry” and “fragile, handle with care,” respectively.
While intended to provide a means of communication between manufacturers and individuals of different nations and linguistic backgrounds, some of the symbols include the actual name of what they represent, written in English. However, this doesn’t seem to negate the intentions of the standard in any way, since the representation still follows a shared structure in which the words in the symbol, if not legible, can still be comprehended by their shape. ISO 15223-1:2021 also states that these symbols should be given further descriptions in some parts of the world. An example of this is the symbol representing the presence of latex:
ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements is available on the ANSI Webstore. Guidelines for the selection of these symbols are covered in ISO 15223-2:2010 – Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation.
These standard documents can be acquired together through the ISO 15223 – Symbols for Medical Devices Package, available only on the ANSI Webstore.
1. International Organization for Standardization (ISO), ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (Geneva: ISO, 2021), 28.
2. International Organization for Standardization (ISO), ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (Geneva: ISO, 2021), 20.
3. International Organization for Standardization (ISO), ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (Geneva: ISO, 2021), 19.
4. International Organization for Standardization (ISO), ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (Geneva: ISO, 2021), 17.
5. International Organization for Standardization (ISO), ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (Geneva: ISO, 2021), 17.
6. International Organization for Standardization (ISO), ISO 15223-1:2021 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (Geneva: ISO, 2021), 20.
