BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
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Publication date: 31/12/2016
Publisher: British Standards Institute (BSI)
Publication Status: Active
BS EN ISO 15223-1:2016 - Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
Many countries require that the information displayed on medical devices is in their own language, yet multiple languages can cause confusion and delay in locating the right version. As well, multiple languages can cause problems with translation, design and logistics. Finally, manufacturers may also want to take costs out of labelling by reducing the variants.
To help with all three issues, BS EN ISO 1522-1 supplies internationally recognized symbols with precisely defined descriptions that can appear on the medical device itself, as part of the label or be provided with the device.
Who is the standard for?
This standard is targeted at medical devices manufacturers and in vitro diagnostic product manufacturers. It is particularly relevant to manufacturers who market identical products in countries where there are different language requirements for medical device labelling.
It can 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 which are responsible for implementing regulations affecting medical devices and which have responsibility for post-market surveillance
- Consumers or end-users of medical devices who draw their supplies from a number of sources and can have varied language capabilities
What does the standard cover?
The standard lists symbols to be used with medical device labels, labelling and information to be supplied. The standard also identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
The symbols are used in a broad spectrum of medical devices which are marketed globally and therefore need to meet different regulatory requirements.
The standard is relevant to all medical device markets. It is also provides symbols for the in vitro diagnostic market.
Note: It is intended for this standard to be harmonized to the medical device directives.
How is the 2016 standard different from the 2012 version?
None of the symbols have been changed in this revision, only some the requirements. The principle revisions are:
- Clause 2 – updated the title of ISO 7000 and added the “date of release” for each of the registered symbols to Table 1
- Symbol 5.1.1 – modified the requirement related to the placement of the manufacturer’s name and address on IVD labels
- Symbol 5.1.2 – modified the requirement related to the placement of name and address of the authorized representative in the European Union on IVD labels
- Symbol 5.4.3 – added the information used to indicate an instruction to consult an electronic instructions for use (eIFU)
- Symbol 5.4.5 – added the reference to ISO 7000, symbol 2725, “Contains or presence of”
- Symbol 5.5.5 – modified the description of the symbol and the requirement regarding use with IVD
- A.15 – added the examples of the placement of the eIFU indicator.