What you print on your medical device is not only a matter of outlook and brand, but also regulated, compulsory information. There are different requirements coming from different versions of medical standards.
The standards state that all identifications and markings shall be permanently affixed. Nowadays, it means that the markings are either imprinted into the plastic cover, or printed onto sticker type labels. Typically, the information is collected on the device label, located near the mains input connection, or generally at the back or bottom of the device.
The second requirement for markings is that they shall be clearly legible, meaning that the size and contrast of text and symbols shall good enough for a person with normal vision to read. The special requirement for warning texts is that they need to be legible from the operator’s position.
Sometimes the size of equipment makes it difficult to include all markings on the device. In those instances there are minimum sets of markings with the rest being included in the accompanying documents.
Labelling required by 2nd Edition of Basic Standard IEC 60601-1
In the second edition of the Basic Standard the minimum requirements for information to be found on the labelling are:
- Indication of origin (manufacturer)
- Model or type reference
- Connection to electrical supply (if not permanently connected)
- Classification (electrical isolation, IP, patient connection)
- Warning of possible physiological effects (radiation etc).
There are additional requirements for information and markings, but these do not need to be printed on the device. They can, for example, cover special requirements for storing and unpacking the device.
Labelling required by 3rd Edition
In the third Edition the minimum requirements for labelling are:
- Manufacturer’s name or trademark
- Model – can be left out, if it cannot cause a hazard
- Type of electrical feed – model or type of source, if fed from another device, mains feed voltage, number of phases of type of current, frequency, possible symbol for class II device
- Patient connection type
- Warning of possible physiological effects
- Contact information for manufacturer (addition in Amendment 1)
- Serial number or lot/batch identification (Am1)
- Possible best before date for products with limited shelf life (Am1)
Other sources of labelling requirements
Collateral standards will bring new requirements for labelling. For example, EMC standard IEC 60601-1-2 states that devices intended only for shielded environment shall carry a warning for that purpose. The same standard requires also that if the device is transmitting radiofrequency signal, it must be equipped with an antenna symbol. Equipment used in home environment has requirements for IP classification and the device has to be labelled accordingly. Device specific standards will generate more requirements for labelling and required information.
In the future, all medical devices need to be identifiable through Unique Device Identification (UDI). That is part of the FDA’s current requirements and part of the forthcoming European Medical Device Regulation. The idea is to have device information in an easily machine readable format, a bar code that connects the specific unit to a common UDI database.
It should be noted that for example European directives and FDA/FCC requirements may bring additional requirements for labeling.
Change of symbols between different Editions
In the second Edition, the black and white symbol of a triangle with an exclamation mark has been used to mean “Attention, consult accompanying documents”. In the third Edition this symbol was replaced by a symbol of a book with the letter i for information. In addition to this, the third Edition requires manufacturers to use coloured warning symbols for hazards associated with not paying attention to the warning symbols. Use or colours is compulsory.
What is the difference between the black and white i-book symbol and the blue and white man-reading-book symbol? The black and white symbol is used when it is advisable to read the accompanying documents. The blue and white symbol tells the user that according to the manufacturer’s risk analysis, not reading the instructions can cause a hazard.
Instructions for use in electronic format?
Many manufacturers want to deliver all manuals and Instructions for Use in electronic format. This is not possible in all cases. The European Commission’s Regulation 207/2012 on electronic instructions for use of medical devices, allows the use of electronic instructions for specific device classes that are intended only for professional users. There are additional limitations, for example, risk analysis must support the equal or better safety of electronic instructions in comparison to paper documents.
- Global Harmonisation Task Force SG1/N70:2011 Label and Instructions for Use for Medical Devices
- European Commission’s Regulation 207/2012 (PDF 725 KB)
- FDA’s General Device Labeling Requirements
For further information, please contact:
Product Line Manager
SGS Fimko Oy
t: +358 40 560 9500